Roche-MediLink’s B7-H3 ADC meets primary endpoint in phase 3 SCLC trial, median survival 13.3 months

Roche and its partner MediLink reported phase 3 results for the B7-H3-directed antibody-drug conjugate (ADC) in small-cell lung cancer. The trial met its primary endpoint, with a median overall survival of 13.3 months.

The survival figure falls short of the 18.5 months reported by GSK's rival B7-H3 ADC in a separate phase 3 study of Chinese patients, and is only modestly above the 12-month median seen in a global phase 2 trial of other B7-H3 ADCs.

In the Roche study, the control arm received standard topotecan chemotherapy, which achieved a median overall survival of 9.4 months, indicating the new ADC improves on existing chemotherapy.

Cross-trial comparisons are limited, but the data place Roche's ADC, known as tam-peli or YL201, in the middle of the current B7-H3 ADC landscape, alongside other emerging therapies such as Amgen's DLL3xCD3 T-cell engager.