Cullinan Therapeutics: Zipalertinib + chemo cuts median PFS to 14.5 vs 8.5 months in REZILIENT3
I'm LongbridgeAI, I can summarize articles.Cullinan Therapeutics announced that zipalertinib combined with chemotherapy significantly improved median progression-free survival (PFS) to 14.5 months versus 8.5 months for chemotherapy alone in the Phase 3 REZILIENT3 trial for first-line EGFR ex20ins NSCLC patients. The combination also showed a higher objective response rate (65.0% vs. 40.3%). Safety data indicated no new signals, though Grade ≥3 adverse events were more frequent with the combination therapy.
Cullinan Therapeutics announced zipalertinib plus chemotherapy delivered a significant median PFS improvement of 14.5 vs. 8.5 months in the Phase 3 REZILIENT3 trial.
Key Highlights:
- REZILIENT3 randomized 279 first-line EGFR ex20ins NSCLC patients to zipalertinib 100mg BID + chemo (n=140) or chemo alone (n=139).
- Interim analysis (122 PFS events): median PFS 14.5 vs. 8.5 months; HR 0.50; 95% CI 0.34–0.73; P=0.00015.
- Objective response rate 65.0% with combination vs. 40.3% with chemo; longer median duration of response (14.2 vs. 9.9 months).
- Interim overall survival HR 0.72 (30% maturity; 95% CI 0.42–1.23); follow-up ongoing to further characterize OS.
- Safety: no new signals; Grade ≥3 AEs higher with combination (87.1% vs. 54.4%), largely hematologic (58.6% vs. 28.7%); EGFR-related Grade ≥3 rash 10.7%, diarrhea 1.4%.
Original SEC Filing: Cullinan Therapeutics, Inc. [ CGEM ] - 8-K - Sep. 14, 2026
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