Black Diamond Therapeutics' Silevertinib Phase 2 Success
Analysis based on 6 articles · First reported May 21, 2026 · Last updated May 21, 2026
The positive Phase 2 results for Silevertinib are expected to significantly boost the stock price of Black Diamond Therapeutics, as the drug shows potential to address an unmet medical need in NSCLC. This development could also attract further investment into the biotechnology and pharmaceutical sectors, particularly for companies focused on oncology.
Black Diamond Therapeutics announced positive Phase 2 trial results for its investigational drug, Silevertinib, in frontline non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) non-classical mutations. The trial demonstrated a preliminary median Progression-free Survival (mPFS) of 15.2 months and robust CNS activity, with no patients developing de novo brain metastases. The Objective Response Rate (ORR) was 60% across a broad spectrum of EGFR-NCMs. Julia Rotow from the Dana–Farber Cancer Institute will present these data at the 2026 American Society of Clinical Oncology Annual Meeting. Black Diamond Therapeutics plans to meet with the United States — Food and Drug Administration to discuss the pivotal development plan for Silevertinib, which is also being investigated for glioblastoma multiforme (GBM).
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