Black Diamond Therapeutics Shared Topline Data From Its Phase 2 Trial Of Silevertinib In Frontline Non-small Cell Lung Cancer, And Plans For Phase 2 Trial Of Silevertinib In Newly Diagnosed Glioblastoma

Benzinga·12/03/2025 12:09:24

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Silevertinib delivers robust anti-tumor activity as demonstrated by an ORR of 60% and a CNS response rate of 86% in 43 1L NSCLC patients presenting with 35 different non-classical EGFR mutations; no new safety signals observed to date
PFS data for 1L NSCLC patients expected in Q2 2026; Company continues to explore partnership opportunities for pivotal development of silevertinib
Based on encouraging CNS activity of silevertinib in multiple trials across NSCLC and GBM, Company plans to initiate a randomized Phase 2 trial of silevertinib in newly diagnosed GBM patients in 1H 2026; initial data anticipated in 2028
Cash, cash equivalents, and investments of $135.5 million as of September 30, 2025; expected to be sufficient to fund operations into 2H of 2028