sacituzumab tirumotecan
Sacituzumab tirumotecan plus pembrolizumab improves PFS in PD-L1-negative NSCLC
In a 455-patient Phase III trial, median progression-free survival was 15.0 months versus 5.7 months with chemotherapy plus pembrolizumab.
Hana Sorensen
Biotech and trials correspondent.
Hana Sorensen covers drug developers, clinical trials and their results for Clinical Observer. Hana writes from trial registries, company filings, preprints and published reporting, and links every source.
Ebola vaccine trial
First Ebola vaccine trial in DR Congo begins in Bunia
Ervebo, approved for the Zaire strain, will be tested for cross-protection against the Bundibugyo virus causing the outbreak of more than 9,700 cases.
Merck-Moderna cancer vaccine
Merck and Moderna report phase 3 cancer vaccine data early after leak
INTerpath-001 showed 24-month recurrence-free survival of 82.2% with the vaccine plus Keytruda versus 70.0% for Keytruda alone, but distant metastasis-free survival was weaker than phase 2 and Moderna shares dropped.
Brepocitinib uveitis
Brepocitinib meets primary endpoint in two phase 3 uveitis trials
Median time to treatment failure was more than 48 weeks on the drug versus about 12 weeks on placebo, and 62% of patients achieved steroid-free quiescence compared with 20% on placebo.
PANKU-Breast01
Izalontamab brengitecan cuts progression risk by 59% in HR+/HER2- breast cancer
Phase 3 PANKU-Breast01 data presented at ESMO show median progression-free survival of 8.2 months versus 4.0 months with chemotherapy, though overall survival remains immature.
Off-label GLP-1s
Telehealth platforms prescribe GLP-1s off-label for addiction
Addiction-focused telehealth companies are marketing branded and compounded GLP-1 drugs for alcohol and other substance use disorders without FDA approval for those uses.
Vyglxia
FDA accepts Biohaven’s troriluzole resubmission
The agency will hold an advisory committee meeting and has set a review goal in the first quarter of 2027, Biohaven said.
Bictegravir/lenacapavir
Gilead posts phase 3 results for bictegravir/lenacapavir
At week 48, 0.8% of participants on the fixed-dose combination and 1.1% on a stable baseline regimen had HIV-1 RNA of at least 50 copies/mL, according to the registry posting.
Next-gen GLP-1s
Retatrutide and amylin combos move toward regulatory decisions
Lilly's triple-agonist retatrutide posted 20.8% weight loss in a phase 3 diabetes trial, while amylin-GLP-1 combinations CagriSema and EloraTZP await FDA steps and further testing.
