Black Diamond Reports 15.2-Month mPFS, 86% CNS ORR in NSCLC Phase 2
Black Diamond Therapeutics’ Phase 2 trial of frontline silevertinib in 43 EGFR non-classical NSCLC patients delivered a median progression-free survival of 15.2 months and a 60% objective response rate. It showed an 86% CNS response with no brain metastases, manageable toxicity after dose reduction and median response duration not reached.
1. Efficacy Results in NSCLC Patients
In a Phase 2 trial of 43 treatment-naïve NSCLC patients with EGFR non-classical mutations, silevertinib dosed at 200 mg once daily achieved a median progression-free survival of 15.2 months (95% CI: 10.8; NE) and a 60% objective response rate by RECIST 1.1, with median duration of response not reached after 11.2 months’ follow-up.
2. CNS Response and Safety
The study demonstrated an 86% CNS objective response rate by RANO-BM and no de novo brain metastases in evaluable patients. Safety was manageable, with grade 3+ treatment-related adverse events reduced to 28% following dose reduction, supporting a 150 mg daily dose for pivotal development.
3. Upcoming Presentations and FDA Meeting
Data will be presented at the 2026 ASCO Annual Meeting on May 30, and Black Diamond plans to meet with the FDA later this year to discuss a pivotal development plan for silevertinib in EGFR non-classical NSCLC.