NovaBridge announced a productive FDA Type B meeting confirming givastomig’s potential eligibility for an accelerated approval pathway in 1L Her2-, CLDN18.2+, PD-L1+ GEC, based on positive Phase 1b data. The company intends to initiate a registrational Phase 3 combination trial as early as Q4 2026 using ORR as the primary endpoint.
Key takeaways
FDA confirmed givastomig’s potential eligibility for accelerated approval in 1L Her2-, CLDN18.2+, PD-L1+ GEC
Registrational Phase 3 trial initiation planned as early as Q4 2026 with immunochemotherapy combination and ORR primary endpoint
Phase 1b ORR of 75% (77% at 8 mg/kg Q2W, 73% at 12 mg/kg Q2W, n=52 evaluable)
Phase 1b mPFS of 16.9 months and 82% 6-month PFS rate (n=53 evaluable)
Good overall tolerability without dose-dependent toxicity in Phase 1b combination
Detailed Phase 1b data to be presented at major medical conference in H2 2026