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#强生

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Oct 15Thu
  1. N Engl J Med76

    Long-Acting HIV Therapy in African Adults with Adherence Challenges.

    Long-acting injectable cabotegravir plus rilpivirine every 8 weeks maintained viral suppression in African adults with HIV and adherence challenges, matching daily oral dolutegravir-based therapy. At week 48, 91.0% of the long-acting group (244 of 268) had a viral load below 50 copies per milliliter versus 89.2% of the oral group (240 of 269), meeting noninferiority. Confirmed virologic failure occurred in 5 participants (1.9%) on long-acting therapy and none on oral therapy.

    Why it matters: It tests long-acting injectable HIV therapy in the population most affected by adherence failure: African adults with suboptimal adherence.

  2. N Engl J Med77

    Phase 2 Trial of Icotrokinra for Patients with Ulcerative Colitis.

    Once-daily oral icotrokinra, a peptide that blocks the interleukin-23 receptor, beat placebo for clinical response at week 12 in adults with moderately to severely active ulcerative colitis: 63% at 400 mg, 58% at 200 mg and 55% at 100 mg versus 27% on placebo (P<0.001 for all). The 400-mg group also showed more clinical remission (30% vs. 11%), symptomatic remission (46% vs. 19%) and endoscopic improvement (37% vs. 14%). It offers an oral alternative to injected interleukin-23-targeted antibodies.

    Why it matters: An oral interleukin-23 receptor blocker matched injected antibodies' mechanism with positive phase 2 results.

Sep 11Fri
  1. nature.com51

    Teclistamab versus lenalidomide-dexamethasone in high-risk smoldering multiple myeloma: a randomized phase 2 trial

    Teclistamab produced higher rates of complete clinical responses than lenalidomide-dexamethasone in patients with high-risk smoldering multiple myeloma in the randomized phase 2 ImmunoPRISM trial. Longer follow-up is needed to determine whether it durably prevents progression to multiple myeloma.

    Why it matters: First randomized comparison of teclistamab against lenalidomide-dexamethasone in high-risk smoldering myeloma.

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 19Wed
  1. N Engl J Med88

    Talquetamab-Daratumumab in Relapsed or Refractory Myeloma.

    In a phase 3 trial of relapsed or refractory multiple myeloma after at least one prior line of therapy, talquetamab plus daratumumab (Tal-D) or with pomalidomide (Tal-DP) beat daratumumab-pomalidomide-dexamethasone (DPd) on progression-free survival: 24-month estimates of 81.3% and 77.6% versus 51.2%, with hazard ratios of 0.28 and 0.33. Complete response or better reached 71.1% and 69.0% versus 34.5%, and MRD-negative complete response 52.3% and 46.3% versus 15.9%. The results position GPRC5D-directed bispecific therapy earlier in the treatment sequence.

    Why it matters: Phase 3 data show talquetamab regimens outperforming standard daratumumab-based therapy in relapsed myeloma after just one prior line.

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