Business
Black Diamond Therapeutics Announces Positive Phase 2 Results for Silevertinib in Frontline NSCLC Patients with EGFR Non-Classical Mutations
Black Diamond Therapeutics Announces Positive Phase 2 Results for Silevertinib in Frontline NSCLC Patients with EGFR Non-Classical
About this update from Black Diamond Therapeutics, Inc.
[{"type":"text","content":"Preliminary mPFS of 15.2 months; mDOR not reachedRobust CNS activity, with 86% CNS ORR; no patients developed de novo brain metastasesORR 60% in patients with a broad spectrum of EGFR-NCMs, including PACCDose dependent and manageable AE profile, no new safety signals observedWebcast on Thursday, May 21, 2026 at 5:30 pm EDT CAMBRIDGE, Mass., May 21, 2026 (GLOBE NEWSWIRE) -- Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with cancer, today announced positive results from its Phase 2 trial of silevertinib in frontline (1L) non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) non-classical mutations (NCMs). These data will be presented by Julia Rotow, M.D., Clinical Director, Lowe Center for Thoracic Oncology at the Dana-Farber Cancer Institute, at the 2026 American Society of Clinical Oncology® (ASCO®) Annual Meeting on Saturday, May 30, 2026, 1:15 PM-2:45 PM CDT. “Silevertinib continues to demonstrate potential to become a practice changing frontline therapy for NSCLC patients with EGFR-NCMs, delivering robust preliminary mPFS that far exceeds historical data for currently available therapies” said Sergey Yurasov, M.D., Ph.D., Chief Medical Officer of Black Diamond Therapeutics. “Importantly, silevertinib prevented the development of de novo brain metastases in this patient population, where progression via CNS metastases frequently occurs. We look forward to meeting with the FDA later this year to discuss our pivotal development plan.” “Patients with EGFR non-classical mutations represent a meaningful and underserved subset of NSCLC, with historically poor progression-free survival on available frontline TKIs,” added Dr. Rotow. “The activity we are seeing with silevertinib across the full NCM spectrum, combined with its CNS activity, is highly encouraging, and I look forward to sharing these data with the oncology community at ASCO next week.”Silevertinib 1L NSCLC Phase 2 Results Summary Results as of an April 11, 2026 data cutoff date include:43 patients with 1L NSCLC were enrolled at a 200 mg once daily dose of silevertinib Patients presented with a broad spectrum of EGFR-NCMs, including compound and P-Loop and C-Helix Compressing (PACC) mutations19 patients with brain me...