Zipalertinib Demonstrates Clinically Meaningful Intracranial Antitumor Activity in Patients with NSCLC with EGFR Exon 20 Insertion or Uncommon EGFR Mutations and Active CNS Metastases
Key Highlights
- ➤Zipalertinib achieved 30.2% intracranial response rate among 43 evaluable patients
- ➤Intracranial disease control reached 72.1%, with 9.7-month median response duration
- ➤59 patients enrolled in Phase 2 REZILIENT2 Cohort C; median follow-up 9.2 months
- ➤Grade ≥3 treatment-related adverse events affected 20.9% of patients
- ➤Cullinan Therapeutics (CGEM) and Taiho will present results at ESMO Congress 2026
Expert Statements
Helena A. Yu, MD, Thoracic Medical Oncologist at Memorial Sloan Kettering Cancer Center and study investigator
“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.”
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.”
Harold Keer, MD, PhD, Chief Medical Officer, Taiho Oncology
“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.”
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.”
Jeffrey Jones, MD, MBA, Chief Medical Officer, Cullinan Therapeutics
“The REZILIENT program was designed to explore zipalertinib's potential in clinically important settings where additional treatment options are needed.”
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.”
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
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