Zipalertinib Demonstrates Clinically Meaningful Intracranial Antitumor Activity in Patients with NSCLC with EGFR Exon 20 Insertion or Uncommon EGFR Mutations and Active CNS Metastases
Intracranial Objective Response Rate of 30.2% was observed in 43 evaluable patients
Results to be shared in poster presentation at ESMO Congress 2026
PRINCETON, N.J. & CAMBRIDGE, Mass., October 19, 2026--Taiho Oncology, Inc. and Cullinan Therapeutics, Inc. (Nasdaq: CGEM) today announced results from Cohort C of the Phase 2 REZILIENT2 trial evaluating zipalertinib monotherapy in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion (ex20ins) mutations or other uncommon EGFR mutations and active central nervous system (CNS) metastases. The data will be presented at the European Society for Medical Oncology (ESMO) Congress 2026, October 23-27, in Madrid, Spain.
Mature results from the first prospective study evaluating intracranial activity of an EGFR tyrosine kinase inhibitor in this patient population demonstrated clinically meaningful intracranial antitumor activity. Among 43 evaluable patients, zipalertinib achieved an intracranial objective response rate of 30% and an intracranial disease control rate of 72%, with a median intracranial duration of response of 9.7 months. Zipalertinib was well tolerated.
"Patients with NSCLC harboring EGFR exon 20 insertion mutations or other uncommon EGFR mutations and active CNS metastases have a significant need for therapies that can effectively address disease in the brain," said Helena A. Yu, MD, Thoracic Medical Oncologist at Memorial Sloan Kettering Cancer Center and study investigator. "The intracranial responses observed with zipalertinib in REZILIENT2 are encouraging and support continued evaluation of zipalertinib in this difficult-to-treat patient population."
"The REZILIENT2 results reflect a rigorous examination of the CNS activity of zipalertinib as monotherapy in patients with EGFR ex20ins or uncommon EGFR-mutated NSCLC and active CNS metastases," said Harold Keer, MD, PhD, Chief Medical Officer, Taiho Oncology. "The findings add to the growing clinical evidence supporting the continued evaluation of zipalertinib in patients with EGFR-mutated NSCLC and brain involvement."
"The REZILIENT program was designed to explore zipalertinib's potential in clinically important settings where additional treatment options are needed," said Jeffrey Jones, MD, MBA, Chief Medical Officer, Cullinan Therapeutics. "Today's REZILIENT2 update extends that commitment by providing evidence of intracranial activity in patients with active CNS metastases."