Black Diamond Therapeutics disclosed that its Phase 2 study of silevertinib in first‑line non‑small cell lung cancer (NSCLC) achieved a 60% objective response rate (ORR) across 43 patients, including a 86% CNS ORR among the 16 patients with brain metastases. The trial also reported a 91% disease‑control rate (DCR) and 25 partial responses plus one complete response, covering 35 distinct non‑classical EGFR mutations at a 200 mg daily dose.
The high ORR and CNS activity are significant because non‑classical EGFR mutations represent a subset of NSCLC that is often refractory to existing EGFR‑targeted therapies. Silevertinib’s ability to penetrate the blood‑brain barrier and achieve robust CNS responses addresses a critical unmet need for patients with brain metastases, a common driver of early disease progression in this population.
Black Diamond’s Q3 2025 financials show a net loss of $8.5 million, a marked improvement from the $15.6 million loss in Q3 2024, driven by disciplined R&D and G&A spending. The company’s cash position of $135.5 million, as of September 30 2025, is projected to fund operations through the second half of 2028, providing a comfortable runway for the upcoming GBM trial and potential regulatory milestones.
Management highlighted the GBM study, noting that roughly 50% of glioblastoma patients harbor EGFR alterations that could be targeted by silevertinib. The company plans to launch a randomized Phase 2 trial in newly diagnosed GBM patients in the first half of 2026, leveraging the drug’s brain‑penetrant properties to address a high‑need indication with limited effective options.
Analysts have responded positively to the data, citing the strong efficacy signals and the company’s robust cash position as key drivers of optimism. The announcement reinforces Black Diamond’s focus on a single, brain‑penetrant EGFR inhibitor and positions the company for potential partnership or licensing opportunities as it advances toward pivotal studies.
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