Black Diamond Therapeutics presents data from Phase 1 trial of BDTX-1535

Black Diamond Therapeutics presented results demonstrating response durability of BDTX-1535 in patients with locally advanced or metastatic non-small cell lung cancer. BDTX-1535, a fourth-generation, brain-penetrant epidermal growth factor receptor inhibitor, is under investigation in a Phase 1 clinical trial for patients with NSCLC or glioblastoma multiforme. The NSCLC results were disclosed in a poster presentation on October 14, 2023 at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston. The findings expand upon the initial dose escalation results disclosed on June 27, 2023, which showed anti-tumor activity of BDTX-1535 in patients with NSCLC across heterogeneous EGFR mutation subtypes. Data shared at the 2023 AACR-NCI-EORTC conference reflects 27 patients with advanced/metastatic NSCLC who received a range of doses spanning 25mg to 400mg once daily. Black Diamond is currently enrolling patients in the expansion cohorts evaluating BDTX-1535 at doses of 100mg and 200mg in patients with intrinsic driver and acquired resistance EGFR mutation positive NSCLC assessing objective response rate by RECIST 1.1. The company expects to share initial results from this portion of the study in 2024. Black Diamond also presented two additional posters outlining the study design of the ongoing Phase 1 clinical trial of BDTX-1535 in NSCLC and preclinical data for BDTX-4933, a brain-penetrant MasterKey RAF inhibitor targeting KRAS, NRAS and BRAF alterations in solid tumors.