Cullinan Therapeutics Cancer Drug Shows Efficacy In Brain Metastases Among Lung Cancer Patients With Certain Mutations

Core Insights - Taiho Oncology Inc. and Cullinan Therapeutics Inc. presented new data from the CNS involvement cohort of the REZILIENT2 study for zipalertinib in advanced or metastatic NSCLC with specific EGFR mutations, to be showcased at ESMO Congress 2025 [1] Summary of Preliminary Efficacy - The ongoing Phase 2b REZILIENT2 trial includes a CNS involvement cohort where 32 patients received zipalertinib 100 mg orally twice daily, with a median of 2 prior lines of therapy [3] - Among the enrolled patients, 21 had ex20ins mutations and 13 had other uncommon mutations [3] - In the evaluable population (n=16), the intracranial objective response rate was 31.3%, with one complete response, and the intracranial disease control rate was 68.8% [4] - The median intracranial duration of response was 8.1 months [4] - The preliminary systemic objective response rate was 27.6% with a median duration of response of 7.6 months [5] - Intracranial antitumor activity was comparable to overall systemic anticancer activity [5] Summary of Preliminary Safety and Tolerability - Zipalertinib was well tolerated at the administered dose, with no new safety signals reported [6] - Treatment-related adverse events of grade 3 or higher occurred in 25% of patients, including anemia and interstitial lung disease, with one death attributed to interstitial lung disease [6] - Following the data release, CGEM stock increased by 4.96% to $7.77 [6]