Black Diamond Therapeutics Announces Preliminary Phase 2 Data for Silevertinib in 1L NSCLC and Plans for a Phase 2 Trial of Silevertinib in GBM

Core Insights - 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 and plans for a randomized Phase 2 trial in newly diagnosed glioblastoma (GBM) patients [1][2] Group 1: Phase 2 Trial Results - The Phase 2 trial enrolled 43 frontline NSCLC patients with 35 distinct non-classical EGFR mutations, including 16 patients with brain metastases [3][4] - Silevertinib demonstrated an objective response rate (ORR) of 60% and a central nervous system (CNS) response rate of 86% among the enrolled patients [5][4] - 29 out of 43 patients remain on therapy, with the longest ongoing treatment exceeding 19 months [4][3] Group 2: Safety and Efficacy - No new safety signals were observed, with common adverse events including rash, stomatitis, diarrhea, and paronychia [6][7] - Adverse events were managed effectively without compromising the depth or durability of the response [7] Group 3: Future Plans and Financials - The company plans to initiate a randomized Phase 2 trial of silevertinib in newly diagnosed GBM patients in the first half of 2026, with initial data expected in 2028 [9][10] - As of September 30, 2025, the company reported cash, cash equivalents, and investments totaling $135.5 million, sufficient to fund operations into the second half of 2028 [4][13]