Category: 3. Business

  • Chinese Export Boom Can’t Stop Economy’s Slowdown

    Chinese Export Boom Can’t Stop Economy’s Slowdown

    (Bloomberg) — China’s economy probably grew at the slowest in a year during the third quarter despite a boom in exports, in a disconnect the Communist Party may move to rectify at a key meeting in the coming week.

    As trade tensions escalate with the US, weakness in investment, industrial output and retail sales is undermining momentum from record sales abroad. Data due on Monday from China’s National Bureau of Statistics will show gross domestic product rose 4.7% in the quarter from a year earlier, according to the median estimate in a Bloomberg survey, down from 5.2% in the prior three months.

    Retail sales are forecast to have expanded 3% in September and industrial output to have climbed by 5% — the weakest outcomes this year for both.

    Meanwhile, fixed-asset investment is forecast to have slowed again in the first nine months, to be unchanged from a year earlier. It’s been plunging since May despite a massive expansion in government borrowing meant to support the spending power of local authorities. Public spending on infrastructure hasn’t been enough, though, to make up for a slump in housing investment and the slowdown in money going to manufacturing.

    Foreign firms have also been pulling back on outlays, with inbound new foreign direct investment down almost 13% in the first eight months, putting China on track for three straight years of declines. One bright spot is foreign demand, with the goods trade balance so far this year hitting a record $875 billion, according to the latest figures.

    The economic fragility sets the tone for the upcoming gathering of party officials at the so-called fourth plenum in Beijing. The huddle will provide clues on their priorities for 2026-2030, as governments and investors around the world call for a rebalancing of China’s economy toward domestic consumption.

    What Bloomberg Economics Says:

    “Beijing now faces deep structural headwinds — from fading growth drivers to a protracted property downturn and entrenched deflation — unlike the severe, yet temporary pandemic shocks during the last five-year planning stage. With the US ratcheting up trade and tech restrictions, the external environment has also turned sharply adverse. This time, the transition is no longer a distant goal — it’s imperative.”

    —Chang Shu, chief Asia economist. For full analysis, click here

    The IMF, which just kept its prediction for China’s 2025 growth at 4.8%, expects a slowdown next year to 4.2% — an outlook in line with the median forecasts of economists surveyed by Bloomberg. The fund warned that “China’s prospects remain weak,” saying “real estate investment continues to shrink while the economy teeters on the verge of a debt-deflation cycle.”

    “Rebalancing toward household consumption — including through fiscal measures with a greater focus on social spending and the property sector — and scaling back industrial policies would reduce external surpluses and alleviate domestic deflationary pressures,” the IMF officials said in their global economic outlook.

    Elsewhere, inflation data from Japan to the UK, purchasing manager indexes from major economies, and the first summary of a meeting by Swiss central bank officials will be among the highlights.

    Click here for what happened in the past week, and below is our wrap of what’s coming up in the global economy.

    US and Canada

    After being delayed by the US government shutdown, the Bureau of Labor Statistics will release of the September consumer price index on Friday. The data, originally slated for Oct. 15, will give Federal Reserve officials a critical piece of information on inflation ahead of their policy meeting the following week.

    Economists in a Bloomberg survey forecast the core CPI, which excludes food and fuel for a better snapshot of underlying inflation, to have climbed 0.3% for a third straight month as higher import duties continue to gradually filter through to consumers. The projected monthly gain will keep the annual core CPI at 3.1%.

    While most official economic data releases have been delayed, BLS staff were called in despite the shutdown to prepare the September CPI report, which informs next year’s cost-of-living adjustments for Social Security recipients.

    Although inflation is stuck above their goal, Fed officials are expected to announce their second rate cut of the year following a two-day meeting on Oct. 28-29 because of the fragile labor market.

    Among private-sector economic data on the agenda, a National Association of Realtors report on Thursday will probably show contract closings on purchases of previously owned homes stayed tepid in September. An S&P Global PMI release on Friday is projected to illustrate modest growth in manufacturing and services activity.

    For more, read Bloomberg Economics’ full Week Ahead for the US Asia

    Apart from the busy week in China, Japan reports national CPI figures on Friday expected to show that consumer inflation remained well above the Bank of Japan’s target in September, while purchasing manager indexes the same day may show manufacturing activity shrinking for a fourth straight month, even as services marked a full year of expansion.

    India’s September PMI figures will likely show manufacturing activity remains robust. New Zealand reports quarterly inflation data, while Malaysia, Singapore and Hong Kong release September CPI.

    Monthly trade data are due from New Zealand, Thailand and Japan, while South Korea will release 20-day trade statistics for October.

    On the policy front, China is likely to hold its 1- and 5-year loan prime rates steady on Monday. Bank Indonesia will mull another cut to its benchmark rate on Wednesday as it weighs benign inflation against the weakening rupiah.

    A day later, the Bank of Korea is expected to hold its base rate steady at 2.50% while possibly foreshadowing a cut in November as inflation stays subdued and economic growth cools. Uzbekistan sets rate policy on Thursday.

    For more, read Bloomberg Economics’ full Week Ahead for Asia Europe, Middle East, Africa

    The week’s highlight may be the initial reading of October purchasing manager indexes across western Europe.

    These will reveal how manufacturing and services companies in Germany, France and the UK assessed the activity at the start of the fourth quarter, pointing to any momentum — or lack thereof — at a time when President Donald Trump’s tariffs are squeezing exports to the US.

    In terms of hard data, Britain may draw the most attention. Public finance numbers on Tuesday will inform Chancellor Rachel Reeves as she prepares for a fraught budget in November.

    Inflation the following day will be crucial both for Reeve’s plans and the Bank of England, which is inching toward further rate cuts while nervously monitoring still-strong price pressures. The data are likely to show acceleration to 4%, the fastest in 1 1/2 years.

    In the euro zone, several European Central Bank speakers will deliver remarks before a pre-decision quiet period kicks in on Thursday. Among them will be Executive Board members Isabel Schnabel and Philip Lane on Monday, and President Christine Lagarde on Wednesday.

    Meanwhile, France’s ongoing struggles to pass a budget are likely to continue after Prime Minister Sebastien Lecornu survived two no-confidence votes in the past week. Political strife could yet force the collapse of his government.

    The situtation was exacerbated by Friday night’s unscheduled move by S&P Global Ratings to downgrade the country. The move means France has lost its double-A rating at two of the three major credit assessors in little more than a month, potentially forcing some funds with ultra-strict investment criteria to sell the country’s bonds.

    An update at Moody’s Ratings is due at the end of the coming week, though the firm currently has a stable outlook on the country.

    Belgium is also on the calendar for a possible review from S&P Global Ratings, whose view on its credit score is already skewed negative.

    In Switzerland on Tuesday, September export numbers will offer a glimpse into the country’s trade position at the end of a quarter when it got slapped with the highest US import tariffs of any advanced economy. The government cited those levies in cutting its growth forecast for next year.

    Thursday will be a watershed moment for the Swiss National Bank with the release of its first-ever summary of a rate meeting discussion, in an attempt to emulate the sort of transparency practiced by the Fed.

    Turning south, data on Wednesday will likely show South African inflation ticked up to 3.4% in September from 3.3%. That may again persuade policymakers to hold rates steady for a second consecutive meeting next month as they defend the South African Reserve Bank’s stricter 3% goal for price growth, which they signaled in July is their preferred level.

    A day later, the central bank will publish its semi-annual monetary policy review and Governor Lesetja Kganyago will offer more insights.

    For more, read Bloomberg Economics’ full Week Ahead for EMEA Some monetary decisions are scheduled around the region:

    On Tuesday, the National Bank of Hungary is set to keep its rate on hold at 6.5%, having rebuffed government calls for easing. Turkey’s central bank is likely to lower rates again on Thursday — by 100 basis points to 39.5%, according to a Bloomberg survey. Still, some in the poll expect a hold after price growth unexpectedly picked up in September to 33.3% year-on-year. The Bank of Russia will announce its latest rate decision on Friday, after cuts at the past three meetings brought the benchmark to 17%. Governor Elvira Nabiullina has warned that the widening federal budget deficit, driven by spending on the war in Ukraine, may limit room for further cuts. Latin America

    In a light week, Mexico may face a second straight month of negative GDP-proxy prints for August, due largely to more restricted public spending and Trump’s trade policies.

    In similar vein, August data from Argentina may show activity extending a slump as President Javier Milei’s shock therapy weighs on the economy.

    Also due from Argentina is Torcuato Di Tella University’s government confidence index, which is fresh off a tumble and may have taken another leg down amid a sell-off of the peso and local assets. Much is riding on how Milei fares in the Oct. 26 midterm elections.

    Providing regional contrast material, Colombia’s August GDP-proxy report comes on the heels of July data that showed growth got off to a blistering start in the second half, in line with central bank forecasts.

    Mid-month inflation reports from Brazil and Mexico are likely to show still-simmering price pressures.

    Sticky and elevated core readings are likely to keep Brazil’s central bank on hold at 15% into 2026, though readings in Mexico are very unlikely to see Banxico pause its easing cycle after 10 straight rate cuts.

    For more, read Bloomberg Economics’ full Week Ahead for Latin America –With assistance from Brian Fowler, Laura Dhillon Kane, Vince Golle, Monique Vanek, Robert Jameson, Mark Evans, Tony Halpin, Paul Abelsky and Paul Wallace.

    ©2025 Bloomberg L.P.

    Continue Reading

  • Chinese Export Boom Can’t Stop Economy’s Slowdown

    Chinese Export Boom Can’t Stop Economy’s Slowdown

    An Antong Holdings Co. container ship at the Port of Nansha in Guangzhou, China.

    China’s economy probably grew at the slowest in a year during the third quarter despite a boom in exports, in a disconnect the Communist Party may move to rectify at a key meeting in the coming week.

    Most Read from Bloomberg

    As trade tensions escalate with the US, weakness in investment, industrial output and retail sales is undermining momentum from record sales abroad. Data due on Monday from China’s National Bureau of Statistics will show gross domestic product rose 4.7% in the quarter from a year earlier, according to the median estimate in a Bloomberg survey, down from 5.2% in the prior three months.

    Retail sales are forecast to have expanded 3% in September and industrial output to have climbed by 5% — the weakest outcomes this year for both.

    Meanwhile, fixed-asset investment is forecast to have slowed again in the first nine months, to be unchanged from a year earlier. It’s been plunging since May despite a massive expansion in government borrowing meant to support the spending power of local authorities. Public spending on infrastructure hasn’t been enough, though, to make up for a slump in housing investment and the slowdown in money going to manufacturing.

    Foreign firms have also been pulling back on outlays, with inbound new foreign direct investment down almost 13% in the first eight months, putting China on track for three straight years of declines. One bright spot is foreign demand, with the goods trade balance so far this year hitting a record $875 billion, according to the latest figures.

    The economic fragility sets the tone for the upcoming gathering of party officials at the so-called fourth plenum in Beijing. The huddle will provide clues on their priorities for 2026-2030, as governments and investors around the world call for a rebalancing of China’s economy toward domestic consumption.

    What Bloomberg Economics Says:

    “Beijing now faces deep structural headwinds — from fading growth drivers to a protracted property downturn and entrenched deflation — unlike the severe, yet temporary pandemic shocks during the last five-year planning stage. With the US ratcheting up trade and tech restrictions, the external environment has also turned sharply adverse. This time, the transition is no longer a distant goal — it’s imperative.”

    —Chang Shu, chief Asia economist. For full analysis, click here

    The IMF, which just kept its prediction for China’s 2025 growth at 4.8%, expects a slowdown next year to 4.2% — an outlook in line with the median forecasts of economists surveyed by Bloomberg. The fund warned that “China’s prospects remain weak,” saying “real estate investment continues to shrink while the economy teeters on the verge of a debt-deflation cycle.”

    “Rebalancing toward household consumption — including through fiscal measures with a greater focus on social spending and the property sector — and scaling back industrial policies would reduce external surpluses and alleviate domestic deflationary pressures,” the IMF officials said in their global economic outlook.

    Elsewhere, inflation data from Japan to the UK, purchasing manager indexes from major economies, and the first summary of a meeting by Swiss central bank officials will be among the highlights.

    Click here for what happened in the past week, and below is our wrap of what’s coming up in the global economy.

    US and Canada

    After being delayed by the US government shutdown, the Bureau of Labor Statistics will release of the September consumer price index on Friday. The data, originally slated for Oct. 15, will give Federal Reserve officials a critical piece of information on inflation ahead of their policy meeting the following week.

    Economists in a Bloomberg survey forecast the core CPI, which excludes food and fuel for a better snapshot of underlying inflation, to have climbed 0.3% for a third straight month as higher import duties continue to gradually filter through to consumers. The projected monthly gain will keep the annual core CPI at 3.1%.

    While most official economic data releases have been delayed, BLS staff were called in despite the shutdown to prepare the September CPI report, which informs next year’s cost-of-living adjustments for Social Security recipients.

    Although inflation is stuck above their goal, Fed officials are expected to announce their second rate cut of the year following a two-day meeting on Oct. 28-29 because of the fragile labor market.

    Among private-sector economic data on the agenda, a National Association of Realtors report on Thursday will probably show contract closings on purchases of previously owned homes stayed tepid in September. An S&P Global PMI release on Friday is projected to illustrate modest growth in manufacturing and services activity.

    Asia

    Apart from the busy week in China, Japan reports national CPI figures on Friday expected to show that consumer inflation remained well above the Bank of Japan’s target in September, while purchasing manager indexes the same day may show manufacturing activity shrinking for a fourth straight month, even as services marked a full year of expansion.

    India’s September PMI figures will likely show manufacturing activity remains robust. New Zealand reports quarterly inflation data, while Malaysia, Singapore and Hong Kong release September CPI.

    Monthly trade data are due from New Zealand, Thailand and Japan, while South Korea will release 20-day trade statistics for October.

    On the policy front, China is likely to hold its 1- and 5-year loan prime rates steady on Monday. Bank Indonesia will mull another cut to its benchmark rate on Wednesday as it weighs benign inflation against the weakening rupiah.

    A day later, the Bank of Korea is expected to hold its base rate steady at 2.50% while possibly foreshadowing a cut in November as inflation stays subdued and economic growth cools. Uzbekistan sets rate policy on Thursday.

    Europe, Middle East, Africa

    The week’s highlight may be the initial reading of October purchasing manager indexes across western Europe.

    These will reveal how manufacturing and services companies in Germany, France and the UK assessed the activity at the start of the fourth quarter, pointing to any momentum — or lack thereof — at a time when President Donald Trump’s tariffs are squeezing exports to the US.

    In terms of hard data, Britain may draw the most attention. Public finance numbers on Tuesday will inform Chancellor Rachel Reeves as she prepares for a fraught budget in November.

    Inflation the following day will be crucial both for Reeve’s plans and the Bank of England, which is inching toward further rate cuts while nervously monitoring still-strong price pressures. The data are likely to show acceleration to 4%, the fastest in 1 1/2 years.

    In the euro zone, several European Central Bank speakers will deliver remarks before a pre-decision quiet period kicks in on Thursday. Among them will be Executive Board members Isabel Schnabel and Philip Lane on Monday, and President Christine Lagarde on Wednesday.

    Meanwhile, France’s ongoing struggles to pass a budget are likely to continue after Prime Minister Sebastien Lecornu survived two no-confidence votes in the past week. Political strife could yet force the collapse of his government.

    The situtation was exacerbated by Friday night’s unscheduled move by S&P Global Ratings to downgrade the country. The move means France has lost its double-A rating at two of the three major credit assessors in little more than a month, potentially forcing some funds with ultra-strict investment criteria to sell the country’s bonds.

    An update at Moody’s Ratings is due at the end of the coming week, though the firm currently has a stable outlook on the country.

    Belgium is also on the calendar for a possible review from S&P Global Ratings, whose view on its credit score is already skewed negative.

    In Switzerland on Tuesday, September export numbers will offer a glimpse into the country’s trade position at the end of a quarter when it got slapped with the highest US import tariffs of any advanced economy. The government cited those levies in cutting its growth forecast for next year.

    Thursday will be a watershed moment for the Swiss National Bank with the release of its first-ever summary of a rate meeting discussion, in an attempt to emulate the sort of transparency practiced by the Fed.

    Turning south, data on Wednesday will likely show South African inflation ticked up to 3.4% in September from 3.3%. That may again persuade policymakers to hold rates steady for a second consecutive meeting next month as they defend the South African Reserve Bank’s stricter 3% goal for price growth, which they signaled in July is their preferred level.

    A day later, the central bank will publish its semi-annual monetary policy review and Governor Lesetja Kganyago will offer more insights.

    Some monetary decisions are scheduled around the region:

    • On Tuesday, the National Bank of Hungary is set to keep its rate on hold at 6.5%, having rebuffed government calls for easing.

    • Turkey’s central bank is likely to lower rates again on Thursday — by 100 basis points to 39.5%, according to a Bloomberg survey. Still, some in the poll expect a hold after price growth unexpectedly picked up in September to 33.3% year-on-year.

    • The Bank of Russia will announce its latest rate decision on Friday, after cuts at the past three meetings brought the benchmark to 17%. Governor Elvira Nabiullina has warned that the widening federal budget deficit, driven by spending on the war in Ukraine, may limit room for further cuts.

    Latin America

    In a light week, Mexico may face a second straight month of negative GDP-proxy prints for August, due largely to more restricted public spending and Trump’s trade policies.

    In similar vein, August data from Argentina may show activity extending a slump as President Javier Milei’s shock therapy weighs on the economy.

    Also due from Argentina is Torcuato Di Tella University’s government confidence index, which is fresh off a tumble and may have taken another leg down amid a sell-off of the peso and local assets. Much is riding on how Milei fares in the Oct. 26 midterm elections.

    Providing regional contrast material, Colombia’s August GDP-proxy report comes on the heels of July data that showed growth got off to a blistering start in the second half, in line with central bank forecasts.

    Mid-month inflation reports from Brazil and Mexico are likely to show still-simmering price pressures.

    Sticky and elevated core readings are likely to keep Brazil’s central bank on hold at 15% into 2026, though readings in Mexico are very unlikely to see Banxico pause its easing cycle after 10 straight rate cuts.

    –With assistance from Brian Fowler, Laura Dhillon Kane, Vince Golle, Monique Vanek, Robert Jameson, Mark Evans, Tony Halpin, Paul Abelsky and Paul Wallace.

    Most Read from Bloomberg Businessweek

    ©2025 Bloomberg L.P.

    Continue Reading

  • T-DXd Superior to T-DM1 in Improving IDFS/DFS in Residual HER2+ Breast Cancer | Targeted Oncology

    T-DXd Superior to T-DM1 in Improving IDFS/DFS in Residual HER2+ Breast Cancer | Targeted Oncology

    Interim data from the phase 3 DESTINY-Breast05 trial (NCT04622319) shared at the 2025 European Society for Medical Oncology (ESMO) Congress showed improved invasive disease–free survival (IDFS) with fam-trastuzumab deruxtecan-nxki (T-DXd; Enhertu) gin compared with ado-trastuzumab emtansine (T-DM1; Kadcyla) in patients with high-risk, HER2-positive primary breast cancer with residual invasive disease following neoadjuvant therapy.1

    Treatment with T-DXd (n = 818) led to a 53% reduction in the risk of invasive disease or death compared with T-DM1 (n = 817; HR, 0.47; 95% CI, 0.34–0.66; P < .0001). The 3-year IDFS rates were 92.4% (95% CI, 89.7%–94.4%) with T-DXd vs 83.7% (95% CI, 80.2%–86.7%) with T-DM1.

    “Patients benefited [from T-DXd] irrespective of age cohorts, region of accrual, hormone receptor status, disease status at presentation, post-therapy pathologic nodal status, and dual or single HER2-targeted therapy, as well as irrespective of the sequence or usage of radiation therapy for that minority of patients who did not receive [radiation] treatment,” Charles E. Geyer Jr., MD, said in the presentation.

    Geyer is a professor of medicine and chief of the Division of Malignant Hematology and Medical Oncology at the University of Pittsburgh Medical Center Hillman Cancer Center in Pennsylvania.

    What Was the Rationale for DESTINY-Breast05?

    Previously, the phase 3 KATHERINE trial (NCT01772472 ) showed that T-DM1 improved IDFS (HR, 0.50; 95% CI, 0.39-0.64; P < .0001) and overall survival (OS; HR, 0.66; 95% CI, 0.51-0.87; P = .0027) compared with trastuzumab in patients with HER2-positive early breast cancer with residual invasive disease after neoadjuvant therapy.2 However, patients with advanced locoregional disease or positive nodal status following neoadjuvant therapy had 3-year IDFS rates of 76% and 83%, respectively; the 7-year IDFS rates were 67% and 72%, respectively.1 These data reinforce the unmet need for improved post-neoadjuvant treatment in this population, Geyer emphasized.

    What Was the Study Design?

    This global, multicenter, randomized, open-label trial enrolled patients with residual invasive disease in the breast and/or axillary lymph nodes after neoadjuvant chemotherapy with a HER2-directed therapy. Patients needed to present with high-risk disease prior to neoadjuvant therapy, defined as inoperable early breast cancer or operable early breast cancer with axillary node–positive disease after neoadjuvant therapy. Patients also needed to have centrally confirmed HER2-positive disease and an ECOG performance status of 0 or 1. Enrolled patients were stratified by extent of disease at presentation (inoperable vs operable), type of HER2-targeted neoadjuvant therapy received (single vs dual), hormone receptor status (positive vs negative), and post-neoadjuvant therapy pathologic nodal status (positive vs negative).

    Patients were randomly assigned 1:1 to receive intravenous (IV) T-DXd at 5.4 mg/kg every 3 weeks for 14 cycles, or IV T-DM1 at 3.6 mg/kg every 3 weeks for 14 cycles. Treatment was followed by a 40-day safety follow-up period.

    Notably, concomitant adjuvant endocrine therapy was allowed per local practice protocols. Additionally, radiotherapy, if administered, could be initiated concurrently with study therapy or completed prior to the initiation of study therapy per the investigator. An interstitial lung disease (ILD) monitoring program was required for patients who received radiotherapy.

    IDFS served as the primary end point, with disease-free survival (DFS) as a key secondary end point. Other secondary end points included OS, distant recurrence–free interval (DRFI), brain metastasis–free interval (BMFI), and safety.

    What Did the Patient Population Look Like?

    In total, 1635 patients were randomly assigned to receive T-DXd (n = 818) or T-DM1 (n = 817). In the T-DXd arm, 806 patients received treatment. A total of 27.7% of patients in this arm discontinued treatment due to adverse effects (AEs; 17.9%), patient withdrawal (7.4%), disease recurrence (0.2%), physician decision (1.9%), and protocol deviation (0.2%). In total, 72.3% of patients in this arm completed study treatment, and the median study duration was 29.9 months (range, 0.3-53.4).

    In the T-DM1 arm, 801 patients received treatment. A total of 23.7% of patients in this arm discontinued treatment due to AEs (12.7%), patient withdrawal (6.2%), disease recurrence (3.7%), physician decision (0.6%), protocol deviation (0.1%), and other reasons (0.1%). In total, 76.3% of patients in this arm completed study treatment, and the median study duration was 29.7 months (range, 0.1-54.4).

    In the T-DXd arm, the median age was 50.3 years (range, 24–78), Asian patients were the most predominant race (48.8%), and most patients had HER2 3+ disease by immunohistochemistry (IHC) (82.6%), hormone receptor–positive disease (71.0%), inoperable disease (52.7%), positive nodal status (80.7%), received dual HER2-targeted therapy with trastuzumab plus pertuzumab (77.9%), prior anthracycline use (51.7%), and received prior adjuvant radiotherapy (93.4%). In the T-DM1 arm, the median age was 50.6 years (range, 21-83), Asian patients were the most predominant race (47.2%), and the highest proportions of patients had HER2 3+ disease by IHC (82.0%), hormone receptor–positive disease (71.4%), inoperable disease (51.9%), positive nodal status (80.5%), received dual HER2-targeted therapy with trastuzumab plus pertuzumab (78.5%), prior anthracycline use (48.8%), and received prior adjuvant radiotherapy (92.9%).

    What Additional Efficacy Outcomes Were Observed?

    Overall, investigators observed lower rates of distant and local recurrences, including central nervous system (CNS) recurrences, with T-DXd vs T-DM1. The numbers of patients with recurrences in these respective arms were as follows:

    • Distant recurrence: n = 42 (non-CNS, n = 25; CNS, n = 17); n = 77 (non-CNS, n = 52; CNS, n = 25)
    • Local invasive recurrence: n = 1; n = 5
    • Regional recurrence: n = 1; n = 6
    • Contralateral invasive disease: n = 0; n = 6
    • Death without prior reported event: n = 7; n = 8

    A DFS benefit was observed with T-DXd vs T-DM1 (HR, 0.47; 95% CI, 0.34–0.66; P < .0001). The 3-year DFS rates were 92.3% (95% CI, 89.5%–94.3%) with T-DXd vs 83.5% (95% CI, 79.9%–86.4%) with T-DM1.

    DRFI, BMFI, and OS benefits were also seen with T-DXd vs T-DM1. The respective 3-year DRFI rates were 93.9% (95% CI, 91.4%–95.7%) and 86.1% (95% CI, 82.5%–89.1%); the HR was 0.49 (95% CI, 0.34–0.71) favoring the T-DXd arm. The respective 3-year BMFI rates were 97.6% (95% CI, 96.2%–98.5%) and 95.1% (95% CI, 93.6%–97.2%); the HR was 0.64 (95% CI, 0.35–1.17) favoring the T-DXd arm. The respective 3-year OS rates were 97.4% (95% CI, 95.8%–98.4%) and 95.7% (95% CI, 93.5%–97.2%); the HR was 0.61 (95% CI, 0.34–1.10) favoring the T-DXd arm.

    Regarding on-study treatment exposure, in the T-DXd arm, the median study treatment duration was 9.8 months, and 72.3% of patients completed the planned 14 cycles of therapy. In the T-DM1 arm, the median study treatment duration was 9.7 months, and 76.3% of patients completed the planned 14 cycles of therapy. Notably, patients who discontinued the study before receiving 14 cycles of study treatment were permitted to receive an additional HER2-targeted therapy per standard of care (SOC) guidelines to complete 14 total cycles of HER2-targeted adjuvant therapy.

    What Was the Safety Profile?

    In the T-DXd arm, any-grade treatment-emergent AEs (TEAEs) were reported in 99.5% of patients, and 50.6% of patients experienced grade 3 or higher TEAEs. Serious TEAEs (17.4%) and those associated with drug discontinuation (17.9%; drug-related ILD/pneumonitis, 10.8%), drug interruptions (49.6%), dose reductions (26.4%), and deaths (0.4%; ILD/pneumonitis, n = 2; respiratory tract infection adjudicated as not ILD, n = 1) also occurred.

    In the T-DM1 arm, any-grade TEAEs were reported in 98.4% of patients, and 51.9% of patients experienced grade 3 or higher TEAEs. Serious TEAEs (13.6%) and those associated with drug discontinuation (12.9%; drug-related ILD/pneumonitis, 2.5%), drug interruptions (41.1%), dose reductions (26.6%), and deaths (0.6%; leiomyosarcoma of the uterus, aneurysm, non-neutropenic sepsis, ovarian cancer, and traumatic pneumothorax, n = 1 each) also occurred.

    The most commonly reported TEAEs in the T-DXd and T-DM1 arms, respectively, were nausea (71.3%; 29.3%), constipation (32.0%; 16.2%), decreased neutrophil counts (31.6%; 14.4%), vomiting (31.0%; 9.0%), decreased white blood cell counts (29.7%; 13.0%), fatigue (29.5%; 20.2%), radiation pneumonitis (28.8%; 27.0%), anemia (28.3%; 17.0%), increased aspartate aminotransferase levels (25.6%; 50.2%), increased alanine aminotransferase levels (23.7%; 45.3%), diarrhea (23.2%; 8.6%), decreased platelet counts (21.2%; 49.8%), decreased appetite (20.0%; 10.0%), headache (15.8%; 20.7%), and arthralgia (10.3%; 20.5%).

    The rates of adjudicated drug-related ILD in the T-DXd and T-DM1 arms were as follows:

    • Any-grade: 9.6% vs 1.6%
    • Grade 1: 2.0% vs 1.0%
    • Grade 2: 6.5% vs 0.6%
    • Grade 3: 0.9% vs 0%
    • Grade 4: 0% vs 0%
    • Grade 5: 0.2% vs 0%

    No differences in adjudicated drug-related ILD instances were observed based on adjuvant radiotherapy timing (sequential or concurrent). Investigators observed similar distributions of any-grade adjudicated drug-related ILD events with sequential (T-DXd arm, 10.7%; T-DM1 arm, 2.6%) and concurrent (9.6%; 1.0%) radiotherapy.

    The rates of left ventricular dysfunction in the T-DXd and T-DM1 arms were as follows:

    • Any-grade: 2.9% vs 1.7%
    • Grade 1: 0.1% vs 0%
    • Grade 2: 2.5% vs 1.4%
    • Grade 3: 0.2% vs 0.4%
    • Grade 4: 0% vs 0%
    • Grade 5: 0% vs 0%

    “Adjuvant T-DXd demonstrated superior efficacy with manageable safety in patients with high-risk, HER2-positive early breast cancer and residual invasive disease after neoadjuvant therapy, which represents a potential new SOC in this post-neoadjuvant setting,” Geyer concluded.

    DISCLOSURES: Geyer reported receiving grants from or having contracts with Daiichi Sankyo, AstraZeneca, Roche/Genentech, and Exact Sciences; receiving meeting and/or travel support from Exact Sciences; receiving honoraria or travel expenses from Exact Sciences and Merck; and receiving support for the current presentation from Daiichi Sankyo and AstraZeneca.

    REFERENCES:
    1. Geyer CE, Park YH, Shao Z, et al. Trastuzumab deruxtecan (T-DXd) vs trastuzumab emtansine (T-DM1) in patients (pts) with high-risk human epidermal growth factor receptor 2–positive (HER2+) primary breast cancer (BC) with residual invasive disease after neoadjuvant therapy (tx): interim analysis of DESTINY-Breast05. Presented at: 2025 ESMO Congress; October 17-21, 2025; Berlin, Germany. Abstract LBA1.
    2. Kadcyla. Prescribing information. Genentech; revised May 2025. Accessed October 18, 2025. https://www.gene.com/download/pdf/kadcyla_prescribing.pdf

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  • Invikafusp Alfa Boasts High Disease Control Rate in Checkpoint Inhibitor–Resistant Solid Tumors

    Invikafusp Alfa Boasts High Disease Control Rate in Checkpoint Inhibitor–Resistant Solid Tumors

    Invikafusp alfa led to tumor regression in target lesions in 52% of patients with tumor mutational burden–high (TMB-H) or microsatellite instability–high (MSI-H) solid tumors resistant to immune checkpoint blockade, according to data from the phase 2 START-001 trial (NCT05592626) presented at the 2025 ESMO Congress.1

    Across the 4 biomarker-enriched populations with TMB-H tumors, TMB-H gastrointestinal cancers, TMB-H metastatic colorectal cancer (mCRC), and MSI-H tumors, the objective response rates (ORRs) were 20.5% (n = 9 of 44), 27.8% (n = 5 of 18), 33.3% (n = 3 of 9), and 30% (n = 3 of 10), respectively. The respective disease control rates were 79.5% (n = 35 of 44), 77.8% (n = 14 of 18), 66.7% (n = 6 of 9), and 70% (n = 7 of 10). Notably, the TMB-H cohort included patients with CRC, gastric, lung, breast, and other cancers.

    “Invikafusp alfa, a first-in-class bispecific dual T-cell agonist, demonstrated clinically meaningful monotherapy activity in heavily pretreated immune checkpoint blockade–resistant/insensitive tumors harboring high tumor mutations,” presenting study author Antoine Italiano, MD, PhD, professor of medicine, head of Early Phase Trials Unit at the Institut Bergonié, and head of Precision Medicine at Gustave Roussy in France, stated in the presentation.

    What Was the Study Rationale?

    Immunotherapy resistance poses a clinical challenge as it limits the number of effective treatment options that are available to patients. Tumor-infiltrating lymphocyte therapies have shown promise in the immuno-oncology (IO)–refractory setting, with Vβ6/10 T-cell subsets representing the most common subset.

    Invikafusp alfa was designed to selectively activate and expand Vβ10 T-cell subsets to overcome resistance to immune checkpoint blockade.

    What Were the Enrollment Criteria?

    Eligibility criteria required that patients have unresectable, locally advanced or metastatic, TMB-H, MSI-H, or virally-associated solid tumors in phase 1, and TMB-H, MSI-H/mismatch repair–deficient (dMMR) tumors, including TMB-H and/or MSI-H CRC in phase 2.2 An ECOG performance status of 0 or 1 was required in both phases. Prior treatment with PD-(L)1 inhibition was allowed. In phase 2, patients with hepatic metastases were not permitted unless they had been treated and were stable.

    Phase 1 followed a traditional dose-escalation design in which patients received either 0.01 mg/kg, 0.02 mg/kg, 0.04 mg/kg, 0.08 mg/kg, 0.12 mg/kg, or 0.16 mg/kg of invikafusp alfa.1 The dose expansion phase was broken into 3 cohorts: TMB-H (n = 56; cohort 1), MSI-H/dMMR (n = 29), and TMB-H and/or MSI-H/dMMR mCRC (n = 23 to 56). In phase 2, all patients received the recommended phase 2 dose (RP2D) of 0.08 mg/kg of the agent intravenously every 2 weeks.

    The primary objective of phase 1 was to determine the RP2D and evaluate the safety and tolerability of the regimen. ORR per immune RECIST criteria served as the primary objective of phase 2.

    What Patient Characteristics Were Presented?

    As of July 9, 2025, 55 patients with TMB-H/MSI-H tumors had been enrolled in phase 2, adding to the 8 that had been enrolled in phase 1 at the optimal biologic dose. Represented tumor types (n = 63) included CRC (25.4%), non–small cell lung cancer (14.3%), head and neck squamous cell carcinoma (7.9%), gastric cancer (6.3%), breast cancer (4.8%), cutaneous cancer (4.8%), endometrial cancer (4.8%), melanoma (4.8%), anal cancer (3.2%), basal cell carcinoma (3.2%), gastroesophageal junction cancer (3.2%), pancreatic cancer (3.2%), bladder cancer (1.6%), cervical cancer (1.6%), duodenal adenocarcinoma (1.6%), esophageal cancer (1.6%), neuroendocrine carcinoma cells (1.6%), ovarian cancer (1.6%), prostate cancer (1.6%), thymic cancer (1.6%), and thyroid cancer (1.6%).

    The median age was 61 (range, 53-69) and most patients were male (95.2%), White (63.5%), and had an ECOG performance status of 1 (52.8%). Most patients received between 1 and 3 prior lines of therapy (65.1%), prior treatment with an immune checkpoint inhibitor (67%), and had TMB-H disease (73.0%). Best response to prior immunotherapy was largely split between partial response (30.1%), stable disease (16.7%), progressive disease (26.2%), and unknown (26.2%).

    Was the Agent’s Mechanism of Action Indicative of Its Safety Profile?

    Italiano noted that the safety profile was consistent with the agent’s mechanism of action. The most common treatment-related adverse effects (TRAEs) were cytokine release syndrome (grade 1, 22.2%; grade 2, 46.0%; grade 3, 12.7%), rash (grade 1, 11.1%; grade 2, 34.9%; grade 3, 7.9%), nausea (grade 1, 28.6%; grade 2, 20.6%; grade 3, 1.6%), pruritus (grade 1, 22.2%; grade 2, 20.6%; grade 3, 6.3%), vomiting (grade 1, 17.5%; grade 2, 31.7%; grade 3, 0%), alanine aminotransferase increase (grade 1, 22.2%; grade 2, 4.8%; grade 3, 9.5%), platelet count decrease (grade 1, 11.1%; grade 2, 12.7%; grade 3, 12.7%), chills (grade 1, 15.9%; grade 2, 11.1%; grade 3, 0%), diarrhea (grade 1, 19.0%; grade 2, 6.3%; grade 3, 1.6%), peripheral edema (grade 1, 9.5%; grade 2, 7.9%; grade 3, 0%), and increased blood bilirubin (grade 1, 7.9%; grade 2, 4.8%; grade 3, 3.2%).

    “No step-up dosing and no immune checkpoint inhibitor–type immune-related adverse effects were reported. TRAEs were on target and well managed with supportive care, including corticosteroids such as tocilizumab (Actemra),” Italiano said.

    What Are the Key Takeaways From This Presentation?

    “Selective activation of the T-cell Vβ repertoire represents a novel class of IO bispecific therapy, with broad potential as a next generation T-cell–targeted multi-specific antibody platform for the advancement of precision immunotherapy,” Italiano concluded.

    Disclosures: No disclosures were presented for Italiano.

    References

    1. Garralda E, Italiano A, Marabelle A, et al. START-001: initial phase 2 clinical activity of invikafusp alfa, a first-in-class T cell receptor (TCR) β-chain-targeted bispecific antibody as monotherapy in patients with antigen-rich solid tumors resistant to immune checkpoint blockade (ICB). Presented at: 2025 ESMO Congress; October 17-21, 2025; Berlin, Germany. Abstract LBA55.
    2. A study of a selective T cell receptor (TCR) targeting, bifunctional antibody-fusion molecule STAR0602 in participants with advanced solid tumors (START-001). Clinicaltrials.gov. Updated July 9, 2025. Accessed October 18, 2025. https://clinicaltrials.gov/study/NCT05592626

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  • Evaluating Valuation After Ignite AI Advisor Launch and Major Industry Changes

    Evaluating Valuation After Ignite AI Advisor Launch and Major Industry Changes

    Equifax (EFX) has rolled out its new Ignite AI Advisor platform, which brings lender-focused analytics and generative AI capabilities to the forefront. This launch comes at a time of industry shifts, including changes to credit scoring access that could affect future revenue.

    See our latest analysis for Equifax.

    Despite Equifax’s ongoing push into AI-powered products for lenders, the company’s recent developments arrive amid shifting industry dynamics and competitive pressures. Over the past year, shareholders have faced a total return decline of nearly 19%, while the share price has fallen almost 10% year-to-date. This serves as a reminder that sentiment has faded even as management pursues new growth avenues. Meanwhile, three- and five-year total shareholder returns remain solidly positive, suggesting longer-term investors have still come out ahead.

    If you’re interested in uncovering what else is gaining momentum beyond the headlines, this is a great time to expand your search and discover fast growing stocks with high insider ownership

    Given recent innovations and ongoing industry disruptions, the key question for investors is whether Equifax’s current valuation still leaves room for upside, or if the market is already pricing in the company’s growth prospects.

    Equifax’s most widely followed fair value narrative puts the company’s worth at $277.70 per share, notably above the last close price of $226.91. This suggests that, according to current consensus, the market is not yet pricing in all the drivers that underpin the long-term outlook.

    “Accelerating customer adoption of new multi-data product solutions (e.g., TWN indicator, Single Data Fabric, EFX.AI) and continued high NPI (New Product Introduction) rates are expanding Equifax’s value proposition and positioning the company to capture incremental market share and drive sustained organic revenue growth above historical levels. Structural expansion of government verification requirements (e.g., semiannual redeterminations, added work requirements, improper payment focus) and a rising TAM for eligibility verification services are set to benefit long-term revenue growth and reduce business cyclicality as Equifax’s solutions become more critical to federal and state programs.”

    Read the complete narrative.

    Curious what’s behind that premium price? The secret sauce is in the projected pace of revenue expansion, ambitious margin targets, and a future earnings multiple seldom seen in the industry. Want to see which bullish financial levers drive this fair value? Click through for the complete playbook; your next big insight could be one number away.

    Result: Fair Value of $277.70 (UNDERVALUED)

    Have a read of the narrative in full and understand what’s behind the forecasts.

    However, ongoing legal costs and fresh regulatory uncertainty may cloud the earnings outlook and challenge Equifax’s momentum over the next few years.

    Find out about the key risks to this Equifax narrative.

    While the analyst consensus sees Equifax as undervalued based on future earnings growth and price targets, price-based metrics tell a different story. The shares trade at about 43.9 times earnings, which is much higher than both its industry peers and the market’s fair ratio of 34.8. This premium suggests investors are already paying up for expected growth, increasing the risk if those expectations fall short. Could this gap be a warning sign or an opportunity in disguise?

    See what the numbers say about this price — find out in our valuation breakdown.

    NYSE:EFX PE Ratio as at Oct 2025

    If you think there’s another side to this story, or want to dive deeper yourself, building your own data-driven narrative takes just a few minutes. Do it your way

    A great starting point for your Equifax research is our analysis highlighting 4 key rewards and 1 important warning sign that could impact your investment decision.

    Smart investors know opportunities go far beyond just one company, so don’t limit yourself. Explore unique market trends and sharpen your edge today.

    This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

    Companies discussed in this article include EFX.

    Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team@simplywallst.com

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  • Tarlatamab Improves OS vs Chemotherapy in SCLC, Regardless of Prior PD-(L)1 Therapy or CFI Duration

    Tarlatamab Improves OS vs Chemotherapy in SCLC, Regardless of Prior PD-(L)1 Therapy or CFI Duration

    Tarlatamab-dlle (Imdelltra) demonstrated a significant overall survival (OS) advantage over standard chemotherapy in patients with small cell lung cancer (SCLC), irrespective of chemotherapy-free interval (CFI) duration or prior anti–PD-(L)1 therapy, according to results from the phase 3 DeLLphi-304 trial (NCT05740566) presented at the 2025 ESMO Congress.

    The median OS was 10.9 months in the tarlatamab arm vs 6.4 months in the chemotherapy arm among patients with a CFI of less than 90 days (HR, 0.60; 95% CI, 0.43-0.84). The 12-month OS rates in this population were 40% vs 24% with tarlatamab and chemotherapy, respectively.

    Among patients with a CFI of 90 days or longer, the median OS was 17.1 months compared with 10.6 months in each arm, with respective 12-month OS rates of 64% and 48% (HR, 0.65; 95% CI, 0.45-0.93). Regarding patients with disease progression within 2 weeks of their most recent platinum-containing treatment, the Kaplan-Meier estimated 6-month OS rates were 55% with tarlatamab and 35% with chemotherapy.

    Among patients with prior receipt of anti–PD-(L)1 agents, the median OS was 14.1 months in the tarlatamab arm and 8.3 months in the chemotherapy arm; the respective 12-month OS rates were 53% vs 36% (HR, 0.61; 95% CI, 0.45-0.82). In the group of patients without prior anti–PD-(L)1 therapy, the median OS was 13.6 months vs 8.3 months, and the 12-month OS rates were 53% vs 40% (HR, 0.65; 95% CI, 0.42-1.03). Overall, data showed that prior exposure to anti–PD-(L)1 agents did not affect OS benefits with tarlatamab vs chemotherapy.

    “In the second line, standard chemotherapies have demonstrated modest survival benefits, especially [in] those patients with platinum-resistant disease, [who] often have a poor prognosis. DeLLphi-304 is the first randomized phase 3 trial to demonstrate superior OS with tarlatamab compared with standard chemotherapy. Importantly, this survival benefit extended to patients with platinum-resistant disease,” presenting author Pedro F. Simoes da Rocha, MD, PhD, of Vall d’Hebron University Hospital and Vall d’Hebron Institute of Oncology in Barcelona, Spain, stated in the presentation.1 “These findings reinforce the use of tarlatamab as a standard of care in second-line SCLC, including those patients with worse prognosis, such as [those] with platinum-resistant disease.”

    In the randomized DeLLphi-304 trial, 509 patients were assigned 1:1 to receive tarlatamab (n = 254) or investigator’s choice of chemotherapy (n = 255), which included options of topotecan (n = 185), lurbinectedin (Zepzelca; n = 47), and amrubicin (n = 23). Investigators stratified patients by prior receipt of anti–PD-(L)1 agents, CFI interval, presence of brain metastases, and intended chemotherapy.

    The trial’s primary end point was OS. Secondary end points included progression-free survival, patient-reported outcomes, objective response rate, and safety.

    Patients with histologically or cytologically confirmed SCLC, disease progression following frontline platinum-based chemotherapy with or without anti–PD-(L)1 therapy, and an ECOG performance status of 0 or 1 were eligible for enrollment on the trial. Those with asymptomatic, treated, or untreated brain metastases were able to enroll.

    In the tarlatamab and chemotherapy arms, respectively, 43% and 45% of patients had a CFI of less than 90 days, and 57% and 55% had a CFI of 90 days or longer. Additionally, 71% of patients in both arms had prior receipt of anti–PD-(L)1 therapy, while 29% from both arms did not. Investigators noted that subgroup baseline characteristics appeared to be balanced between treatment arms.

    Across the different CFI and anti–PD-(L)1 subgroups, rates of grade 3 or higher treatment-related adverse effects (AEs) ranged from 24% to 30% in the tarlatamab arm and 58% to 69% in the chemotherapy arm. Any-grade events of cytokine release syndrome (CRS) occurred in 51% to 59% of patients who received tarlatamab across various subgroups, and subgroup status did not impact the risk of CRS.

    Previously, the FDA granted accelerated approval to tarlatamab as a treatment for patients with extensive-stage SCLC following progression on prior platinum-based chemotherapy in May 2024.2 Supporting data for this indication came from the phase 2 DELLphi-301 trial (NCT05060016).

    References

    1. Rocha P, Sun L, Cho BC, et al. Tarlatamab as second-line (2L) treatment for small cell lung cancer (SCLC): Outcomes by chemotherapy-free interval (CFI) and prior PD-(L)1 inhibitor use in the phase 3 DeLLphi-304 trial. Presented at the European Society for Medical Oncology (ESMO) Congress 2025; October 17-21, 2025; Berlin, Germany. LBA101.
    2. FDA grants accelerated approval to tarlatamab-dlle for extensive stage small cell lung cancer. News release. FDA. May 16, 2024. Accessed October 18, 2024. https://tinyurl.com/48k34rw5

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  • Pembrolizumab Plus Paclitaxel +/– Bevacizumab Yields Survival Advantages in Recurrent PROC

    Pembrolizumab Plus Paclitaxel +/– Bevacizumab Yields Survival Advantages in Recurrent PROC

    The combination of pembrolizumab (Keytruda) plus weekly paclitaxel with or without bevacizumab (Avastin) generated a statistically significant progression-free survival (PFS) benefit vs placebo plus paclitaxel with or without bevacizumab regardless of PD-L1 status, as well as an overall survival (OS) benefit, in patients with recurrent, PD-L1–expressing platinum-resistant ovarian cancer (PROC), according to data from the phase 3 ENGOT-ov65/KEYNOTE-B96 trial (NCT05116189) presented at the 2025 ESMO Congress.

    The analysis was broken down between the population of patients with a combined positive score (CPS) of 1 or higher and the intention-to-treat population. Furthermore, data were broken down between interim analysis 1 (IA1), which had a data cutoff date of April 3, 2024, and interim analysis 2 (IA2), which had a data cutoff date of May 5, 2025.

    The CPS of 1 or Higher Population

    At IA1, the median PFS was 8.3 months (95% CI, 7.0-9.4) in the pembrolizumab arm compared with 7.2 months (95% CI, 6.2-8.1) in the placebo arm, with 12-month PFS rates of 35.2% (95% CI, 28.8%-41.7%) vs 22.6% (95% CI, 17.0%-28.7%), respectively (HR, 0.72; 95% CI, 0.58-0.89; P = .0014).

    At IA2, the median PFS was 8.3 months in the pembrolizumab arm compared with 7.2 months in the placebo arm (HR, 0.75; 95% CI, 0.61-0.91); the 12-month PFS rates were 35.9% vs 23.9%, respectively, and the 18-month rates were 18.7% vs 10.5%.

    The median OS was 18.2 months (95% CI, 15.3-21.0) in the pembrolizumab arm compared with 14.0 months (95% CI, 12.5-16.1) in the placebo arm, with 12-month OS rates of 69.1% vs 59.3%, and 18-month OS rates of 51.5% vs 38.9%, respectively (HR, 0.76; 95% CI, 0.61-0.94; P = .0053).

    The objective response rate (ORR) was 53.0% (95% CI, 45.8%-60.0%), with a complete response (CR) rate of 9.9% and a partial response (PR) rate of 43.1%, in the pembrolizumab arm; in the placebo arm, the ORR was 46.6% (95% CI, 39.6%-53.7%), with a CR rate of 7.8% and a PR rate of 38.7%. The 12- and 18-month duration of response (DOR) rates in the pembrolizumab arm were 46.7% and 28.4% compared with 29.6% and 16.4% in the placebo arm.

    The ITT Population

    At IA1, the median PFS was 8.3 months (95% CI, 7.2-8.6) with pembrolizumab compared with 6.4 months (95% CI, 6.2-8.1) with placebo, with 12-month PFS rates of 33.1% (95% CI, 27.7%-38.5%) and 21.3% (95% CI, 16.6%-26.4%), respectively (HR, 0.70; 95% CI, 0.58-0.84; P <.0001).

    At IA2, the median PFS was 8.3 months vs 6.4 months, respectively (HR, 0.73; 95% CI, 0.62-0.86); the 12-month PFS rates were 33.7% vs 22.5%, and the 18-month PFS rates were 17.3% vs 9.0%.

    The ORR was 50.4% (95% CI, 44.3%-56.4%), with a CR rate of 8.3% and a PR rate of 42.0%, in the pembrolizumab arm; in the placebo arm, the ORR was 40.8% (95% CI, 35.0%-46.8%), with a CR rate of 6.0% and a PR rate of 34.8%.Furthermore, the 12- and 18-month DOR rates in the pembrolizumab arm were 46.6% and 26.5% compared with 28.4% and 14.5% in the placebo arm.

    “These data support the use of pembrolizumab plus weekly paclitaxel, with or without bevacizumab, as a new standard of care for patients with [recurrent] PROC,” presenting author Nicoletta Colombo, MD, PhD, of the Gynecologic Oncology Program at the European Institute of Oncology, IRCCS, in Milan, Italy, and the Department of Medicine and Surgery at the University of Milan-Bicocca in Italy, wrote with coauthors in the presentation.

    Safety Analyses

    Any-grade treatment-related adverse events (TRAEs) occurred in 97.8% of the pembrolizumab arm and 95.3% of the placebo arm; grade 3 or higher TRAEs occurred in 67.5% and 55.3%, respectively. TRAEs were serious in 33.1% and 19.5%, led to death in 0.9% and 1.6%, and led to discontinuation of any treatment in 35.9% and 28.0%.

    Any-grade immune-mediated AEs occurred in 39.1% and 18.9%, and grade 3 or higher events occurred in 11.6% and 3.5%. They were serious events in 10.9% and 2.2%, and led to treatment discontinuation in 6.9% and 2.5%.

    The most common TRAEs in both groups included anemia (49.7% vs 42.1%, respectively), peripheral neuropathy (38.8% vs 31.1%), alopecia (37.8% vs 34.0%), fatigue (35.3% vs 33.0%), and nausea (31.3% vs 27.4%). The most common immune-mediated AEs were hypothyroidism (17.8% vs 6.0%), infusion reactions (5.9% vs 4.7%), and hyperthyroidism (5.0% vs 0.6%).

    Trial Breakdown

    A total of 643 patients with histologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal carcinoma were enrolled in the trial and randomly assigned to either the pembrolizumab arm (n = 322) or the placebo arm (n = 321). Treatment was either pembrolizumab at 400 mg once every 6 weeks for 18 cycles or placebo on the same schedule; all patients received paclitaxel at 80 mg/m2 on days 1, 8, and 15 of each 3-week-long cycle, and they either did or did not receive bevacizumab at 10 mg/kg every 2 weeks.

    Patients were enrolled in the trial if they had received 1 or 2 prior lines of therapy with at least 1 platinum-based chemotherapy; prior anti-PD-1 or anti-PD-L1 agents, PARP inhibitors, and bevacizumab were permitted. Additionally, patients had radiographic progression within 6 months after the last dose of platinum-based chemotherapy and an ECOG performance status of 0 or 1.

    The primary end point of the trial was PFS per RECIST v1.1 by investigator assessment, and a key secondary end point was OS.

    The median age of patients was 62 years vs 61 years in the pembrolizumab vs placebo arm, 64.3% and 67.6% of patients were White, 41.3% and 41.1% had a PD-L1 CPS from 1 to less than 10, and 31.4% and 31.2% had a PD-L1 CPS of at least 10.

    Reference

    Colombo N, Zsiros E, Sebastianelli A, et al. Pembrolizumab vs placebo plus weekly paclitaxel ± bevacizumab in platinum-resistant recurrent ovarian cancer: Results from the randomized double-blind phase 3 ENGOT-ov65/KEYNOTE-B96 study. Presented at: European Society of Medical Oncology Congress 2025; October 17–20, 2025; Berlin, Germany. Abstract LBA3.

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  • ‘I lost 25 pounds in 20 days’: what it’s like to be on the frontline of a global cyber-attack | Cybercrime

    ‘I lost 25 pounds in 20 days’: what it’s like to be on the frontline of a global cyber-attack | Cybercrime

    Tim Brown will remember 12 December 2020 for ever.

    It was the day the software company SolarWinds was notified it had been hacked by Russia.

    Brown, the chief information security officer at SolarWinds, immediately understood the implications: any of the company’s more than 300,000 global clients could be affected too.

    The exploit allowed the hackers remote access to the systems of customers that had installed SolarWinds’ network software Orion, including the US treasury department, the US department of commerce’s National Telecommunications and Information Administration, along with thousands of companies and public institutions.

    Brown says he was “running on adrenaline” in the first few days after the attack.

    It was during the early stages of the Covid pandemic when full-time work-from-home was the norm, but the company’s email was compromised and couldn’t be used to communicate with staff.

    “We gave up on the phones and just everybody came into the office and we got Covid testing,” Brown says. “I lost 25 pounds in about 20 days … just going, going, going.”

    He appeared on CNN and 60 Minutes, and in every major newspaper.

    “The world’s on fire. You’re trying to get information out and trying to have people understand what’s safe and what’s not safe.”

    The company switched to Proton email and Signal while its email was compromised, Brown says. He was taking calls from companies and government agencies across the globe, including the US army and the Covid vaccine program Operation Warp Speed.

    “You get the world wanting verbal communication not written communication. And that is a kind of an important lesson: you can write things down, but they want to talk to the [chief information security officer],” says Brown, who spoke at Melbourne’s CyberCon on Friday.

    “They want to be able to hear colour around the outside of it, so very important to be prepared for that kind of response.”

    How the cyber-attack unfolded

    The notification about the hack came in a phone call from Kevin Mandia, the founder of the cybersecurity firm Mandiant, to SolarWinds’ then CEO Kevin Thompson.

    Mandia told Thompson that SolarWinds had “shipped tainted code” to its Orion software, which helps organisations monitor outages on their computer networks and servers.

    The exploit in Orion was being used to attack government agencies, Mandia told Thompson.

    “We could see in that code [it] was not ours, so when we got that, it was ‘all right, this is real’,” Brown recalls.

    Brown says SolarWinds was not the key target of the hack but ‘a route to the target’. Photograph: Sean Davey/The Guardian

    The Texas-based SolarWinds determined that 18,000 people had downloaded the tainted product, which the hackers, later attributed to the Russian Foreign Intelligence Service, were able to insert into Orion in the build environment where source code is turned into software.

    The news broke on the Sunday. SolarWinds notified the stock market before it opened on Monday.

    The original estimate that up to 18,000 clients could be affected was later revised down to about 100 government agencies and companies that actually were.

    “It would have been nice to know that on day one, but that was the truth of the matter, right?” Brown says. “We weren’t really the target. We were just a route to the target.”

    SolarWinds called in CrowdStrike, KPMG and the law firm DLA Piper to deal with the response and investigation.

    Aftermath: the heart attack

    SolarWinds stopped work on new features for the next six months and its team of 400 engineers focused on systems and security to get the company back on its feet.

    “We really took transparency to heart – how can we make sure people realise [what] threat actor models [are out there], what they do, how they do reconnaissance, how they then do an attack [and] how they then leave.”

    Brown says the company’s customer renewal rate fell into the 80% range in the first few months after the incident, but has since returned to more than 98%.

    But then came the legal implications.

    The Biden administration imposed sanctions and expelled Russian diplomats in 2021, partly in response to the attack.

    SolarWinds settled a class action lawsuit over the attack in 2022 for US$26m. The Securities and Exchange Commission (SEC) then filed a lawsuit against SolarWinds and Brown personally in October 2023, accusing the company and Brown of misleading investors over its claims about cybersecurity protections, and failing to disclose known vulnerabilities.

    Brown has remained at SolarWinds since the cyber-attack. Photograph: Sean Davey/The Guardian

    Brown was in Zurich when he found out he was being charged.

    “When I walked up a hill, I would lose my breath. My arms would get heavy, my chest would get tight. I was just not getting enough oxygen,” he says. “I did a silly thing. I flew home … I couldn’t walk from the terminal to my car without stopping. That’s a walk I had done thousand of times.”

    He was having a heart attack. When he got home, his wife took him to the hospital, where he underwent surgery. He has since recovered.

    “Stress keeps building up and I thought I was managing it well and I didn’t proactively go to a doctor,” he says.

    Brown says he now advocates for companies going through similar incidents to employ psychiatrists to help staff process the stress.

    “The stress level was pumped up, and then it just went over the edge, but stress was building up all the time.”

    A confidential jointly proposed settlement with the SEC was announced in July, but has yet to be approved. The US government shutdown has delayed the finalisation of the agreement.

    Brown has remained with SolarWinds throughout the process.

    “It happened on my watch, that’s how I look at it. There are reasons why it occurred, nation state attack, et cetera, but still it happened on my watch,” he says.

    “I guess I’m stubborn. But it was just very important for us to get through this whole cycle, so leaving wasn’t an option until it was done.”

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  • Wikipedia says traffic is falling due to AI search summaries and social video

    Wikipedia says traffic is falling due to AI search summaries and social video

    Wikipedia is often described as the last good website on an internet increasingly filled with toxic social media and AI slop. But it seems the online encyclopedia is not completely immune to broader trends, with human pageviews falling 8% year-over-year, according to a new blog post from Marshall Miller of the Wikimedia Foundation.

    The foundation works to distinguish between traffic from humans and bots, and Miller writes that the decline “over the past few months” was revealed after an update to Wikipedia’s bot detection systems appeared to show that “much of the unusually high traffic for the period of May and June was coming from bots that were built to evade detection.”

    Why is traffic falling? Miller points to “the impact of generative AI and social media on how people seek information,” particularly as “search engines are increasingly using generative AI to provide answers directly to searchers rather than linking to sites like ours” and as “younger generations are seeking information on social video platforms rather than the open web.” (Google has disputed the claim that AI summaries reduce traffic from search.)

    Miller says the foundation welcomes “new ways for people to gain knowledge” and argues this doesn’t make Wikipedia any less important, since knowledge sourced from the encyclopedia is still reaching people even if they don’t visit the website. Wikipedia even experimented with AI summaries of its own, though it paused the effort after editors complained.

    But this shift does present risks, particularly if people are becoming less aware of where their information actually comes from. As Miller puts it, “With fewer visits to Wikipedia, fewer volunteers may grow and enrich the content, and fewer individual donors may support this work.” (Some of those volunteers are truly remarkable, reportedly disarming a gunman at a Wikipedia editors’ conference on Friday.)

    For that reason, he argues that AI, search, and social companies using content from Wikipedia “must encourage more visitors” to the website itself.

    And he says Wikipedia is taking steps of its own, for example by developing a new framework for attributing content from the encyclopedia. The organization also has two teams tasked with helping Wikipedia reach new readers, and it’s looking for volunteers to help.

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    Miller also encourages readers to “support content integrity and content creation” more broadly.

    “When you search for information online, look for citations and click through to the original source material,” he writes. “Talk with the people you know about the importance of trusted, human curated knowledge, and help them understand that the content underlying generative AI was created by real people who deserve their support.”

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  • Reliance Industries Ltd (WBO:RLI) Q2 2026 Earnings Call Highlights: Strong Growth Across …

    Reliance Industries Ltd (WBO:RLI) Q2 2026 Earnings Call Highlights: Strong Growth Across …

    This article first appeared on GuruFocus.

    Release Date: October 17, 2025

    For the complete transcript of the earnings call, please refer to the full earnings call transcript.

    • Reliance Industries Ltd (WBO:RLI) reported strong performance across all business segments, with a notable 18% growth in EBITDA for Jio, driven by strong customer additions in both mobility and home segments.

    • The retail segment saw a robust year-on-year growth of 17% in EBITDA, with revenues increasing by 18%, supported by significant growth in fashion, lifestyle, grocery, and electronics categories.

    • The energy business reported a 21% increase in performance, driven by higher cracks across gasoline, gas oil, and ATF, along with increased domestic placements.

    • Reliance Industries Ltd (WBO:RLI) is making significant progress in its new energy initiatives, with plans to start renewable energy round-the-clock power plants in Kutch next year.

    • The company is expanding its digital services and AI capabilities, with Reliance Intelligence set to develop AI products and solutions, leveraging partnerships with global tech companies like Meta.

    • Despite strong overall performance, the upstream segment experienced a decline due to natural production falls in the KGD6 fields.

    • Finance costs increased by 14%, and depreciation rose by 12%, primarily due to 5G capitalization and spectrum interest.

    • The petrochemical segment faced challenges with weak demand for PVC and PET due to heavy rains and floods affecting agricultural and packaging sectors.

    • The media business, while showing growth, faces challenges in maintaining momentum post-IPL, with a need to convert cricket audiences to entertainment content.

    • The geopolitical situation and increased OSPs have impacted the refining margins, despite high cracks in the refining segment.

    Q: Are there any plans for a tariff hike in the near future? A: Unidentified_2: No immediate plans for a tariff hike. We are encouraging consumers to use more services, but there are no current plans to change tariffs.

    Q: Is the current monthly run rate for connecting new homes expected to increase? A: Unidentified_2: We expect to ramp up the rate of connecting new homes. The technology is working well, and many new connections are being done wirelessly, allowing for simpler and faster implementation.

    Q: How will Reliance Intelligence and Geo Platforms collaborate on AI initiatives? A: Unidentified_2: Reliance Intelligence will develop AI products and solutions, while Geo Platforms will bring these to market. Geo Platforms can also work with other partners like Meta, OpenAI, and Google.

    Q: What is the status of the battery cell assembly plant, and how is Reliance handling equipment sourcing given China’s export restrictions? A: Unidentified_8: The battery cell factories are progressing well, and we have secured all equipment for the first phase of cell manufacturing. Equipment sourcing is happening globally, and we are monitoring the impact of new regulations.

    Q: How is the Quick commerce model different from other models, and what advantages does it offer? A: Unidentified_3: The Quick commerce model has pivoted to focus on instant deliveries, offering the widest assortment, best pricing, and no hidden charges. The model leverages a vast store network and localized assortment knowledge, providing a significant advantage over competitors.

    For the complete transcript of the earnings call, please refer to the full earnings call transcript.

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