Black Diamond reports updated Phase 2 silevertinib data and FDA registration path
BDTX•Black Diamond Therapeutics reported updated Phase 2 results for silevertinib, with a 60% overall response rate, 93% disease control rate and 15.0-month median progression-free survival in the intent-to-treat population. It said FDA feedback supported a potential registration path and preliminary Phase 3 data are anticipated in 2028, assuming trial initiation in the second quarter of 2027.
1. Phase 2 results
Black Diamond Therapeutics reported a 60% overall response rate, 93% disease control rate and 15.0-month median progression-free survival in the intent-to-treat population. For patients with untreated brain metastases, the company reported an 86% central nervous system overall response rate and 12.2-month systemic median progression-free survival.
2. Potential registration path
The company said FDA feedback supported a clear path to potential registration in first-line EGFR-mutant non-small cell lung cancer. Assuming Phase 3 trial initiation in the second quarter of 2027, Black Diamond anticipates preliminary data in 2028.
