Cullinan reports 30.2% brain metastasis response with zipalertinib

Full story: https://grafa.com/en/news/united-states/cullinan-zipalertinib-rezilient2-brain-metastases-response-2026

• Cullinan Therapeutics and Taiho Oncology reported a 30.2% intracranial objective response rate among 43 evaluable patients in Cohort C of the Phase 2 REZILIENT2 trial.

• Zipalertinib achieved a 72.1% intracranial disease control rate and a median intracranial duration of response of 9.7 months in patients with EGFR-mutated lung cancer and active brain metastases.

• The companies plan to present the findings at the ESMO Congress 2026 in Madrid, October 23–27, while continuing zipalertinib's clinical and regulatory development.

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.

The Phase 2 REZILIENT2 findings also showed 72.1% intracranial disease control and a median intracranial response duration of 9.7 months.

“The intracranial responses observed with zipalertinib in REZILIENT2 are encouraging and support continued evaluation of zipalertinib in this difficult-to-treat patient population,” said study investigator Helena A. Yu, MD.

The study enrolled 59 patients, including individuals with leptomeningeal disease, while 20.9% of evaluable patients experienced Grade 3 or higher treatment-related adverse events.

Cullinan and Taiho plan to present the findings at ESMO Congress 2026, October 23–27, while continuing clinical development of the investigational treatment.

Among 24 patients without prior EGFR inhibitor exposure, the intracranial response rate reached 37.5%, although the subgroup's limited size restricts broader conclusions.

Zipalertinib is an oral EGFR inhibitor under development for certain genetically defined lung cancers, with a separate U.S. regulatory application already under FDA review.