Black Diamond reports positive Phase 2 silevertinib results; mPFS 15.2 months in EGFR-NCM NSCLC

Black Diamond Therapeutics, Inc.

Preliminary mPFS 15.2 months (95% CI: 10.8, NE); median DOR not reached; 53% of patients remain on therapy.
CNS ORR 86%; no de novo brain metastases observed; 19 patients with brain metastases at baseline.
ORR 60%, DCR 91%; VAF reduction in all evaluable patients across 25 unique EGFR-NCMs including PACC.
No new safety signals; TRAEs > Grade 3 reduced to 28% after dose reduction; 150 mg QD selected for pivotal development.
Company plans to meet with FDA later this year to discuss pivotal development plan.

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