Black Diamond reports 60% ORR for silevertinib in 1L NSCLC; plans Phase 2 GBM trial; cash into 2H 2028

Black Diamond Therapeutics, Inc.

60% ORR (26/43) in 1L NSCLC with 35 distinct non-classical EGFR mutations; 86% CNS ORR in patients with brain metastases.
No new safety signals; AEs managed with supportive care; 29/43 patients remain on therapy, longest >19 months.
Plans randomized Phase 2 trial of silevertinib+TMZ in ~150 ND GBM patients, initiated 1H 2026, preliminary data expected 2028.
Cash $135.5M as of Sep 30, 2025, now expected to fund operations into 2H 2028; partner assumed for NSCLC pivotal.
PFS and DOR data for NSCLC (recurrent and frontline) expected at medical meeting in Q2 2026.

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