Cullinan: Naabot ng Phase 3 REZILIENT3 trial ng zipalertinib + chemo ang PFS endpoint

Ang Phase 3 REZILIENT3 trial ay nakamit ang pangunahing endpoint nito sa nakaplanong interim analysis, na nagpapakita ng istatistikal na makabuluhang 6-buwan na median PFS benefit (14.5 vs 8.5 months, HR 0.50) para sa zipalertinib kasama ang chemotherapy kumpara sa chemotherapy lamang sa first-line EGFR ex20ins NSCLC. Ang objective response rate ay mas mataas din nang makabuluhan (65.0% vs 40.3%). Ang data ay ipinakita sa Presidential Symposium sa WCLC 2026.

Mahahalagang fact

Na-file: Set 14, 2026, 11:29 AM
Kaganapan: Topline na resulta
Direksyon: Positibo
Kumpanya: CGEMCullinan
Asset: zipalertinib
Pinagmulan: SEC 8-K
Kumpiyansa: May source
Kalendaryo: Desisyon ng FDA (PDUFA) · Peb 27, 2027 · Positibo
HR: 0.50
ORR: 65.0% kumpara sa 40.3%
P-value: 0.00015
Panggitnang PFS: 14.5 kumpara sa 8.5 buwan

Sipi mula sa source

EX-99.1 2 cgem-ex99_1.htm EX-99.1 EX-99.1 Exhibit 99.1 Zipalertinib Plus Chemotherapy Demonstrates 6-Month Median Progression-Free Survival Benefit in REZILIENT3 Phase 3 Trial in First-Line EGFR Exon 20 Insertion Mutation Non-Small Cell Lung Cancer Results from the Phase 3 REZILIENT3 trial were featured in a Presidential Symposium at WCLC 2026 and demonstrated a statistically significant improvement in progression-free survival in first-line EGFR exon 20 insertion mutation NSCLC at a planned interim analysis PRINCETON, N.J., TOKYO, Japan, CAMBRIDGE, Mass., September 13, 2026 — Taiho Oncology, Inc., Taiho Pharmaceutical Co., Ltd., and Cullinan Therapeutics, Inc. (Nasdaq: CGEM) today announced results from the Phase 3 REZILIENT3 trial evaluating zipalertinib plus chemotherapy versus chem

SEC 8-K