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Sep 22Tue
  1. Nature Medicine52

    Trastuzumab plus nivolumab with gemcitabine and cisplatin as first-line therapy for HER2-positive unresectable biliary tract cancer: a phase 1b/2 trial

    A phase 1b/2 trial tested trastuzumab combined with nivolumab, gemcitabine and cisplatin as first-line therapy for HER2-positive unresectable biliary tract cancer. The regimen showed encouraging clinical response rates, and HER2 expression was associated with clinical benefit. The results support HER2 status as a marker guiding trastuzumab-based treatment in this population.

    Why it matters: First data on adding trastuzumab and nivolumab to standard gemcitabine-cisplatin in HER2-positive biliary tract cancer.

Aug 29Sat
  1. N Engl J Med55

    Milvexian with Antiplatelet Therapy after Acute Coronary Syndrome Event.

    Adding milvexian, an oral factor XIa inhibitor, to standard antiplatelet therapy within 7 days after an acute coronary syndrome did not reduce recurrent ischemic events. In 14,194 patients followed for a median of 12.2 months, the composite of cardiovascular death, myocardial infarction, or ischemic stroke occurred in 5.4% with milvexian versus 5.1% with placebo (hazard ratio, 1.05; 95% CI, 0.91 to 1.21). The trial was stopped for futility at a planned interim analysis; major bleeding rates were 0.3% in both groups.

    Why it matters: A large phase 3 trial shows factor XIa inhibition with milvexian failed to improve outcomes after acute coronary syndrome.

Aug 25Tue
  1. JAMA75

    Adjuvant Nivolumab vs Observation in Resected Non-Small Cell Lung Cancer: A Randomized Clinical Trial.

    Adjuvant nivolumab after upfront surgery did not improve disease-free survival in resected non-small cell lung cancer. Median disease-free survival was 71.3 months with nivolumab vs 68.8 months with observation (hazard ratio, 0.97; 1-sided P = .39), and the trial was stopped for futility. This contrasts with the established benefit of preoperative and perioperative nivolumab in this setting.

    Why it matters: A negative phase 3 trial clarifies that adjuvant nivolumab adds no benefit after upfront surgery in resected NSCLC.

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