
Cullinan reports 30.2% brain metastasis response with zipalertinib
Cullinan Therapeutics (NASDAQ:CGEM) and Taiho Oncology reported a 30.2% intracranial response rate for zipalertinib in 43 evaluable lung cancer patients with brain metastases.
Cullinan Therapeutics (NASDAQ:CGEM), Taiho Oncology, and Taiho Pharmaceutical announced that the global Phase 3 REZILIENT3 trial of zipalertinib plus platinum-based chemotherapy met its primary endpoint of progression-free survival in previously untreated patients with EGFR exon 20 insertion non-small cell lung cancer.
Cullinan Therapeutics (NASDAQ:CGEM) reported encouraging initial clinical data and outlined expanded development pathways for its portfolio of dual-targeting T-cell engagers, marking an expansion for the oncology-focused biotech into the autoimmune space.
Cullinan Therapeutics (NYSE:CGEM) received Orphan Drug Designation from the Food and Drug Administration (FDA) for its lead investigational oncology asset, CLN-049, accelerating the regulatory pathway for the treatment of high-risk acute myeloid leukemia (AML).
Cullinan Therapeutics (NASDAQ:CGEM), Taiho Oncology, and Taiho Pharmaceutical reported that zipalertinib plus chemotherapy improved median progression-free survival by six months versus chemotherapy alone in the Phase 3 REZILIENT3 trial.