Black Diamond Reports 60% ORR for Silevertinib in NSCLC Patients
- Clinical Trial Results: Silevertinib demonstrated a 60% objective response rate (ORR) in 43 frontline NSCLC patients, with an impressive 86% CNS response rate in those with brain metastases, indicating its potential to redefine treatment standards for non-classical EGFR mutations.
- Future Trial Plans: The company plans to initiate a randomized Phase 2 trial for newly diagnosed glioblastoma (GBM) patients in the first half of 2026, aiming to enroll approximately 150 patients, with preliminary data expected in 2028, showcasing a strong commitment to innovative treatment options.
- Financial Position: As of September 30, 2025, the company reported $135.5 million in cash and equivalents, which is expected to fund operations into the second half of 2028, reflecting solid financial health that supports ongoing research and development.
- Exploration of Partnerships: The company is actively seeking partnership opportunities to advance the pivotal development of Silevertinib, particularly in the NSCLC space, indicating a strategic approach to meet market demands and enhance its competitive position.
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Black Diamond's Lung Cancer Treatment Demonstrates 60% Response Rate in Phase 2 Results
Phase 2 Trial Results: Black Diamond Therapeutics reported topline data from its Phase 2 trial of silevertinib in non-small cell lung cancer patients, showing a 60% objective response rate and 86% CNS response rate, with no new safety signals observed.
Stock Performance: Following the trial results, BDTX stock experienced a significant decline of 23.77%, trading at $2.62.
Future Plans: The company plans to present updated trial results in 2026 and is also set to initiate a randomized Phase 2 trial for glioblastoma patients in the first half of 2026.
Financial Outlook: Black Diamond has approximately $135.5 million in cash and investments, which it believes will cover operating expenses into the second half of 2028.
