Overview
- In the phase 2 BDTX-1535-101 first-line cohort (n=43), investigator-assessed ORR was 60% with 25 confirmed partial responses and 1 complete response, and CNS ORR reached 86% per RANO-BM.
- The disease control rate was 91%, 29 of 43 patients remained on treatment at data cutoff, and the longest ongoing response has exceeded 19 months.
- With a November 3, 2025 data cutoff and 7.2 months of median follow-up, all patients received 200 mg of oral silevertinib once daily.
- The cohort encompassed 35 distinct non-classical EGFR mutations, and no new safety signals were observed; common adverse events included rash, stomatitis, diarrhea, and paronychia.
- Black Diamond plans a randomized phase 2 trial in newly diagnosed EGFR-altered glioblastoma in the first half of 2026, expected to enroll about 150 patients comparing temozolomide alone versus silevertinib plus temozolomide, and it expects to present updated NSCLC durability data in the second quarter of 2026.