Black Diamond to Present NSCLC PFS Data After 60% ORR, 93% DCR
Black Diamond expects to present progression-free survival data for frontline NSCLC candidate silevertinib next quarter after reporting 60% ORR, 93% disease control rate and 86% CNS response in 43-patient cohort. The company’s lean operating model provides more than two years of runway to fund its planned phase 2 glioblastoma trial.
1. Next-Quarter NSCLC PFS Data Catalyst
Chief executive Mark Velleca said the company plans to present progression-free survival data for frontline NSCLC patients treated with silevertinib next quarter, marking a key catalyst that could validate its efficacy against non-classical EGFR mutations.
2. Frontline Phase 2 Efficacy Results
In a 43-patient frontline cohort, silevertinib achieved a 60% confirmed objective response rate, 93% disease control rate and 86% CNS response, with 29 patients remaining on therapy and the longest treatment duration exceeding 19 months, indicating early durability.
3. GBM Program and Financial Runway
Black Diamond’s lean operating model provides over two years of cash runway to support its planned randomized phase 2 glioblastoma trial initiating next quarter, with preliminary PFS readouts expected in the first half of 2028 after enrolling newly diagnosed GBM patients.