Weekly Digest - 03-09 Jun 2023
CAR-T Digest - August 2020
CAR-T Digest - August 2020
CAR-T Digest - August 2020
CAR-T Digest - August 2020
Weekly Digest - 03-09 Jun 2023
Jun 05, 2023: Erdafitinib (IV) / Urothelial Cancer / Janssen: Improved Overall Survival
- Phase 3 THOR study met its primary endpoint of OS for Cohort 1 evaluating Erdafitinib vs Chemo Urothelial cancer and selected FGFR gene alterations, prior treatment with an Anti-PD-L1
- Erdafitinib reduced the risk of death by 36%
- Confirmatory data presented at ASCO 2023 for Erdafitinib vs Chemo significantly improved OS, PFS, and ORR along with consistent safety profile
- mOS: 12.1 months vs 7.8 months
- mPFS: 5.6 months vs 2.7 months
- ORR: 46% vs 12%
- grade (Gr) 3/4 TRAEs were 45.9% vs 46.4%
- Results from the Phase 2 NORSE study evaluating Erdafitinib alone and in combination with Cetrelimab
- ORR (Combo): 44.2% (Combo); 54.5% (Mono)
- mPFS: 10.97 months (Combo); 5.62 months (Mono)
- Grade 3+ TRAES: 45.5% (Combo); 46.5% (Mono)
- Results from the Phase 2 RAGNAR study evaluating Erdafitinib as a monotherapy
- ORR: 30%
- PR: 27%
- TRAEs: 8.3%
- Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials
