Black Diamond Therapeutics Announces Phase 2 Trial Data for Silevertinib in NSCLC
Black Diamond Therapeutics announced topline data from its Phase 2 trial of silevertinib in frontline non-small cell lung cancer, NSCLC, patients with non-classical epidermal growth factor receptor, EGFR, mutations, NCMs, and outlined plans for a randomized Phase 2 trial of silevertinib in patients with newly diagnosed glioblastoma. Silevertinib Phase 2 1L NSCLC Initial Clinical Results and Program Update: For the 43 patients enrolled, preliminary efficacy data is as follows: 25 confirmed partial responses, 1 confirmed complete response; 60% Objective Response Rate; 86% CNS ORR; 91% disease control rate. GBM Program Update and Phase 2 Plans: Key trial highlights include: Expected to enroll approximately 150 newly diagnosed patients, randomized to receive TMZ or silevertinib + TMZ; Initial focus will be on EGFRvIII-positive patients who are MGMT-negative; Randomization and treatment will begin after patients have had their surgical resection and radiation; Primary endpoint is PFS, with an interim analysis; secondary endpoint is overall survival; Trial will be governed by an Independent Data Monitoring Committee
