Clinical TrialMay 21, 2026, 05:16 PM
Black Diamond Silevertinib Phase 2 mPFS 15.2 months in NSCLC
AI Summary
Black Diamond Therapeutics announced positive Phase 2 trial results for silevertinib in frontline non-small cell lung cancer (NSCLC) patients with EGFR non-classical mutations. The trial showed a preliminary median Progression-free Survival (mPFS) of 15.2 months and an Objective Response Rate (ORR) of 60%. Silevertinib also demonstrated robust CNS activity with an 86% CNS ORR and prevented de novo brain metastases. These encouraging data will be presented at the 2026 ASCO Annual Meeting, and the company plans to discuss pivotal development with the FDA.
Key Highlights
- Preliminary median Progression-free Survival (mPFS) was 15.2 months (95% CI: 10.8; NE).
- Overall Objective Response Rate (ORR) was 60% in patients with EGFR-NCMs.
- Robust CNS activity observed with an 86% CNS ORR; no de novo brain metastases.
- 23 of 43 patients (53%) remain on therapy, with longest at 23.5 months.
- Rate of TRAEs > Grade 3 was reduced to 28% following dose reduction.
- Company plans to meet with the FDA later this year to discuss pivotal development.
- Data will be presented at the 2026 ASCO Annual Meeting on May 30, 2026.
- Randomized Phase 2 trial of silevertinib in GBM initiated in May 2026.
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