Black Diamond reports initial Phase 2 data for BDTX-1535 showing 42% ORR in recurrent EGFRm NSCLC

Black Diamond Therapeutics, Inc.

200 mg daily dose selected for pivotal development; favorable tolerability with no new safety signals.
Preliminary ORR of 42% (8/19) in patients with C797S or PACC osimertinib-resistance mutations; 14/19 remain on therapy.
Duration of response ~8+ months for first 3 partial responders; mean follow-up 4.7 months.
Regulatory feedback on registration path expected Q1 2025; initial first-line data expected Q1 2025.

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