Taiho Oncology and Cullinan Therapeutics Present Data on Zipalertinib in Patients with NSCLC with EGFR mutations and Active Brain Metastases at the ESMO Congress 2025

Core Insights - Taiho Oncology, Inc. and Cullinan Therapeutics, Inc. announced new data from the REZILIENT2 study of zipalertinib, targeting advanced or metastatic non-small cell lung cancer (NSCLC) with specific EGFR mutations and CNS involvement [1][2] Group 1: Study Overview - The REZILIENT2 study is a Phase 2b clinical trial evaluating zipalertinib's safety and efficacy in patients with locally advanced or metastatic NSCLC harboring EGFR exon 20 insertion mutations or other uncommon mutations [6][9] - The study includes four cohorts, with one specifically focusing on patients with active brain metastases [6][8] Group 2: Patient Demographics and Treatment - As of February 2025, 32 patients were enrolled in the CNS involvement cohort, with a median of 2 prior lines of therapy [4][5] - Patients received zipalertinib at a dosage of 100 mg orally twice daily, with 21 patients having ex20ins mutations and 13 having other uncommon mutations [4][5] Group 3: Efficacy and Safety Data - Preliminary results indicated a 31.3% intracranial objective response rate and a 68.8% intracranial disease control rate among evaluable patients [7] - The median duration of response for intracranial activity was 8.1 months, while the systemic objective response rate was 27.6% with a median duration of 7.6 months [7] - Zipalertinib was well tolerated, with treatment-related adverse events of grade 3 or higher occurring in 25% of patients, including anemia and interstitial lung disease [5]