ArriVent's Firmonertinib Fails Phase 3 Primary Endpoint in Lung Cancer While Rival Readouts Deliver Wins

ArriVent BioPharma reported that its Phase 3 FURVENT trial of firmonertinib (240 mg) in first-line EGFR exon 20 insertion mutant non-small cell lung cancer did not meet its primary endpoint. Blinded independent central review evaluated progression-free survival came in at 11.0 months for firmonertinib versus 9.5 months for chemotherapy, a difference that did not reach statistical significance with a p-value of 0.0654. Management said secondary metrics showed clinical activity and that it is reviewing full results to determine next steps for the program.

On the same morning, Kairos Pharma reported positive, statistically significant interim efficacy data from its Phase 2 trial of ENV-105, also known as carotuximab, in metastatic prostate cancer, with median progression-free survival exceeding one year. ENV-105 is a first-in-class CD105-targeting monoclonal antibody designed as a resistance-modulating therapy in the castration-resistant setting.

Also drawing attention before the open, OS Therapies announced a statistically significant final three-year overall survival benefit for patients treated with its Herlystic therapy in its Phase 2b trial of pulmonary metastatic osteosarcoma, sending shares up approximately 19.4 percent in premarket trading.