other material
confidence high
sentiment positive
materiality 0.90
Cullinan's zipalertinib combo meets PFS endpoint in Phase 3 REZILIENT3 trial
Cullinan Therapeutics, Inc.
- REZILIENT3 Phase 3 trial (285 patients) met primary endpoint of PFS at planned interim analysis; statistically significant and clinically meaningful improvement.
- Zipalertinib plus platinum-based chemotherapy vs chemo alone in first-line EGFR exon 20 insertion NSCLC; safety manageable.
- Independent Data Monitoring Committee recommended unblinding; trial continues for efficacy/safety monitoring.
- Taiho and Cullinan plan to pursue U.S. FDA approval for the combination in first-line setting pending discussions.
- Full results to be submitted for presentation at an upcoming international medical conference.