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
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Black Diamond's Lung Cancer Treatment Demonstrates 60% Response Rate in Phase 2 Results
Phase 2 Trial Results: Black Diamond Therapeutics reported topline data from its Phase 2 trial of silevertinib in non-small cell lung cancer patients, showing a 60% objective response rate and 86% CNS response rate, with no new safety signals observed.
Stock Performance: Following the trial results, BDTX stock experienced a significant decline of 23.77%, trading at $2.62.
Future Plans: The company plans to present updated trial results in 2026 and is also set to initiate a randomized Phase 2 trial for glioblastoma patients in the first half of 2026.
Financial Outlook: Black Diamond has approximately $135.5 million in cash and investments, which it believes will cover operating expenses into the second half of 2028.
