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#默沙东

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Oct 3Sat
  1. N Engl J Med73

    Phase 3 Trial of Weekly Oral Islatravir-Lenacapavir for HIV-1 Treatment.

    Once-weekly oral islatravir-lenacapavir maintained viral suppression as well as once-daily bictegravir-emtricitabine-tenofovir alafenamide in a phase 3 trial of 607 adults with virologically suppressed HIV-1. At week 48, HIV-1 RNA of 50 copies per milliliter or higher was reported in no ISL/LEN participants and 1 (0.3%) on B/F/TAF, meeting a 4-percentage-point noninferiority margin. The finding supports a long-acting weekly oral option for suppressed patients.

    Why it matters: Phase 3 data show a weekly oral HIV regimen can replace daily tablets without loss of suppression.

Aug 31Mon
  1. Lancet68

    Belzutifan plus lenvatinib versus cabozantinib in patients with previously treated advanced renal cell carcinoma (LITESPARK-011): an open-label, randomised, controlled, phase 3 trial.

    Belzutifan plus lenvatinib extended progression-free survival over cabozantinib in previously treated advanced clear-cell renal cell carcinoma. In the phase 3 LITESPARK-011 trial, 747 patients with disease progression after anti-PD-1 or anti-PD-L1 therapy were randomly assigned to belzutifan-lenvatinib or cabozantinib. Progression-free survival by masked independent central review was significantly longer with belzutifan-lenvatinib, while overall survival did not differ significantly, and the authors suggest belzutifan-lenvatinib may become a new standard of care in this setting.

    Why it matters: Phase 3 data on a potential new standard of care after checkpoint inhibitor therapy in advanced clear-cell renal cell carcinoma.

  2. Lancet73

    Switch to once-weekly, single-tablet islatravir-lenacapavir from daily standard of care for HIV-1 (ISLEND-2): a multicentre, randomised, open-label, active-controlled, phase 3 non-inferiority trial.

    Switching virologically suppressed adults with HIV-1 to a once-weekly, single-tablet regimen of islatravir (2 mg)-lenacapavir (300 mg) was non-inferior to continuing daily oral standard of care in the phase 3 ISLEND-2 trial. At week 48, HIV-1 RNA viral load of 50 copies per mL or higher occurred in 1 of 314 participants on islatravir-lenacapavir versus 4 of 312 on standard of care, meeting the non-inferiority margin of 4%. Treatment-related adverse events occurred in 18% of the islatravir-lenacapavir group versus fewer than 1% of the standard-of-care group, though discontinuations due to adverse events were rare in both groups.

    Why it matters: Phase 3 data support the first once-weekly complete oral single-tablet regimen for HIV-1 treatment.

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