Black Diamond Therapeutics Presents Dose Escalation Data Demonstrating Durable Responses in Patients with NSCLC from Phase 1 Trial of BDTX-1535

Black Diamond Therapeutics, a clinical-stage oncology company, has announced promising results from its Phase 1 clinical trial of BDTX-1535 in patients with non-small cell lung cancer (NSCLC). BDTX-1535 is a fourth-generation, brain-penetrant epidermal growth factor receptor (EGFR) inhibitor that targets families of oncogenic mutations in genetically defined cancers.

The initial dose escalation results, presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, showed durable activity of BDTX-1535 in patients with NSCLC across heterogeneous EGFR mutation subtypes. The study included 27 patients with advanced/metastatic NSCLC who received doses ranging from 25mg to 400mg once daily.

The results demonstrated encouraging response durability, with BDTX-1535 achieving an objective response rate (ORR) of 52% and disease control rate (DCR) of 85%. Importantly, no new safety or tolerability signals were reported across the three active once daily doses of 100mg, 200mg, and 300mg.

“These results point to a highly active compound that has the potential to fill a substantial unmet need for an oral, well-tolerated precision therapy option in the current NSCLC therapeutic landscape for patients who progressed on a third-generation EGFR inhibitor,” said Dr. Helena Yu, Associate Attending Physician at Memorial Sloan Kettering Cancer Center.

The findings highlight the potential of BDTX-1535 as a treatment option for patients with NSCLC who have progressed on prior tyrosine kinase inhibitors (TKIs). Black Diamond Therapeutics is currently enrolling patients in expansion cohorts to evaluate BDTX-1535 at doses of 100mg and 200mg in patients with intrinsic driver and acquired resistance EGFR mutation-positive NSCLC. Initial results from this portion of the study are expected in 2024.

Dr. Sergey Yurasov, Chief Medical Officer of Black Diamond Therapeutics, emphasized the importance of BDTX-1535 in addressing the complex combination of mutations seen in NSCLC. He stated, “C797S is the most prevalent on-target resistance mutation, co-occurring with an increasingly heterogeneous set of other EGFR-acquired resistance mutations, intrinsic drivers, and classical drivers, highlighting the need for an agent like BDTX-1535.”

In addition to NSCLC, Black Diamond Therapeutics is also investigating BDTX-1535 in glioblastoma multiforme (GBM). Initial GBM dose escalation data is expected later this year.

The company 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.

Black Diamond Therapeutics is focused on developing MasterKey therapies that address families of oncogenic mutations in clinically validated targets. With its innovative approach and promising results, the company aims to provide effective treatment options for patients with genetically defined cancers.

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