Black Diamond reports Phase 2 silevertinib data, plans FDA meeting on pivotal path

Black Diamond Therapeutics reported second quarter 2026 financial results and a corporate update on August 5, 2026. At the ASCO Annual Meeting on May 30, 2026, the company presented Phase 2 data from 43 frontline NSCLC patients with non-classical EGFR mutations, including compound and PACC mutations, dosed with silevertinib at 200 mg once daily; as of an April 11, 2026 data cutoff, the objective response rate was 60%, CNS objective response rate was 86%, and disease control rate was 91%.¹ Median duration of response had not been reached, and preliminary median progression-free survival was 15.2 months. No patients developed de novo brain metastases, and 23 of 43 patients remained on therapy, with the longest at 23.5 months.¹

The rate of treatment-related adverse events of Grade 3 or higher fell to 28% after dose reduction, and patients maintained or deepened responses following the reduction.¹ The company said the safety, pharmacokinetic, pharmacodynamic and efficacy data support a 150 mg once-daily dose for pivotal development.¹

Black Diamond is seeking FDA feedback on a pivotal development path for silevertinib in frontline non-classical EGFRm NSCLC and expects to provide an update in the fourth quarter of 2026.¹ Separately, a Phase 2 trial combining silevertinib with temozolomide in newly diagnosed EGFRvIII-positive glioblastoma is enrolling patients in its safety lead-in portion, with the randomized portion expected to begin in the fourth quarter of 2026.¹

Black Diamond ended the second quarter with approximately $110.5 million in cash, cash equivalents and investments, down from $128.7 million at the end of 2025.¹ The company said this is expected to fund operations into the second half of 2028.¹