Category: 3. Business

  • Cycling fashion group Rapha prepares for long climb back to profit

    Cycling fashion group Rapha prepares for long climb back to profit

    Rapha, the high-end British cycling fashion brand whose rapid ascent came crashing to a halt with the end of the pandemic bike boom, is gearing up for a long ride back to profit.

    Industry veteran Fran Millar, who became the fourth chief executive in three years when she took charge in September 2024, says her turnaround of the maker of £300 cycling jerseys will take until 2027 to show full results. 

    “The decisions we’re taking now are things that are going to bounce” Rapha back to “not just profitability but significant growth”, Millar told the Financial Times.

    Founded in 2004 by cycling enthusiast and branding expert Simon Mottram, Rapha quickly rose to become one of the biggest names in cycling fashion, known for minimalist designs, high quality and attention to detail.

    But annual revenues dropped 13 per cent to £96.2mn in the year to the end of January while the company made a net loss — its eighth in a row — of £15.6mn, according to results due to be published next week. Meanwhile, holding company Carpegna took a £102mn impairment on the brand’s book value, a writedown of more than 60 per cent. 

    Millar, who was hired from fashion brand Belstaff and has previously run the Team Sky and Ineos Grenadiers professional cycling teams, insists the company can return to a “market pioneering” position after the sharp fall in revenue to a five-year low.

    Her plan is to “reduce the losses next year and by 2027 we will be back at profitability” at an Ebitda level.

    Rapha’s latest gloomy numbers show that even the biggest names in cycling are still struggling with the pandemic boom and bust, when a sharp rise in the popularity of cycling during lockdowns was followed by a sudden stop.

    With 50 per cent year-on-year revenue growth for more than a decade to 2021, the brand “was the Apple of cycling”, former professional cyclist Anthony Walsh said in June in his Roadman podcast, with cyclists wearing its kit as “badges of honour”. 

    In 2017, Mottram sold a majority stake to RZC Investments — an investment vehicle owned by brothers Steuart and Tom Walton, cycling enthusiast grandsons of Walmart founder Sam Walton — in a deal that valued Rapha at about £200mn.

    While Walsh claimed the change in ownership was one cause of Rapha’s problems, Millar rejected that idea, insisting “we’re very lucky in our owners”, who she said took a long-term view. RZC this year provided £15mn in additional capital, following an earlier £39mn debt-to-equity swap.

    “The amazing growth in the pandemic probably masked some things that should have been addressed earlier,” Millar said, adding that “a lot of the damage was self-inflicted”.

    When new rivals including Café du Cycliste and Pas Normal Studios started to target fashion-savvy cyclists, Rapha began to dabble in non-cycling gear such as hoodies and handbags. At the same time its customers started to complain about declining quality and “boring” designs.

    Rapha cycling
    The Rapha Cycling Club costs £70 a year to go on group rides and get access to exclusive kit © Rapha

    Membership numbers of the Rapha Cycling Club, where people pay £70 a year to go on group rides and have access to exclusive kit, has fallen by a third to 15,000 over the past two years. 

    Rapha “tried to do lots of things and [was] not focused on doing a few things brilliantly well”, Millar said.

    After the pandemic boom faded, the brand had a glut of stock that had to be sold at heavy discounts, which dented profitability and was “not great for the long-term health of the brand” she said.

    In her first year, Millar sought to return to a “full-price model”, saying this was the key reason for the drop in revenue last year and adding that a first success was to achieve stability in year-on-year sales of full-price kit.

    Looking forward, she is ditching the lifestyle line, pausing the production of cycling shoes and merging the brand’s two long-distance cycling ranges. And this year’s 65 product launches will shrink to roughly half that number in 2026 after a design overhaul.

    According to Millar, Rapha had come to rely too heavily on signature designs such as its armband and logo. The first of its new-look products will be unveiled in early 2026 and be available to customers from the summer.

    Rapha would not target a return to the kind of sales growth it had last decade, Millar said, adding “low double-digit profitable growth” for the next few years “would be a huge success”.

    Holding company Carpegna is set to continue to report net losses as it writes off Rapha’s intangible assets over time. This accounting treatment will not affect Rapha’s cash flows, the company said, but will reduce reported profit by about £10mn a year for a number of years.

    This year’s 65 product launches will shrink to roughly half that number in 2026 © Rapha

    Meanwhile, Millar is committed to reinvigorating the Rapha Cycling Club, which the company says is still “the biggest cycling club in the world”, and larger than it was before the pandemic. “I’ve ridden thousands of miles now with our customers all over the world, and [RCC] is just a completely unique area for us.”

    One of the most visible changes in the short term is the ending of the brand’s partnership with EF Pro Cycling, a team that participates in big races worldwide including the Tour de France.

    Instead, Millar has signed a three-year deal with USA Cycling to sponsor the country’s Olympic team, banking on the 2028 Games in Los Angeles to boost American cycling. 

    “I was involved in London 2012 and Team Sky,” she said. “And I saw what home Games can do to a nation.”

    Continue Reading

  • Large-scale manufacturing growth decelerates on flood impact – Dawn

    1. Large-scale manufacturing growth decelerates on flood impact  Dawn
    2. Pakistan’s large-scale manufacturing posts 4.44% YoY growth in July–August  Profit by Pakistan Today
    3. Pakistan’s LSM grows by 4.44pc in July–Aug  Dunya News
    4. Pakistan’s Manufacturing Sector Sees Modest Annual Growth, Monthly Decline in August  TechJuice
    5. Pakistan’s Large-Scale Manufacturing Grows 4.44% in Early FY2025  Daily Times

    Continue Reading

  • Fruquintinib Plus Sintilimab Improves PFS in Advanced RCC After First-Line VEGFR TKI Therapy

    Fruquintinib Plus Sintilimab Improves PFS in Advanced RCC After First-Line VEGFR TKI Therapy

    Treatment with fruquintinib (Fruzaqla) plus sintilimab (Tyvyt) led to a significant improvement in progression-free survival (PFS) compared with axitinib (Inlyta) or everolimus (Afinitor) in patients with advanced or metastatic renal cell carcinoma (RCC) who had progressed following prior first-line VEGFR TKI therapy, according to findings from the phase 3 FRUSICA-2 trial (NCT05522231) presented at the 2025 ESMO Congress.1

    Findings showed that at a median follow-up of 16.56 months, the blinded independent review committee (BIRC)–assessed median PFS was 22.21 months (95% CI, 16.59-not reached [NR]) with fruquintinib plus sintilimab (n = 119) vs 6.90 months (95% CI, 5.55-8.31) with axitinib or everolimus (n = 115; HR, 0.373; 95% CI, 0.256-0.544; stratified log-rank P < .0001). The 12-month PFS rate was 69.0% in the combination arm vs 34.6% in the control arm, and the 18-month PFS rates were 54.6% vs 16.9%, respectively. Investigator-assessed median PFS was consistent with these findings at 16.59 months (95% CI, 13.80-NR) with fruquintinib plus sintilimab vs 5.82 months (95% CI, 5.49-8.28) with axitinib or everolimus (HR, 0.370; 95% CI, 0.260-0.527; stratified log-rank P < .0001). The 12- and 18-month investigator-assessed PFS rates for the experimental arm were 61.6% vs 27.4%, respectively; these respective rates were 47.9% vs 10.1% in the control arm.

    “These results suggest that [fruquintinib plus sintilimab] should be a new choice for patients as second-line therapy for locally advanced and metastatic RCC,” Zhenhua Liu, MD, of West China Hospital at Sichuan University, in Chengdu, explained in the conclusion of his presentation.

    What Was the Rationale and Design of the FRUSCIA-2 Trial?

    Although TKI and immunotherapy combinations have become a standard of care in the first-line setting for patients with advanced RCC globally, Liu explained that TKI monotherapy has remained the first-line standard in China, leaving a key unmet need for patients who experience disease progression.

    The phase 3 FRUSICA-2 trial was a randomized, open-label, active-controlled study that enrolled patients between 18 and 75 years of age with histologically or cytologically confirmed locally advanced or metastatic RCC who progressed on or were intolerant to first-line VEGFR TKI therapy. Additional inclusion criteria required an ECOG performance status of 0 or 1. Patients were excluded if they had received prior immune-modulatory therapy, except in the adjuvant or neoadjuvant setting without progression within 6 months of discontinuation.

    A total of 234 patients were randomly assigned in a 1:1 ratio to receive fruquintinib plus sintilimab or axitinib or everolimus monotherapy. Patients in the experimental arm received fruquintinib at 5 mg orally once daily for 2 weeks on and 1 week off per 21-day cycle in combination with sintilimab at 200 mg intravenously once every 3 weeks. Those in the control arm received axitinib at 5 mg orally twice daily or everolimus at 10 mg orally once daily, both administered continuously in 21-day cycles.

    Treatment continued until disease progression, death, intolerable toxicity, or another protocol-specified reason for discontinuation. Stratification factors included IMDC risk classification (favorable vs intermediate vs poor) and ECOG performance status (0 vs 1).

    The primary end point was PFS by BIRC per RECIST 1.1 criteria. Secondary end points included investigator-assessed PFS, overall response rate (ORR), disease control rate (DCR), duration of response (DOR), time to response (TTR), and overall survival (OS).

    What Were the Baseline Characteristics of the Patients in the Study?

    The median age across both arms was 59.0 years (range, 36-75 in the fruquintinib plus sintilimab arm; 37-74 in the control arm). Patients 65 years of age or older accounted for 35.3% of those receiving fruquintinib plus sintilimab and 28.7% of those in the axitinib/everolimus group. Most patients were male, comprising 80.7% and 77.4% of each arm, respectively.

    With respect to ECOG performance status, 42.0% of patients in the combination arm and 40.9% in the control arm had an ECOG performance status of 0, while 58.0% and 59.1%, respectively, had a performance status of 1. Similarly, the Karnofsky Performance Status of 100 or 90 was observed in 68.9% of patients in the combination arm and 72.2% in the control arm.

    Based on IMDC risk classification, 27.7% vs 27.8% of patients were categorized as having favorable risk, 61.3% vs 62.6% as intermediate risk, and 10.9% vs 9.6% as poor risk in the fruquintinib plus sintilimab and control groups, respectively. Approximately two-thirds of patients in each group had 0 to 1 IMDC risk factors (63.9% vs 63.5%), and the remainder had two or more (36.1% vs 36.5%).

    The majority of patients (73.9% in the fruquintinib plus sintilimab arm and 58.3% in the control arm) had 2 or more organs with metastatic involvement. PD-L1 expression, defined as a combined positive score (CPS) of at least 1, was reported in 19.3% of patients receiving fruquintinib plus sintilimab and 17.4% in those treated with axitinib or everolimus, and PD-L1 CPS less than 1 was seen in 47.1% and 46.1%, respectively. The remainder had unknown PD-L1 status.

    Sarcomatoid or rhabdoid differentiation features were identified in a small subset of patients—4.2% in the fruquintinib plus sintilimab arm and 8.7% in the control arm. All patients had received prior VEGFR-targeted therapy, most commonly sunitinib (Sutent; 52.1% vs 56.5%) or pazopanib (36.1% vs 34.8%), with smaller proportions having received sorafenib (Nexavar) or axitinib. Prior nephrectomy was performed in 81.5% of patients in the fruquintinib plus sintilimab arm and 80.0% in the control arm.

    What Additional Efficacy and Response Findings Were Observed in the Trial?

    Per BIRC, the ORR was 60.5% (95% CI, 51.13%-69.34%) with fruquintinib plus sintilimab vs 24.3% (95% CI, 16.83%-33.23%) with axitinib or everolimus (odds ratio [OR], 4.622; P < .0001). The DCR was 90.8% vs 88.7%, respectively, and the median DOR was 23.69 months (95% CI, 14.46-NR) vs 11.33 months (95% CI, 6.90-NR). Median TTR was 2.79 months with fruquintinib plus sintilimab and 2.69 months with axitinib or everolimus.

    Investigator-assessed outcomes mirrored the BIRC results, with an ORR of 62.2% (95% CI, 52.84%-70.91%) for the combination vs 27.8% (95% CI, 19.87%-36.95%) for standard therapy (OR, 4.192; P < .0001). The DCR was 90.8% vs 87.8%, and the median DOR was 17.97 months (95% CI, 13.83-NR) vs 11.04 months (95% CI, 4.17-12.45).

    At the time of data cutoff, OS data reached approximately 20% maturity.

    What Safety Findings Were Observed in the Trial?

    According to Liu, the safety profile of fruquintinib plus sintilimab in the FRUSICA-2 trial was manageable and consistent with the known toxicities of VEGFR inhibitors and immune checkpoint blockade. Treatment-emergent adverse effects (TEAEs) occurred in all patients across both study arms.

    Grade 3 or higher TEAEs were reported in 71.4% of patients receiving fruquintinib plus sintilimab compared with 58.8% of those treated with axitinib or everolimus. Treatment-related AEs (TRAEs) occurred in 100% of patients in the fruquintinib plus sintilimab arm and in 99.1% of those in the control arm, with grade 3 or higher TRAEs observed in 59.7% and 48.2% of patients, respectively. Serious TEAEs were more frequent in the combination group (48.7%) than in the control group (29.8%).

    Immune-related AEs (irAEs), assessed by investigators, were reported in 63.0% of patients in the fruquintinib plus sintilimab arm, with 27.7% experiencing grade 3 or higher effects. Infusion-related reactions (IRRs) occurred in 1.7% of patients treated with the combination regimen.

    The most common TEAEs reported in at least 20% of patients in either group included proteinuria, hypothyroidism, palmar-plantar erythrodysesthesia syndrome, hypertension, hypertriglyceridemia, elevated blood creatinine levels, decreased weight, asthenia, anemia, diarrhea, and elevations in liver function enzyme levels. Rates of hypothyroidism, hypertension, and proteinuria were slightly higher in the combination arm, whereas diarrhea and weight loss occurred more frequently in patients treated with axitinib or everolimus.

    China’s National Medical Products Administration is currently evaluating a new drug application seeking approval of fruquintinib with sintilimab for patients with previously treated locally advanced or metastatic RCC, supported by data from the FRUSICA-2 trial.2

    References

    1. Ye D, He Z, Qu Z, et al. Fruquintinib (FRUQ) plus sintilimab (SIN) versus axitinib (AXI) or everolimus (EVE) monotherapy as 2L treatment in pts with locally advanced or metastatic renal cell carcinoma (RCC): Results from phase III part of a randomized, open-label, active-controlled phase II/III study (FRUSICA-2). Presented at: 2025 ESMO Congress; October 17-20, 2025; Berlin, Germany. Abstract 2592MO.
    2. HUTCHMED highlights FRUSICA-2 registration trial data to be presented at the 2025 ESMO Congress. News release. HUTCHMED. October 13, 2025. Accessed October 17, 2025. https://www.hutch-med.com/esmo25-frusica2/

    Continue Reading

  • Gold crosses Rs456,000 per tola – Dawn

    1. Gold crosses Rs456,000 per tola  Dawn
    2. Gold price per tola falls Rs10,600 in Pakistan  Business Recorder
    3. Pakistan’s gold stash tops $9b on back of global rally  The Express Tribune
    4. Gold price in Pakistan for today, October 18, 2025  Profit by Pakistan Today
    5. Gold price surges to Rs 442,800/tola  Daily Times

    Continue Reading

  • PSX slips below 164,000 points on profit-taking – Dawn

    1. PSX slips below 164,000 points on profit-taking  Dawn
    2. Selling hits bourse, KSE-100 settles with over 1,200 points loss  Business Recorder
    3. PSX plummets amid cautious investor sentiment  The Express Tribune
    4. PSX experiences volatility, KSE-100 drops 638.50 points  Profit by Pakistan Today
    5. PSX Closing Bell: A Hazy Shade of Red  Mettis Global

    Continue Reading

  • U.S. court bars NSO Group from installing spyware on WhatsApp – CTV News

    U.S. court bars NSO Group from installing spyware on WhatsApp – CTV News

    1. U.S. court bars NSO Group from installing spyware on WhatsApp  CTV News
    2. US court bars Israeli spyware firm from targeting WhatsApp users  Al Jazeera
    3. US Court Bars NSO Group from Targeting WhatsApp Users  TheWire.in
    4. US court bans NSO Group from using spyware to target WhatsApp users  Scroll.in
    5. US court bars NSO Group from installing spyware on WhatsApp  France 24

    Continue Reading

  • Salesforce CEO Marc Benioff apologises for San Francisco deployment remark

    Salesforce CEO Marc Benioff apologises for San Francisco deployment remark

    Salesforce boss Marc Benioff apologised Friday for suggesting that US President Donald Trump should send National Guard troops to San Francisco.

    The apology followed days of backlash against Mr Benioff for a comment he made ahead of his company’s annual Dreamforce conference in the city.

    “Having listened closely to my fellow San Franciscans… I do not believe the National Guard is needed to address safety in San Francisco,” he said.

    The saga comes amid the Trump administration’s military deployments to US cities – many of which are led by Democrats. Trump on Friday asked the Supreme Court to overrule lower courts that blocked a National Guard deployment in Chicago.

    The mood at the usually jubilant Dreamforce convention was dampened by cancelled appearances by San Francisco Mayor Daniel Lurie, as well as comedians Kumail Nanjiani and Ilana Glazer.

    Mr Benioff was dealt public rebukes from several Democratic politicians, including California Governor Gavin Newsom, who once served as mayor of San Francisco and appeared on stage with Mr Benioff at last year’s convention.

    On Thursday, venture capitalist Ron Conway resigned from the board of the Salesforce Foundation, telling the New York Times that their values “were no longer aligned”.

    “I now barely recognize the person I have so long admired,” Conway told the newspaper.

    Although Mr Benioff walked back his comments earlier in the week, the apology posted on social media on Friday appeared aimed at putting the controversy to rest.

    “I remain deeply grateful to Mayor Lurie, SFPD, and all our partners, and am fully committed to a safer, stronger San Francisco,” Mr Benioff said in his X post.

    But he noted that his endorsement of a crackdown “came from an abundance of caution” around Dreamforce security, adding “I sincerely apologize for the concern it caused”.

    Sylvia Paull, a veteran Silicon Valley publicist, called Benioff “typical” of many tech CEOs who are not “really political animals” and tend to be transactional.

    “It was going to hurt his sales.”

    And that’s not all.

    “He’s afraid he’s going to lose his legacy,” she said of his apology.

    Mr Benioff, who also owns Time Magazine, has been a prolific donor to civic causes in San Francisco over the years.

    His name graces one of the most prominent hospitals in the San Francisco Bay Area.

    In 2018, he funded support for a San Francisco ballot measure aimed at raising corporate taxes to fund homeless services. It passed, despite controversy.

    And while he once held a fundraiser for Democratic Hillary Clinton’s 2016 presidential campaign against Mr Trump, Mr Benioff appeared with the sitting president during his state visit to London last month.

    Mr Trump said Wednesday that San Francisco was one of the next targets on his list of places where he plans to deploy the National Guard, calling the city “a mess.”

    On Friday, in an emergency appeal, the president urged the Supreme Court to permit him to deploy National Guard troops in Chicago. Lower courts have blocked the deployment there thus far, with an appeals court saying such a move would “likely to lead to civil unrest” and “only add fuel to the fire”.

    The court ruled that it had “seen no credible evidence that there has been rebellion in the state of Illinois”.

    Officials in Illinois and Chicago had sued the Trump administration to block the deployment, arguing it was a “grave intrusion on Illinois’ sovereignty”.

    The administration has recently deployed the National Guard to Portland, Oregon in a move that also prompted lawsuits and protests. It previously sent troops to Los Angeles, Washington and parts of Tennessee.

    The New York Times also reported this week that Salesforce pitched its services to the Trump administration as Immigration and Customs Enforcement (ICE) ramps up the hiring of new officers amid a crackdown on immigration.

    The BBC has reached out to Salesforce for comment.

    Trump administration official David Sacks, a Silicon Valley entrepreneur, addressed Mr Benioff in a post on X this week, writing “if the Democrats don’t want you, we would be happy for you to join our team.”

    Continue Reading

  • SBP releases Governor’s Annual Report 2024-25

    SBP releases Governor’s Annual Report 2024-25



    The State Bank of Pakistan’s (SBP) old building in Karachi. — AFP/File

    KARACHI: The share of banks financing the budget deficit fell to 74 per cent in the fiscal year that ended in June 2025 from nearly 100 per cent in FY24, resulting in a more than twofold increase in loans to private businesses, according to the central bank report released on Friday.

    Banking sector assets expanded to nearly 52.4 per cent of gross domestic product (GDP) in FY25, up from 49.1 per cent in the previous year, said Governor’s Annual Report for FY25 of the State Bank of Pakistan.

    The assets of the banking sector grew at 15.3 per cent in FY25.“The major driver of the growth in assets of the banking sector remained investments, particularly in government securities,” the SBP’s report said.

    “However, owing to lower financing needs due to fiscal consolidation, availability of the non-bank as well as external financing, the share of banks in financing the budget deficit reduced to 74 per cent in FY25, compared to almost 100 per cent in FY24,” it added.

    “In this backdrop, the private sector credit (PSC) off-take more-than- doubled during FY25, compared to FY24, as the improvement in economic activity and business confidence amid falling interest rates increased credit demand in the country.”

    In contrast to banking sector assets, the sector’s deposit growth slowed, whereas the currency-in-circulation expanded amid rising domestic uncertainty due to regional conflict, the report said.

    The disinflationary trend that began in FY24 became more pronounced during FY25. Average National CPI inflation dropped sharply to 4.5 per cent from 23.4 per cent in FY24 and 29.2 per cent in FY23, according to the report.

    The SBP said it reduced the policy rate by a cumulative 1,100 basis points (bps) between June 2024 and June 2025. However, due to lingering uncertainties — including sticky core inflation during H2-FY25, evolving global trade tariffs, rising geopolitical tensions, and volatility in administered energy prices — the Monetary Policy Committee (MPC) slowed the pace of monetary easing in the second half of FY25.

    The report noted that this measured stance facilitated a notable expansion in private sector credit and supported a gradual recovery in economic activity, especially in the latter part of the fiscal year. With the fiscal deficit narrowing to a multi-year low of 5.4 per cent of GDP, and the primary surplus more than doubling to 2.4 per cent, fiscal consolidation supplemented the monetary policy stance to help bring inflation down, the report said.

    The significant improvement in the external sector, with the current account balance (CAB) posting a surplus for the first time in over fourteen years. The CAB surplus, combined with increased financial inflows following the IMF’s Extended Fund Facility programme, enabled SBP to conduct significant foreign exchange purchases from the interbank market that strengthened foreign exchange reserves and enhanced FX market stability.

    The report highlights several measures taken by the SBP as part of its tertiary objective to support the government’s economic policy objectives. In particular, it highlights various exchange company reforms and administrative measures to boost workers’ remittances — such as enhanced incentives for banks, and targeted outreach to the diaspora — as well as measures to facilitate exporters, particularly in the IT sector, through enhanced retention limits to promote reinvestment and innovation.

    The report notes the establishment of Raast Payments Pakistan (Pvt) Ltd to oversee the operations and governance of the Raast system, the launch of the enhanced PRISM+ settlement system with integrated central securities depository features, and the introduction of a regulatory sandbox framework for payment innovation. Additionally, the SBP implemented digital payment acceptance solutions nationwide along with the further digitisation of government payments.

    Continue Reading

  • Press Briefing Transcript: IMFC, Annual Meetings 2025 – International Monetary Fund

    1. Press Briefing Transcript: IMFC, Annual Meetings 2025  International Monetary Fund
    2. IMFC Broll TV Package  IMF Media Center
    3. World Bank’s Development Committee Raises Hope Amidst Uncertainty In Global Economy  News Agency of Nigeria
    4. IMF steering committee eyes risks, hopes for more disinflation  TradingView
    5. Global Finance Chiefs Flag 3 Entrenched Risks — Trade Tensions, Geopolitical Mistrust, and AI Euphoria — Market Watch 2025  Blockchain News

    Continue Reading

  • Abemaciclib Plus Endocrine Therapy Improves Overall Survival in High-Risk Early Breast Cancer

    Abemaciclib Plus Endocrine Therapy Improves Overall Survival in High-Risk Early Breast Cancer

    Adjuvant abemaciclib (Verzenio; Eli Lilly) given alongside endocrine therapy (ET) significantly prolonged overall survival (OS), invasive disease-free survival (IDFS), and distant relapse-free survival (DRFS) in patients with hormone receptor (HR)–positive, HER2-negative, node-positive, early breast cancer in the phase 3 monarchE trial (NCT03155997).1 The results were published in Annals of Oncology and presented in a late-breaking abstract at the 2025 European Society for Medical Oncology Congress.2

    Abemaciclib is a cyclin-dependent kinase 4/6 inhibitor targeted for cancer therapy, and the monarchE trial demonstrated a 15.8% reduction in risk of death vs ET (HR, 0.84; 95% CI, 0.72-0.98; P = .027) in the intent-to-treat population at a median follow-up of 76.2 months.1 The newly published data, which make abemaciclib the first therapy in more than 2 decades to show a significant overall survival (OS) benefit in this high-risk patient population, will also be submitted to global regulatory health authorities, according to a press release.2

    “For patients, survival is what matters most—and abemaciclib plus ET represents the first contemporary medicine in over two decades to deliver a clear improvement in overall survival in the adjuvant setting,” said lead monarchE investigator Stephen Johnston, MD, PhD, professor of Breast Cancer Medicine and consultant medical oncologist at The Royal Marsden NHS Foundation Trust in London.2

    The global, open-label, randomized phase 3 trial enrolled 5637 patients with high-risk, HR-positive, HER2-negative, early-stage breast cancer from July 2017 to August 2019.1 Patients were randomly assigned 1:1 to receive standard adjuvant ET alone (n = 2829) or ET combined with abemaciclib (n = 2808). Patients received at least 5 years of ET with or without 2 years of abemaciclib (150 mg twice daily). IDFS was defined as the time from the receipt of treatment until ipsilateral invasive disease, ipsilateral locoregional invasive disease, contralateral invasive breast cancer, distant recurrence, second primary non-breast invasive cancer, or death from any cause.

    The primary OS analysis had a data cutoff of July 15, 2025, at which point there were 661 OS events—301 (10.7%) in the abemaciclib arm vs 360 (12.7%) in the ET-alone arm. At 60, 72, and 84 months, OS rates were 91.2%, 89.2%, and 86.8% in the abemaciclib plus ET arm vs 90.2%, 87.9%, and 85.0% in the ET arm. In both arms, most deaths were associated with breast cancer recurrence.

    The most frequent adverse events (AEs) leading to death were infections (including COVID-19 infections), second primary neoplasm, and cardiac disorders, and there were no relevant differences in causes of death related to AEs in either treatment group.

    Patients in the abemaciclib cohort also had a reduced risk of IDFS (HR, 0.73; 95% CI, 0.66-0.820; nominal P < .0001). The estimated IDFS rate was 83.1% in the abemaciclib plus ET arm at 5 years vs 76.5% in the ET arm; at 7 years, the estimated IDFS rates were 77.4% and 70.9%, respectively.

    “These results represent an important advancement in the care of node-positive, high-risk, HR-positive, HER2-negative disease by delivering meaningful reductions in recurrence and improving survival,” Jacob Van Naarden, executive vice president and president of Lilly Oncology, said.2

    The results are in line with prior data, with the initial IDFS analysis showing significant improvements with abemaciclib plus ET vs ET alone (HR, 0.75; 95% CI, 0.60-0.93; = .01),3 and a 5year analysis showing sustained improvements in both IDFS (HR, 0.68; 95% CI, 0.599-0.772; nominal < .001) and DRFS (HR, 0.675; 95% CI, 0.588-0.774; nominal < .001).4 At 5 years, there was a trend in OS improvement in the abemaciclib that was not yet statistically significant.

    “To now have data showing a treatment helps more people live longer is a major step forward for our community,” said Sue Weldon, CEO of Unite for HER, in the Eli Lilly press release.2 “We mark this significant milestone while recognizing there’s more work ahead to ensure every eligible patient has the opportunity to benefit from treatments that can change lives.”

    References

    1. Johnston S, Martin M, O’Shaughnessy J, et al. Overall survival with abemaciclib in early breast cancer. Ann Oncol. Published online October 17, 2025. doi:10.1016/j.annonc.2025.10.005

    2. Eli Lilly Inc.: Lilly’s Verzenio (abemaciclib) prolonged survival in HR+, HER2-, high-risk early breast cancer with two years of treatment. Published October 17, 2025. Accessed October 17, 2025. https://investor.lilly.com/news-releases/news-release-details/lillys-verzenior-abemaciclib-prolonged-survival-hr-her2-high

    3. Johnston SRD, Harbeck N, Hegg R, et al. Abemaciclib combined with endocrine therapy for the adjuvant treatment of HR+, HER2-, node-positive, high-risk, early breast cancer (monarchE). J Clin Oncol. 2020;38(34):3987-3998. doi:10.1200/JCO.20.02514

    4. Rastogi P, O’Shaughnessy J, Martin M, et al. Adjuvant abemaciclib plus endocrine therapy for hormone receptor-positive, human epidermal growth factor receptor 2-negative, high-risk early breast cancer: results from a preplanned monarchE overall survival interim analysis, including 5-year efficacy outcomes. J Clin Oncol. 2024;42(9):987-993. doi:10.1200/JCO.23.01994

    Continue Reading