Black Diamond reports Phase 1 topline data for BDTX-1535 in recurrent GBM; durable stabilization seen

Black Diamond Therapeutics, Inc.

22 evaluable patients: 3 on therapy >10 months, 1 >6 months, 5 >4 months; historical PFS is 2–4 months.
19 measurable disease patients: 1 confirmed partial response (200 mg QD) and 8 stable disease per RANO criteria.
No new safety signals; AEs were Grade 1–2 diarrhea and rash, consistent with EGFR TKI class.
One patient remains on 100 mg QD for >15 months after progression on temozolomide at 3 months.
Company plans to present dose escalation results at a medical meeting in Q2 2024; window-of-opportunity trial enrolling.

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