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#临床读出

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Oct 14Wed
  1. nature.com50

    Personalized neoantigen-targeting cancer vaccines in ovarian cancer: a phase 1 trial

    Personalized neoantigen vaccines combined with PD-1 blockade were feasible in patients with high-grade serous ovarian cancer in a phase 1 trial. Many patients mounted tumor-specific immune responses. Cell-free DNA analysis identified putative resistance mechanisms related to antigen presentation. The trial establishes feasibility of this approach in ovarian cancer and points to antigen presentation as a resistance pathway.

Oct 10Sat
  1. Nat Med62

    Extended follow-up of in vivo BCMA CAR-T therapy in relapsed/refractory multiple myeloma.

    Extended follow-up of in vivo BCMA CAR-T (ESO-T01), given without leukapheresis or lymphodepletion to four patients with relapsed/refractory multiple myeloma, shows no new important adverse events beyond the initial report at up to 15 months. One patient maintained stringent complete response for 15 months; median progression-free survival was 4.0 months (range 3.0-15.0). Three patients relapsed or progressed, all with extramedullary involvement, and died during follow-up, indicating limited CAR-T persistence requiring platform optimization.

Oct 8Thu
  1. JAMA59

    Advance Care Planning for Black and White Older Adults With Serious Illness: The EQUAL ACP Randomized Trial.

    Facilitated and self-guided advance care planning produced similar 1-year completion rates overall, but the facilitated approach worked relatively better for Black participants. Among Black participants, 71% completed ACP with facilitated versus 62% with self-guided care; among White participants, completion was 68% versus 78%. The race-by-intervention interaction was significant (adjusted RR, 1.32 [95% CI, 1.03-1.69]) among 789 participants, and facilitator racial concordance showed no association with completion.

Oct 7Wed
  1. JAMA61

    Smoking Cessation Among Underserved Patients Referred for Lung Cancer Screening: A Randomized Clinical Trial.

    Financial incentives of up to $600 roughly doubled sustained tobacco abstinence among medically underserved adults referred for lung cancer screening. In the trial of 3220 patients, biochemically confirmed abstinence through 6 months was 8.8% with incentives added to usual care and free pharmacotherapy, versus 4.3% with ask-advise-refer alone and 5.1% with pharmacotherapy added. Free pharmacotherapy alone did not improve abstinence over usual care.

Oct 1Thu
  1. Nat Med53

    Oral small-molecule GLP-1 receptor agonist safiglipron in early type 2 diabetes: a randomized, double-blind, placebo-controlled trial.

    Once-daily oral safiglipron reduced HbA1c by 1.20 to 1.45 percentage points versus placebo at 32 weeks in 284 adults with early type 2 diabetes managed with diet and exercise alone (OUTSTAND-1, phase 3). HbA1c below 7.0% was reached by 71.4-77.8% of safiglipron recipients versus 25.0% on placebo, with modest weight loss and mostly mild or moderate gastrointestinal adverse events. It offers an oral GLP-1 receptor agonist option taken without fasting or dietary restrictions.

    Why it matters: Phase 3 evidence that an oral small-molecule GLP-1 receptor agonist matches injectable-class glycemic efficacy.

Sep 10Thu
  1. nature.com51

    A bispecific CD3×CD19 antibody for systemic lupus erythematosus: a phase 1 trial

    A next-generation CD3×CD19 bispecific T cell engager given intravenously was well tolerated in patients with active systemic lupus erythematosus in a phase 1 trial, and most patients showed improvements in disease activity scores. The findings support further testing of B cell-directed T cell engagers in systemic lupus erythematosus.

    Why it matters: First-in-class tolerability and disease activity signal for a CD3×CD19 bispecific antibody in active SLE.

Sep 1Tue
  1. N Engl J Med78

    Eplontersen for Transthyretin Amyloid Cardiomyopathy.

    Eplontersen, an antisense oligonucleotide that reduces hepatic transthyretin production, did not reduce cardiovascular death or recurrent cardiovascular events in transthyretin amyloid cardiomyopathy. In the phase 3 CARDIO-TTRansform trial, 1432 patients received subcutaneous eplontersen 45 mg or placebo every 4 weeks for 140 weeks; the primary composite occurred at a rate ratio of 0.89 (95% CI, 0.73 to 1.09; P = 0.28). The finding leaves no demonstrated outcome benefit for eplontersen on top of standard treatment in ATTR-CM.

    Why it matters: Negative phase 3 result for eplontersen in 1432 patients with ATTR-CM at 140 weeks.

Aug 30Sun
  1. NEJM Evid63

    Durability of RSV Prefusion F Vaccine Protection across Two RSV Seasons.

    A single dose of the RSVpreF vaccine remained associated with fewer RSV-related RTD hospitalizations among adults 60 years or older in a second RSV season, with an incidence of 0.11 versus 0.25 events per 1000 person-years and vaccine effectiveness of 56.2% (95% CI, -12.4% to 84.8%), down from 83.3% in season one. Across both seasons of the 130,991-participant intention-to-treat analysis, vaccine effectiveness was 70.6% (95% CI, 39.1%-87.0%). The results extend RSVpreF protection beyond one season while indicating waning estimates.

    Why it matters: First randomized data on how well one RSVpreF dose protects older adults through a second RSV season.

Aug 28Fri
  1. NEJM Evid41

    Consolidation Therapy Based on Mutation Clearance in Acute Myeloid Leukemia.

    Intermediate-risk AML patients in CR1 who cleared all leukemia-associated mutations (variant allele frequency <2.5%) and received high-dose cytarabine consolidation had a median relapse-free survival of 33.1 months versus 11.7 months in a historical HiDAC-treated cohort of 239 patients (P=0.015, not meeting the prespecified 0.01 threshold after an unplanned interim assessment). The prospective phase II study of 100 patients, which assigned patients with persistent LAMs to allogeneic transplantation, supports mutation clearance as a guide to consolidation choices pending a randomized trial.

Aug 27Thu
  1. Lancet58

    Efficacy and safety of once-weekly subcutaneous zenagamtide, a novel unimolecular GLP-1 and amylin receptor agonist, in type 2 diabetes: a multicentre, randomised, parallel, double-blind, placebo-controlled, dose-finding, phase 2 trial.

    Once-weekly subcutaneous zenagamtide, a unimolecular GLP-1, amylin and calcitonin receptor agonist, lowered HbA1c in adults with type 2 diabetes on metformin with or without an SGLT2 inhibitor in a 36-week phase 2 dose-finding trial. Across doses of 0·4 to 40 mg, HbA1c fell from a baseline mean of 7·8% by up to -1·7%, with a treatment difference versus placebo of -1·56% at the highest dose (p<0·0001). Adverse events were mostly mild to moderate gastrointestinal effects; 21 of 261 exposed participants had serious adverse events and no deaths occurred.

    Why it matters: Phase 2 dose-response data on a single-molecule GLP-1 and amylin agonist for type 2 diabetes published in the Lancet.

Aug 21Fri
  1. Lancet69

    High-dose chemotherapy followed by autologous stem-cell transplantation versus non-myeloablative consolidation in primary CNS lymphoma (MATRix/IELSG43): a randomised phase 3 trial.

    Thiotepa-based HCT-ASCT consolidation after MATRix induction significantly improved 3-year progression-free survival in newly diagnosed primary CNS lymphoma compared with non-myeloablative R-DeVIC: 78% versus 51% in the 229 analysed patients. HCT-ASCT caused more adverse events per patient and five fatal consolidation-related events versus two with R-DeVIC. The findings establish HCT-ASCT as the preferred consolidation strategy in fit patients.

    Why it matters: First randomised phase 3 comparison showing HCT-ASCT superiority over non-myeloablative consolidation in primary CNS lymphoma.

CBACBA Frontier Insights (CFI)Chinese Biopharmaceutical Association (CBA)www.cba-usa.org