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  • Toripalimab Plus Chemo Maintains Survival Benefit After 6 Years in Recurrent/Metastatic NPC

    Toripalimab Plus Chemo Maintains Survival Benefit After 6 Years in Recurrent/Metastatic NPC

    After 6 years of follow-up, toripalimab-tpzi (Loqtorzi) plus chemotherapy maintained its survival advantage over chemotherapy alone in patients with recurrent or metastatic nasopharyngeal carcinoma (NPC), according to long-term overall survival (OS) findings from the phase 3 JUPITER-02 study (NCT03581786).1

    In this exploratory post-hoc analysis, findings from which were presented at the 2025 ESMO Asia Congress, patients treated with toripalimab plus gemcitabine and cisplatin achieved a median OS of 64.8 months vs 33.7 months with chemotherapy alone. This translated to a 31-month improvement and a 38% reduction in the risk of death (HR 0.62; 95% CI, 0.45-0.85). Coherus Oncology, the drug’s developer, stated that these results reinforce the regimen’s role in the recurrent/metastatic setting.

    “The new 6-year overall survival follow-up data give us even greater confidence to use toripalimab in patients with NPC that is recurrent or metastatic,” Victoria Villaflor, MD, professor and director of the Head and Neck Oncology Program in the Division of Hematology-Oncology, Department of Medicine, at the University of California Irvine School of Medicine, stated in a news release.

    “These data suggest a significant long-term OS benefit for patients living with [recurrent/metastatic] NPC,” Rosh Dias, MD, chief medical officer of Coherus Oncology, added in the news release. “With these long-term data, [toripalimab] in combination with chemotherapy, reinforces the data supporting this regimen as the standard of care for patients living with [recurrent/metastatic] NPC.”

    Long-Term OS Updates From JUPITER-02: Topline Takeaways

    1. Findings from an exploratory post-hoc analysis showed that toripalimab plus gemcitabine and cisplatin produced a median OS of 64.8 months vs 33.7 months with chemotherapy alone after 6 years of follow-up.
    1. This translated to a 31-month OS improvement and a 38% reduction in risk of death (HR 0.62; 95% CI, 0.45-0.85).
    1. Taken together with the efficacy and safety findings from JUPITER-02 to date, these updated data reinforce the regimen’s role as a standard of care in the recurrent/metastatic setting.

    What was the design of JUPITER-02?

    The JUPITER-02 was a randomized, double blind, placebo-controlled study that evaluated the addition of PD-1 blockade to standard chemotherapy in patients with recurrent or metastatic nasopharyngeal carcinoma.

    The trial enrolled 289 patients with metastatic or recurrent, locally advanced NPC who had not received previous systemic chemotherapy for recurrent or metastatic disease.2 Patients were randomly assigned 1:1 to receive toripalimab at 240 mg every 3 weeks or the corresponding dose of placebo before receiving chemotherapy every 3 weeks for up to 6 cycles, followed by either toripalimab or placebo maintenance for up to 2 years.2,3 The chemotherapy regimen included 1,000 mg/m2 of administered intravenous (IV) gemcitabine administered on days 1 and 8 and 80 mg/m² of IV cisplatin on day 1 of each cycle.

    The primary end point was progression-free survival (PFS) according to RECIST 1.1 criteria.2 Key secondary end points included OS, overall response rate, disease control rate, duration of response, and safety.

    What prior data have been reported from this trial?

    In JUPITER-02, the combination reduced the risk of disease progression or death by 48% vs chemotherapy alone (HR, 0.52; 95% CI, 0.36-0.74; P < .0003).4 The median PFS was 11.7 months (95% CI, 11.0–not evaluable [NE]) in the combination arm (n = 146) vs 8.0 months (95% CI, 7.0-9.5) in the control arm (n = 143).2 The median OS was not reached (95% CI, 38.7 months, not estimable) with the toripalimab combination vs 33.7 months (95% CI, 27.0, 44.2) with chemotherapy alone (95% CI, 27.0-44.2).4 This translated to a 37% reduction in the risk of death vs chemotherapy alone (HR, 0.63; 95% CI, 0.45-0.89; P = .0083).

    These results supported the 2023 FDA approval of toripalimab in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with metastatic or recurrent locally advanced nasopharyngeal carcinoma.2 The FDA also approved toripalimab as monotherapy for patients with recurrent unresectable or metastatic NPC who progressed on or after platinum- containing chemotherapy based on findings from the phase 2 POLARIS-02 trial (NCT02915432).

    What are the key safety considerations for toripalimab plus chemotherapy?

    Toripalimab is often associated with immune-mediated adverse effects (AEs) such as pneumonitis, colitis, hepatitis, endocrinopathies, nephritis with renal dysfunction, and skin adverse reactions.1

    The most frequently observed (≥ 20%) AEs with toripalimab plus chemotherapy included nausea, vomiting, decreased appetite, constipation, hypothyroidism, rash, pyrexia, diarrhea, peripheral neuropathy, cough, musculoskeletal pain, upper respiratory infection, insomnia, dizziness, and malaise.

    References

    1. Coherus announces six-year JUPITER-02 follow-up results showing LOQTORZI plus chemotherapy nearly doubles median overall survival in nasopharyngeal carcinoma. News release. Coherus. December 8, 2025. Accessed December 8, 2025. https://investors.coherus.com/news-releases/news-release-details/coherus-announces-six-year-jupiter-02-follow-results-showing
    2. The efficacy and safety study of toripalimab injection combined with chemotherapy for nasophapyngeal cancer. ClinicalTrials.gov. Updated September 2, 2025. Accessed December 8, 2025. https://www.clinicaltrials.gov/ct2/show/NCT03581786
    3. FDA approves toripalimab-tpzi for nasopharyngeal carcinoma. FDA. October 27, 2023. Accessed December 8, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-toripalimab-tpzi-nasopharyngeal-carcinoma
    4. Coherus and Junshi Biosciences announce FDA approval of Loqtorzi (toripalimab-tpzi) in all lines of treatment for recurrent or metastatic nasopharyngeal carcinoma (NPC). News release. Coherus BioSciences and Shanghai Junshi Biosciences. October 27, 2023. Accessed December 8, 2025. https://investors.coherus.com/news-releases/news-release-details/coherus-and-junshi-biosciences-announce-fda-approval-loqtorzitm

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  • GLPG5101 Yields Rapid Time to Infusion, Durable Responses in R/R NHL, MCL | Targeted Oncology

    GLPG5101 Yields Rapid Time to Infusion, Durable Responses in R/R NHL, MCL | Targeted Oncology

    Results from the ongoing phase 1/2 ATALANTA-1 trial (CTIS: 2022-502661-23-00; NCT06561425) indicate that GLPG5101, a novel CD19-targeted chimeric antigen receptor (CAR) T-cell therapy, demonstrated a manageable safety profile and notable efficacy results in patients with relapsed/refractory (R/R) non-Hodgkin lymphoma (NHL) including mantle cell lymphoma (MCL).1,2

    Results from the MCL cohort were announced at the 2025 ASH Annual Meeting by Marie Jose Kersten, MD, PhD, professor of hematology at Amsterdam UMC, on December 7, 2025.1 Previous results were published in Blood on November 5, 2024.2

    The therapy showed high and durable antitumor activity across the studied NHL subtypes. In the R/R MCL patient cohort (n = 24), at 9.1 months’ median follow-up, all the patients achieved an overall response, and the complete response (CR) rate was 95.8%.1

    The therapy is distinguished by its use of a fresh, stem-like, early memory T-cell phenotype and a rapid, decentralized manufacturing platform that enables a 7-day vein-to-vein time.

    Efficacy was evaluated in 42 patients who had reached the first response assessment. The objective response rate (ORR) was 88% (n = 37/42).2 The CR rate was 83% (n = 35/42). Of 11 responding patients in phase 1 of the study, 10 had an ongoing response at the data cutoff and 1 patient completed the study while in CR. In phase 2 of the study, all 21 patients had an ongoing response at the data cut off. Of the total patients, 4 (3 with diffuse large B-cell lymphoma [DLBCL] and 1 with MCL) experienced progression after achieving an initial response.

    GLPG5101 demonstrated robust expansion in the body across all tested dose levels and disease indications. Persistent CAR T-cells were detected in peripheral blood for up to 21 months post-infusion, indicating long-term durability.

    Minimal residual disease (MRD) negativity in plasma was achieved in 12 of 15 (80%) evaluable patients who had achieved a CR. Crucially, all 11 MRD-negative patients with a minimum of 6 months follow-up remained in ongoing CR at the time of data cut off, linking deep molecular remission to durable clinical benefit.

    In the R/R MCL cohort, 90% (n = 9/10) of MRD-evaluable patients were MRD-negative at CR. Additionally, 7 of the 9 MRD-negative patients remained in CR at the time of the data cut off.1

    Safety Profile of GLPG5101

    GLPG5101 demonstrated a manageable safety profile with low incidence of high-grade toxicities in the MCL cohort. The reported data reflects treatment-emergent adverse events (TEAEs) reported up to 14 weeks post-infusion.

    In phases 1 and 2, any grade cytokine release syndrome (CRS) occurred in 9 vs 10 patients. Grade 3 or higher CRS occurred in 1 vs 0 patients. Any grade immune effector cell–associated neurotoxicity syndrome (ICANS) occurred in 6 vs 4 patients, and grade 3 or higher ICANS occurred in 0 vs 1 patients.

    The most frequently reported TEAEs of grade 3 or higher were hematologic. Out of 49 infused patients, 2 died during the treatment period and 1 died during follow-up.

    Study Design and Patient Characteristics

    This is an ongoing phase 1/2 study designed to evaluate the safety and efficacy of GLPG5101.

    The primary objectives of phases 1 and 2 are to establish the safety, determine the recommended phase 2 dose, and to evaluate the efficacy of GLPG5101. The secondary objectives are to assess manufacturing feasibility, further safety parameters, and additional efficacy metrics such as duration of response and MRD.

    The ATALANTA-1 trial enrolled heavily pretreated adult patients with various subtypes of R/R NHL. Patients had a median of 2 prior systemic therapies. Eligible indications included DLBCL, MCL, follicular lymphoma, marginal zone lymphoma, Burkitt lymphoma, and primary central nervous system lymphoma.

    In the MCL cohort, the median age of patients in phase 1 was 66.5 years (range, 25–78), and 67 years (range, 40–81) in phase 2. The median range of prior therapies between both phases was 2.5 (range, 1–7) vs 3 (range, 2–11). The majority of patients had received prior Bruton tyrosine kinase inhibitor.1

    As of the data cutoff, 53 patients had undergone leukapheresis, 49 received an infusion, and 47 of the 49 patients received fresh product. In the R/R MCL cohort, 25 patients received CAR T-cell infusion, with 24 patients receiving fresh product.

    A 7-day vein-to-vein time was successfully achieved in 43 of the 47 patients (91%) who received the fresh product. In the R/R MCL cohort specifically, 23 of 24 patients achieved a 7-day vein-to-vein time. Short vein-to-vein time eliminated the need for cytotoxic bridging therapy for all patients who received a fresh product.

    The final product demonstrated significant enrichment of desired T-cell phenotypes compared to the starting material. The proportion of early T-cell phenotypes (naive/stem cell memory and central memory) was significantly increased in both CD4+ and CD8+ CAR T cells. A median increase in the CD4:CD8 ratio of CAR+ T cells was observed in the final product.

    In August 2025, GLPG5101 received a regenerative medicine advanced therapy designation in MCL from the FDA based on preliminary clinical data.3

    The interim results from the ATALANTA-1 study provide strong evidence for the potential of GLPG5101 as a novel CAR T-cell therapy for R/R NHL. The rapid, 7-day vein-to-vein manufacturing time is a significant logistical advantage that can accelerate access to treatment for patients with urgent clinical needs..

    “In conclusion, in the ATALANTA-1 study, we saw deep and durable responses in patients with MCL, including patients with high-risk features, of course with relatively short follow-up,” concluded Kersten during the presentation.1 “And we saw…a 96% CR in patients with high-risk disease and a duration of response at 9 months of 83%. We have a very favorable safety profile, no grade 3 or higher CRS and only 1 patient with grade 3 ICANS. We would feel very comfortable even in [patients with MCL] to deliver this therapy on an outpatient basis…All in all, we think this product should be further developed.”

    REFERENCES
    1. Kersten M, Vermaat J, Mutsaers P, et al. High complete response rates and minimal residual disease (MRD) negativity, with durable responses, in high-risk mantle cell lymphoma (MCL) with GLPG5101, a fresh, early memory-enriched CAR T-cell therapy with a 7-day vein-to-vein time: Results from the ATALANTA-1 MCL cohort. Presented at: 2025 ASH Annual Meeting; December 7, 2025; Orlando, Florida. Abstract 662.
    2. Kersten M, Saevels K, Willems E, et al. ATALANTA-1: A phase 1/2 trial of GLPG5101, a fresh, stem-like, early memory CD19 CAR T-cell therapy with a 7-day vein-to-vein time, for the treatment of relapsed/refractory non-Hodgkin lymphoma. Blood. 2024;144(suppl 1):93. doi:10.1182/blood-2024-205360.
    3. Galapagos NV announces U.S. FDA Regenerative Medicine Advanced Therapy (RMAT) designation granted to GLPG5101 for the treatment of relapsed/refractory mantle cell lymphoma. News release. Galapagos NV. Published February 10, 2025. Accessed August 12, 2025. https://tinyurl.com/vkvnfvps

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  • Banning stablecoin remuneration will not protect banks’ deposits

    Banning stablecoin remuneration will not protect banks’ deposits

    Stablecoins are here to stay and regulators, far from burying their heads in the sand, are taking on the new challenge they present. Rules on how stablecoin issuers conduct their business are a necessary component of a stable financial ecosystem in which these instruments play a role. But what is driving the formation of these rules?

    When seeking to protect financial stability from the new threats stablecoins present, there are two scenarios that concern central banks. First, rapid redemptions of stablecoins would require the issuer to quickly dispose of reserve assets, causing a slump in the price of these assets (or the funding liquidity of deposit takers) and risking contagion. The second scenario is the possibility that the increasing popularity of stablecoins will cause banks to lose deposits.

    Protecting banks from rapid runs is part of regulators’ responsibilities. Runs on solvent and viable banks are a market failure and, as such, financial stability policy should be calibrated to reduce their likelihood.

    But does a structural migration of deposits away from banks into a new product – for example, stablecoins – necessarily represent a risk to financial stability? It should not present per se a crisis for bank funding.

    Banks have a variety of sources of financing and can lean on capital markets to ensure that they have the requisite capital to create credit and keep the economy running. Even if funding costs of banks increased, a necessary condition for regulatory intervention is a market failure. It would need to be associated with some positive externalities of banking, which would be lost if deposits migrate to narrow balance-sheet issuers of money, such as Tether or USDC.

    Making stablecoins less attractive won’t solve the issue

    Most regulators seem to see it as their obligation to ensure that stablecoins are structured to be less attractive than bank deposits. The evidence for this is clear: major stablecoin regimes from many jurisdictions prohibit the paying of interest. Since stablecoins are not remunerated, this prevents them from competing with bank deposits.

    Moreover, regulatory measures to protect bank deposits should not be based on the attempt to prevent stablecoins from being safe and trustworthy. Neither should they create new cyclicality and unintended instability of funding liquidity.

    Banning remuneration for stablecoin holders leads to the attractiveness of stablecoins versus bank deposits fluctuating with the interest rate. This means that both stablecoins and banks face fluctuating demand, rather than stability. News on the interest rate path becomes big news on the competitiveness and business models of stablecoins – relative to banking. And as the history of liquidity crises tells us, even small news can trigger big, self-fulfilling flows of funds.

    There is another explanation for the prevalence of the ban on remunerated stablecoins. In the same way as they did for central bank digital currencies, banks effectively lobbied regulators that remuneration of a new monetary instrument would compromise their business models.

    It may be the case that the link between deposits and banking is uniquely valuable. If it is, then central banks should say so and provide evidence, because insisting that stablecoin holders do not receive interest on their holdings does not make stablecoins safer or less likely to be the destination of acute deposit flight in the event of bank distress.

    An alternative approach

    Contrast this with an approach where stablecoin issuers are able to earn interest on reserves held at the central bank. First, this would mean that stablecoins were backed by the safest possible asset. Second, it would give the central bank a means of controlling the relative attractiveness of stablecoins versus bank deposits and limiting the likelihood of runs. Rapid inflows above a certain size could be negatively remunerated, limiting the amount of value stablecoin issuers are able to pass on to holders and thereby rendering them less attractive.

    Remuneration of stablecoins’ deposits with the central bank should however be lower than the one obtained by banks for four reasons. The first is the need for general initial prudence towards this new form of settlement asset. Second is the negative externalities from the use of stablecoins for illicit payments (applying only to stablecoins circulating on pseudonymous public blockchain networks and awaiting the achievement of a regulatory level-playing field with the banking system).

    The third reason is to protect the positive externalities of banking for society (which eventually require further proof). And fourth is because a part of the seignorage income generated by stablecoins would come from their safety, resulting from their full backing in central bank money, i.e. the possible perception that they are substitutes for central bank money. A part of the seignorage income that stablecoins generate should thus be owned by central banks.

    The spread between the remuneration of banks´ deposits with the central bank and those of stablecoins would summarise the views on these four points. This kind of framework both ensures the maximum safety of stablecoins and gives regulators a tool to address market failures.

    The alternative to this would be a laissez-faire approach that only imposes strict capital and liquidity requirements on stablecoin issuers (which should be done in any case). Imposing zero remuneration is counterintuitive and destabilising because of the unintended dependence of its effects on the level of interest rates.

    Ulrich Bindseil was Director General, Market Infrastructure and Payment Systems at the European Central Bank. Lewis McLellan is Head of Content, Digital Monetary Institute, OMFIF.

    This commentary expands on ideas discussed in a recent paper published by Ulrich Bindseil available here.

    Interested in this topic? Subscribe to OMFIF’s newsletter for more.

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  • INCA033989 Nets FDA Breakthrough Therapy Designation in CALR-Mutated R/R Essential Thrombocythemia

    INCA033989 Nets FDA Breakthrough Therapy Designation in CALR-Mutated R/R Essential Thrombocythemia

    The first-in-class mutant calreticulin (CALR)–targeted monoclonal antibody INCA033989 has been granted breakthrough therapy designation by the FDA for the treatment of patients with essential thrombocythemia harboring a type 1 CALR mutation who are resistant or intolerant to at least 1 cytoreductive therapy.1

    Data from the phase 1 INCA033989-101 (NCT05936359) and INCA033989-102 (NCT06034002) trials supported the designation. Findings from the trials presented during the 2025 European Hematology Association Congress demonstrated that no dose-limiting toxicities (DLTs) were reported in patients treated across dose levels (n = 49) and the maximum tolerated dose was not reached.2 At the data cutoff, most patients remained on treatment (98%) and the median duration of treatment exposure was 22.6 weeks (range, 0.6-69.2%). Updated results from the studies are planned to be presented during the 2025 ASH Annual Meeting.1

    “Incyte has long been committed to improving outcomes for patients with MPNs, and this Breakthrough Therapy designation underscores the potential of INCA033989 to be a novel therapy that could significantly transform the treatment of patients [with] essential thrombocythemia, who today have limited treatment options,” Pablo J. Cagnoni, MD, president and head of research and development at Incyte, stated in a news release. “The designation allows us to expedite the development pathway for INCA033989 in patients with type 1 mutations.”

    How were these phase 1 studies designed?

    The essential thrombocytopenia cohort of INCA033989-101 and INCA033989-102 trials enrolled patients with a diagnosis of essential thrombocytopenia per 2022 World Health Organization criteria.2 Patients also needed to have disease harboring a CALR exon 9 mutation, documented resistance or intolerance to at least 1 previous line of cytoreductive therapy, a platelet count of more than 450 × 109/L, and high-risk disease. High-risk disease was defined as being at least 60 years old, having a history of thrombosis, history of major bleeding without any clearly documented alternative explanation, or extreme thrombosis.

    INCA033989-101 enrolled patients outside the US and INCA033989-102 was a US-only study. Patients received intravenous INCA033989 every 2 weeks at doses ranging from 24 mg to 2500 mg.

    The primary end points were the incidences of DLTs and treatment-emergent adverse effects (TEAEs). Secondary end points included response rate per European LeukemiaNet criteria, symptom improvement per the Myeloproliferative Neoplasm Symptom Assessment Form total symptom score, changes in allele burden of mutant CALR, and pharmacokinetic measures.

    What additional safety and efficacy data have been reported with INCA033989?

    Additional findings from these studies showed that the best overall response rates among patients treated at the 24-mg to 250-mg dose levels were 80% and 86%, respectively. Respective complete response (CR) rates were 68% and 82% in patients who were treated in the 400-mg to 2500-mg dose range.

    Most evaluable patients (89%; n = 34/38) achieved a reduction in the variant allele frequency (VAF) of mutant CALR. Forty-seven percent of these patients experienced a reduction of more than 20% of mutant CALR VAF, and 21% achieved a greater than 50% reduction. A reduction of at least 20% of mutant CALR VAF occurred within 6 cycles for all 18 responders, and all molecular responders achieved a hematological response of either a CR or a partial response.

    Further safety data revealed that any-grade TEAEs occurred at a rate of 85.7%, including treatment-related (61.2%), grade 3 or higher (26.5%), and serious (6.1%) TEAEs. Treatment discontinuation (2.0%) and dose reduction (2.0%) due to TEAEs also occurred. Most TEAEs were grade 1 to 2 in severity and the most frequent grade 3 or higher TEAE was a transient increase in asymptomatic lipase levels (6.1%).

    “Looking ahead, we plan to initiate a phase 3 program evaluating INCA033989 in patients [with] essential thrombocythemia with all types of CALR mutations in mid-2026, following alignment with regulators in the first half of next year,” Cagnoni noted in the news release.1

    References

    1. Incyte’s first-in-class mutCALR-targeted monoclonal antibody, INCA033989, granted breakthrough therapy designation by U.S. FDA. News release. Incyte. December 7, 2025. Accessed December 8, 2025. https://incytecorp.gcs-web.com/news-releases/news-release-details/incytes-first-class-mutcalr-targeted-monoclonal-antibody
    2. Mascarenhas J, Ali H, Yacoub A, et al. INCA33989 is a novel, first-in-class, mutant calreticulin-specific monoclonal antibody that demonstrates safety and efficacy in patients with essential thrombocythemia (ET). Presented at: 2025 European Hematology Association Congress; June 12-15, 2025; Milan, Italy. Abstract LB4002

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  • Tiger Global launches new fund as it takes more disciplined approach

    Tiger Global launches new fund as it takes more disciplined approach

    Tiger Global Management announced Monday the launch of its latest venture capital fund, Private Investment Partners 17, targeting a raise between about $2 billion and $3 billion, according to a letter to investors viewed by CNBC.

    The hedge fund wrote that it’s expecting PIP 17 to be similar in “strategy, size and construction” to its earliest vintages and its most recent, PIP 16, which targeted $6 billion but ultimately closed at $2.2 billion.

    The largest positions in PIP 16 are OpenAI and Waymo.

    Compared to the megafunds of the early 2020s, the latest target signals a pivot to a more disciplined strategy for Tiger Global.

    The firm was one of the biggest forces in the startup ecosystem over the last half-decade, but has seen heavy markdowns and slower deployment in the last few years.

    In 2021, the heyday of its “spray and pray” approach, it led 212 rounds, according to Crunchbase data. This year, it made just nine new private investments.

    Tiger first invested in OpenAI in 2021 at a valuation of less than $16 billion and in Waymo that same year at $39 billion. Those stakes today are at massive gains.

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  • Inflation Expectations Steady; Consumers Expect Worsening Financial Situations and Rising Medical Costs

    NEW YORK—The Federal Reserve Bank of New York’s Center for Microeconomic Data today released the November 2025 Survey of Consumer Expectations, which shows that households’ inflation expectations remained unchanged at the short-, medium-, and longer-term horizons.  Expectations about the growth in medical care costs increased to its highest level since January 2014. Labor market expectations improved slightly, but respondents’ perceptions and expectations about their current and future financial situation became more negative. The survey was fielded from November 1 through November 30, 2025.

    The main findings from the November 2025 Survey are:

    Inflation

    • Median inflation expectations in November remained unchanged at the one-year-ahead horizon (3.2%) and remained steady at the three-year and five-year-ahead horizons (3.0%). The survey’s measure of disagreement across respondents (the difference between the 75th and 25th percentile of inflation expectations) decreased at all horizons
    • Median inflation uncertainty—or the uncertainty expressed regarding future inflation outcomes—remained unchanged at the one-year and three-year horizons and decreased at the five-year horizon.
    • Median home price growth expectations remained unchanged at 3.0% for the sixth consecutive month.
    • Median year-ahead commodity price change expectations increased by 0.2 percentage point for food (to 5.9%), 0.6 percentage point for gas (to 4.1%), 0.7 percentage point for the cost of medical care (to 10.1%), 0.2 percentage point for the cost of a college education (to 8.4%) and by 1.1 percentage points for rent (to 8.3%). The reading for the expected change in the cost of medical care is the highest since January 2014, shortly after the series began.

    Labor Market

    • Median one-year-ahead earnings growth expectations remained unchanged at 2.6% in November.
    • Mean unemployment expectations—or the mean probability that the U.S. unemployment rate will be higher one year from now—decreased by 0.4 percentage point to 42.1%.
    • The mean perceived probability of losing one’s job in the next 12 months decreased by 0.2 percentage point to 13.8%, the lowest reading since December 2024. The mean probability of leaving one’s job voluntarily, or the expected quit rate, in the next 12 months decreased by 1.1 percentage points to 17.7%, the lowest reading since February 2025.
    • The mean perceived probability of finding a job in the next three months if one’s current job was lost increased by 0.5 percentage point to 47.3%, while remaining below the trailing 12-month average of 49.8%.

    Household Finance

    • The median expected growth in household income increased to 2.9% in November from 2.8% in October, equaling its trailing 12-month average.
    • Median nominal household spending growth expectations increased by 0.2 percentage point to 5.0%.
    • Perceptions of credit access compared to a year ago deteriorated, with the net share of respondents expecting it will be easier versus harder to obtain credit a year from now decreasing, while expectations for future credit availability were largely unchanged.
    • The average perceived probability of missing a minimum debt payment over the next three months increased by 0.6 percentage point to 13.7%, modestly above the trailing 12-month average of 13.3%.
    • The median expectation regarding a year-ahead change in taxes at current income level increased by 0.9 percentage point to 4.1%, the highest reading since June 2024. The increase was broad-based across age, education, and income groups.
    • Median year-ahead expected growth in government debt increased by 2.0 percentage points to 9.2%, the highest reading since July 2024.
    • The mean perceived probability that the average interest rate on saving accounts will be higher in 12 months decreased by 0.8 percentage point to 24.1%.
    • Perceptionsabout households’ current financial situations compared to a year ago deteriorated notably with a larger share of respondents reporting that their households were worse off compared to a year ago, and a smaller share reporting they were better off. Expectations about year-ahead financial situations also deteriorated slightly with a smaller share of respondents reporting that their households are expecting to be better off a year from now.
    • The mean perceived probability that U.S. stock prices will be higher 12 months from now decreased by 1.0 percentage point to 37.9%.

     
    About the Survey of Consumer Expectations (SCE)

    The SCE contains information about how consumers expect overall inflation and prices for food, gas, housing, and education to behave. It also provides insight into Americans’ views about job prospects and earnings growth and their expectations about future spending and access to credit. The SCE also provides measures of uncertainty regarding consumers’ outlooks. Expectations are also available by age, geography, income, education, and numeracy. 

    The SCE is a nationally representative, internet-based survey of a rotating panel of approximately 1,200 household heads. Respondents participate in the panel for up to 12 months, with a roughly equal number rotating in and out of the panel each month. Unlike comparable surveys based on repeated cross-sections with a different set of respondents in each wave, this panel allows us to observe the changes in expectations and behavior of the same individuals over time. For further information on the SCE, please refer to an overview of the survey methodology here, the FAQs, the interactive chart guide, and the survey questionnaire.

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  • Dual BCMA/CD19 CAR T-cell Therapy AZD0120 Shows Promise for Multiple Myeloma

    Dual BCMA/CD19 CAR T-cell Therapy AZD0120 Shows Promise for Multiple Myeloma

    Treatment with the dual BCMA and CD19-targeted CAR T-cell therapy AZD0120 showed early responses and a tolerable safety profile with a quick manufacturing turnaround time for patients with relapsed/refractory multiple myeloma, according to preliminary findings from the phase 1b/2 DURGA-1 study (NCT05850234) presented at the 2025 ASH Annual Meeting.1,2

    At the time of the data cutoff date for the presentation, which was October 1, 2025, the median follow-up was 3.9 months.1 The overall response rate with AZD0120 across 2 dose levels (n = 23) was 96%, with a median time to response of 28 days. The complete response (CR) and stringent CR (sCR) rate with AZD0120 was 78.3% and the partial response (PR) rate was 17.4%. In patients with previous exposure to a BCMA-targeted CAR T cell (n = 5), the ORR was 100% with AZD0120, with a CR/sCR rate of 80%. The MRD negativity rate (<10-5) was 94% for those evaluable for minimal residual disease (MRD) assessment at 1 month (n = 17).

    “A single infusion of AZD0120 resulted in early and deep responses. Response deepens over time and was seen in BCMA-naive and -exposed patients,” lead investigator Shambavi Richard, MD, from the Icahn School of Medicine at Mount Sinai, in New York, New York, said during a presentation of the results. “The safety profile is well-suited for outpatient administration, with 35% of patients receiving infusion outpatient.” Richard is an associate professor of medicine (Hematology and Medical Oncology) with the Center of Excellence for Multiple Myeloma, and director of CAR T-cell Research and Stem Cell Transplant for Multiple Myeloma.

    Delving Into DURGA-1: AZD0120 in Multiple Myeloma

    • AZD0120 elicited rapid, deep responses in relapsed/refractory multiple myeloma, achieving an ORR of 96% and a CR/sCR rate of 78%, with strong activity even in BCMA-exposed patients.
    • The toxicity profile supported outpatient use, with mostly low-grade CRS, minimal neurotoxicity, and no dose-limiting toxicities or treatment-related deaths.
    • Ultra-fast manufacturing via the FasTCAR platform enabled vein-to-release in a median of 14 days and consistent in vivo expansion, supporting reliable and scalable clinical deployment.

    AZD0120 Manufacturing Process

    AZD0120 is a next-generation CAR T cell created using the FasTCAR rapid manufacturing platform. In this process, the cells are manufactured in less than 3 days, Richard noted. “This rapid manufacturing is facilitated by the elimination of ex vivo expansion,” she said. “The cells go through activation and transduction, and all expansion occurs in vivo, resulting in younger and fitter T cells.”

    The median time for manufacturing was 14 days from apheresis to release (range, 10-30) and 28 days from apheresis to infusion (range, 19-44). After infusion, the median time to peak cell expansion was 13 days. CAR T persistence was seen at day 56 for 100% of patients.

    At the beginning of the study, the manufacturing was completed externally but transitioned to an in-house approach in March 2025, with a 100% manufacturing success rate following the shift. “The next-generation platform is established for AZD0120, with a reliable turnaround time,” said Richard.

    Patient Characteristics and DURGA-1 Study Design

    In the study, after enrollment, patients underwent apheresis followed by lymphodepletion with fludarabine and cyclophosphamide at 5, 4, and 3 days prior to infusion of the CAR T-cell product. Bridging or debulking therapy were permitted as needed. AZD0120 was infused at 2 dose levels for 26 patients. Dose-level 1 (DL1) was 1 x 105 cells/kg and was received by 12 patients and DL2 was 3 x 105 cells/kg and was received by 14 patients.

    The median age of patients was 63 years (range, 44-78), and the median time from diagnosis was 6.7 years (range, 1.8-13.8). Extramedullary plasmacytomas were present in 1 patient (4%). The most common International Staging System disease stage was III (62%), and 35% of patients had 1 or more high-risk cytogenetic abnormalities. The most common high-risk feature was amp1q21 (23%), followed by t4;14 (8%), t14:16 (8%), and del17p (4%).

    The median prior lines of therapy were 4 (range, 3-7), and 85% of patients had received a prior autologous stem cell transplant. Seven patients (27%) received bridging therapy. Prior BCMA therapy was permitted in the study, with 5 patients having received a prior BCMA-targeted CAR T-cell therapy and 1 patient having received a BCMA T-cell engager. For those receiving a prior CAR T-cell therapy, the median time since treatment was 2.6 years (range, 1.9-4.8), and for the T-cell engager, it was 0.6 years. Eighty-eight percent of patients were refractory to their last treatment, and 69% were triple-class refractory.

    AZD0120 Safety Profile in DURGA-1

    There were no deaths, grade 4 or higher infections, or dose-limiting toxicities observed with AZD0120. Across both dose levels, the most observed grade 3/4 adverse effects (AEs) were neutrophil count decrease (81%), lymphocyte count decrease (50%), white blood cell count decrease (42%), anemia (23%), platelet count decrease (19%), infection (8%), febrile neutropenia (8%), and hypotension (8%).

    Across both doses, 62% of patients experienced cytokine release syndrome (CRS). At DL1, CRS occurred in 75% (n = 9) of patients compared with 50% for DL2 (n = 7). For DL1, all events were grade 1 in severity. For DL2, CRS was grade 1 for 6 of the patients and grade 2 for 1. The median onset to CRS was 9 days, and the median duration was 1.5 days. Tocilizumab (Actemra) was administered to 46% of patients, and dexamethasone was administered to 12%. One patient received anakinra.

    There were no cases of immune effector cell–associated neurotoxicity syndrome (ICANS) in the DL1 group compared with 1 case of grade 1 ICANS in the DL2 cohort. Richard added that there were no delayed neurotoxicities, Parkinsonism, cranial nerve palsies, or Guillain-Barré syndrome.

    “CRS onset was predictable at a median of 9 days, consistent with peak in vivo expansion at 13 days,” Richard said.

    Next Steps for AZD0120

    AZD0120 is being explored in multiple clinical trials, including a phase 1b/2 study for amyloid light chain amyloidosis (NCT07081646)3 and another phase 1 open-label study for multiple myeloma (NCT07073547).4 The CAR T-cell therapy is also the subject of studies for multiple sclerosis (NCT07224373) and lupus (NCT06897930).

    References

    1. Richard S, Gaballa M, Gregory T, et al. Safety and efficacy of AZD0120, a BCMA/CD19 dual-targeting CAR T-cell therapy, in relapsed/refractory multiple myeloma: Preliminary results from the DURGA-1 phase 1b/2 study. Blood. 2025;146(suppl 1):269. doi:10.1182/blood-2025-269
    2. A study of GC012F (AZD0120), a CAR T therapy targeting CD19 and BCMA in subjects with relapsed/refractory multiple myeloma. ClinicalTrials.gov. Updated August 6, 2025. Accessed December 8, 2025. https://www.clinicaltrials.gov/study/NCT05850234
    3. A phase 1b/2 study of CAR T cell therapy targeting CD19 and BCMA in participants with relapsed or refractory AL amyloidosis. (ALACRITY). ClinicalTrials.gov. Updated September 19, 2025. Accessed December 8, 2025. https://www.clinicaltrials.gov/study/NCT07081646
    4. A phase I, open-label, multicenter study to evaluate the safety, tolerability, cellular kinetics, immunogenicity, pharmacodynamics, and preliminary efficacy of AZD0120 in participants with multiple myeloma. ClinicalTrials.gov. Updated December 3, 2025. Accessed December 8, 2025. https://www.clinicaltrials.gov/study/NCT07073547

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  • Taiho Oncology Presents Data on All-Oral Regimens Azacitidine and Cedazuridine, and Decitabine and Cedazuridine at the 2025 American Society of Hematology Annual Meeting and Exposition

    Taiho Oncology Presents Data on All-Oral Regimens Azacitidine and Cedazuridine, and Decitabine and Cedazuridine at the 2025 American Society of Hematology Annual Meeting and Exposition

    • Two oral presentations will highlight Phase 2 results from the ASTX030-01 trial of oral azacitidine and cedazuridine in patients with myelodysplastic syndromes, chronic myelomonocytic leukemia or acute myeloid leukemia and Phase 2 results from ASTX727-03 trial of low-dose oral decitabine and cedazuridine in patients with lower-risk myelodysplastic syndromes
    • New data from 15 company-sponsored and company-funded externally led studies demonstrate increasing understanding of novel oral regimens in hematology

    PRINCETON, N.J., Dec. 8, 2025 /PRNewswire/ — Taiho Oncology, Inc., a company developing and commercializing novel treatments for hematologic malignancies and solid tumors, today announced new data from the company-sponsored ASTX030-01 and ASTX727-03 studies evaluating all-oral regimens of azacitidine and cedazuridine or decitabine and cedazuridine in patients with myelodysplastic syndromes (MDS), chronic myelomonocytic leukemia (CMML) or acute myeloid leukemia (AML). Data from the studies will be shared in two oral presentations at the 67th American Society of Hematology (ASH) Annual Meeting and Exposition, to be held on December 6-9, 2025, in Orlando, Florida. Collectively, new data from 15 company-sponsored and company-funded externally led studies will be presented, demonstrating an increasing commitment to understanding novel oral regimens in hematology.

    An oral presentation will highlight results from the Phase 2 ASTX030-01 trial, a multicenter, randomized, open-label, crossover trial comparing the all-oral combination of azacitidine and cedazuridine to subcutaneous azacitidine among patients with MDS, CMML or AML.

    A second oral presentation will share findings from the Phase 2 ASTX727-03 trial of low-dose oral decitabine and cedazuridine versus an attenuated course of standard-dose decitabine in patients with lower-risk MDS.

    Azacitidine and decitabine belong to a class of antineoplastic agents known as DNA methyltransferase inhibitors (DMTIs). Each is paired with cedazuridine, a cytidine deaminase inhibitor, to help the agent stay active in the body without degrading.

    “We are pleased to present positive data suggesting that oral azacitidine and cedazuridine in patients with MDS, CMML and AML, and decitabine and cedazuridine in patients with lower-risk MDS may be comparable in safety and effectiveness to frequently used parenteral therapies for those populations,” said Harold Keer, MD, PhD, Chief Medical Officer of Taiho Oncology. “While standard hypomethylating agents are administered via infusion in the clinic, these novel treatments are designed to be taken orally at home, potentially improving flexibility and lowering the treatment burden for patients.”

    Authors will report results from the ASTX030-01 study of oral azacitidine and cedazuridine versus subcutaneous azacitidine in patients with MDS, CMML or AML: 1

    Investigator Summary of Results

    As of the May 2025 data cutoff, 30 patients received treatment, including 22 individuals with MDS, five with CMML, two with AML and one with MDS/myeloproliferative neoplasms (MPN); all were eligible for single-agent azacitidine. The patients were randomly assigned in a 1:1 ratio to receive ongoing cycles of therapy. One group received ASTX030 except during cycle 2, when subcutaneous azacitidine was administered, while the other group received subcutaneous azacitidine in cycle 1 followed by ASTX030 in all subsequent cycles.

    As of the data cutoff, ASTX030 Phase 2 results demonstrated the following:

    • The primary endpoint was the geometric mean ratio (GMR) of azacitidine total cycle AUC 0–24 exposures after oral ASTX030 over subcutaneous azacitidine, and the result for that endpoint was 0.913 (90% confidence interval [CI]: 0.78, 1.07).
    • In patients with MDS (n=22), the complete response (CR) rate was 22.7% and overall response rate was 50%.
    • Among patients who were dependent on red blood cell (RBC) transfusions at baseline (n=13), 30.8% achieved independence from RBC transfusions for 56 days or more.

    When stratifying by body surface area (BSA), patients with intermediate BSA had a GMR of 0.980 (90% CI: 0.85, 1.13), whereas the subset of patients with a high BSA had a GMR of 0.700 (90% CI: 0.55, 0.89) and further simulations suggested that BSA-adjusted dosing will help ensure the PK exposure of the oral combination approximates that of subcutaneous azacitidine.

    Summary of Preliminary Safety and Tolerability

    • Adverse events (AEs) were reported in 100% of trial participants, with 83.3% of those AEs classified as grade 3 or higher.
    • The most common treatment-emergent adverse events (TEAEs), the majority of which were grade 1 or 2, were nausea (70%), constipation (66.7%) and fatigue (60%).
    • The most common TEAEs of grade 3 or higher were thrombocytopenia (43.3%), neutropenia (33.3%) and anemia (30%).
    • AEs leading to treatment withdrawal or dose reduction occurred in two (6.7%) and four (13.3%) patients, respectively, and there were 12 (40%) AEs that led to treatment interruption or delay.

    Authors will report results from the ASTX727-03 study of low-dose oral decitabine and cedazuridine versus standard-dose decitabine and cedazuridine in patients with lower-risk MDS2

    Investigator Summary of Results

    As of the October 2024 data cutoff, 81 patients with low-risk or intermediate-1 MDS and either one or more cytopenias or dependence on red blood cell transfusions were treated in the Phase 2 ASTX727-03 study, comparing a low-dose (LD), all-oral regimen of decitabine and cedazuridine with an attenuated course of standard dose (SD) decitabine and cedazuridine (DEC-C). Patients received 10 mg of oral decitabine and 100 mg cedazuridine for five days or 35 mg decitabine and 100 mg cedazuridine for three days. Patients were treated a median of 8.8 months, with patients in the LD arm receiving a median of 10 cycles and those in the SD arm receiving a median of 9 cycles.

    As of the data cutoff, ASTX727-03 Phase 2 results demonstrated the following:

    • Median overall survival (OS) was 23.9 months in the LD arm versus 26.0 months in the SD arm.
    • Median leukemia-free survival (LFS) was 23.8 months in the LD arm versus 25.7 months in the SD arm.
    • Hematologic improvement per International Working Group 2006 criteria was achieved in 27.5% LD patients and 26.8% SD patients.
    • Among patients dependent on RBC transfusions, 52.4% of LD patients and 37.5% SD patients achieved RBC transfusion independence.
    • Pharmacokinetic exposure AUC in the LD arm was approximately half that in the SD arm.

    Summary of Preliminary Safety and Tolerability

    • Delayed cycles occurred in 72.5% of patients in the LD arm versus 82.9% of those in the SD arm. Dose reductions occurred in 40% of patients in the LD cohort versus 46.3% of patients in the SD group.
    • Both treatment regimens caused a decrease in blood counts. Neutropenia was more pronounced in early cycles and was more severe in the SD arm. Blood counts across all lineages remained stable or improved through 12 or more cycles with the LD arm, suggesting a more favorable safety and tolerability profile.
    • AEs of grade 3 or higher occurred in 85% of patients in the LD arm and 90.2% of patients in the SD arm. Treatment discontinuation due to AEs occurred in 2.5% of patients in the LD arm versus 17.1% of patients in the SD arm.
    • The most commonly reported treatment-emergent AEs were anemia (42.5% LD versus 39% SD), fatigue (32.5% LD versus 43.9% SD) and thrombocytopenia (37.5% LD versus 39% SD).
    • 3 deaths occurred in the trial: 2 in the LD arm, both unrelated to study treatment, and 1 in the SD arm due to pseudomonal bacteremia in cycle 1, which was treatment-related.

    About Taiho Oncology, Inc.

    The mission of Taiho Oncology, Inc. is to improve the lives of patients with cancer, their families and their caregivers. The company specializes in the development and commercialization of orally administered anti-cancer agents for various tumor types. Taiho Oncology has a robust pipeline of small-molecule clinical candidates targeting solid-tumor and hematological malignancies, with additional candidates in pre-clinical development. Taiho Oncology is a subsidiary of Taiho Pharmaceutical Co., Ltd. which is part of Otsuka Holdings Co., Ltd. Taiho Oncology is headquartered in Princeton, New Jersey and oversees its parent company’s European and Canadian operations, which are located in Baar, Switzerland and Oakville, Ontario, Canada.

    For more information, visit https://www.taihooncology.com/, and follow us on LinkedIn and X.

    Taiho Oncology and the Taiho Oncology logo are registered trademarks of Taiho Pharmaceutical Co., Ltd.

    Taiho Oncology Contact:

    Leigh Labrie

    (609) 664-9878

    [email protected]

    References

    1. Guillermo Garcia-Manero et al. A phase 2 dose confirmation trial of oral ASTX030, a combination of oral azacitidine with cedazuridine among patients with myelodysplastic syndromes, chronic myelomonocytic leukemia, and acute myeloid leukemia
    2. Guillermo Garcia-Manero et al. Low-dose oral decitabine and cedazuridine among patients with low-risk myelodysplastic syndromes

    SOURCE Taiho Oncology


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  • Bank of England cutting jobs as part of overhaul after critical Bernanke review | Bank of England

    Bank of England cutting jobs as part of overhaul after critical Bernanke review | Bank of England

    The Bank of England has said it is cutting jobs amid sweeping changes at Threadneedle Street after a highly critical review into its failure to forecast surging inflation.

    Under budget pressures as it responded to the report from the former US Federal Reserve chair Ben Bernanke, the Bank has opened a voluntary scheme last week as part of an efficiency drive to find savings.

    The process, which will run until mid-January, with staff expected to leave in March, was first reported by Bloomberg. The Bank said it was “a mutually agreed, time-limited scheme for staff to choose to apply to leave.

    “We are now implementing a significant, multiyear transformation of our operations and this will condition our decisions. We are committed to ensuring the Bank is efficient, resilient and fit for the future.”

    Threadneedle Street is undergoing an overhaul after Bernanke’s investigation called for the Bank to revamp its forecasting process to avoid a repeat of its flat-footed response to Britain’s deepest inflation shock in four decades.

    The Bank, which is led by the governor, Andrew Bailey, said this year it was facing “difficult trade-offs” to meet its efficiency targets at the same time as pursuing its transformation programme, which includes updating its forecasting models and the communication of its interest rate decisions.

    It is understood no target has been set for the number of staff who are expected to leave the Bank. The scheme will offer the same terms as current redundancy payouts – which is 10% of salary multiplied by years of service, capped at £150,000 or two years’ service, whichever is the lower amount.

    The Bank’s most recent annual report showed headcount rose by more than 300 to 5,731 in the year to the end of February 2025. While most staff are based in London, it is in the process of increasing staff numbers in Leeds to 500 by 2027 as part of an expansion programme announced last year.

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    The Bank is widely expected to cut interest rates at its forthcoming monetary policy meeting on Thursday next week. Financial markets are anticipating a sixth reduction in borrowing costs to 3.75%, down from 4% and a recent peak of 5.25% in the middle of last year.

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