Cullinan: REZILIENT3 Fase 3 zipalertinib + kemoterapi mencapai titik akhir PFS

Uji coba Fase 3 REZILIENT3 mencapai titik akhir utamanya pada analisis interim yang direncanakan, menunjukkan manfaat PFS median 6 bulan yang signifikan secara statistik (14,5 vs 8,5 bulan, HR 0,50) untuk zipalertinib ditambah kemoterapi dibandingkan kemoterapi saja pada NSCLC EGFR ex20ins lini pertama. Tingkat respons objektif juga secara signifikan lebih tinggi (65,0% vs 40,3%). Data tersebut dipresentasikan dalam Simposium Presiden di WCLC 2026.

Fakta utama

Diajukan: 14 Sep 2026, 11.29
Peristiwa: Hasil topline
Arah: Positif
Perusahaan: CGEMCullinan
Aset: zipalertinib
Sumber: SEC 8-K
Keyakinan: Bersumber
Kalender: Keputusan FDA (PDUFA) · 27 Feb 2027 · Positif
HR: 0.50
ORR: 65.0% berbanding 40.3%
nilai p: 0.00015
Median PFS: 14.5 berbanding 8.5 bulan

Kutipan sumber

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