Black Diamond Therapeutics has announced encouraging initial data from a Phase 1 study of BDTX-1535, an investigational fourth-generation EGFR MasterKey inhibitor. The trial targets patients with non-small cell lung cancer (NSCLC) and glioblastoma multiforme (GBM) with acquired and intrinsic driver EGFR mutations.

Key Findings from the Phase 1 Study of BDTX-1535

The study showed clinical proof of BDTX-1535’s efficacy in NSCLC patients. Partial response, confirmed by RECIST 1.1, was observed in 5 out of 12 NSCLC patients treated with predicted therapeutic doses. Another patient showed unconfirmed partial response, while six others exhibited stable disease.

BDTX-1535 exhibited a favorable tolerability profile, supporting its exploration in NSCLC expansion cohorts. Anticipated updates on the GBM cohort from the Phase 1 dose escalation data are due in Q4 2023.

BDTX-1535 Phase 1 Study Design and Initial Results

This first-in-human open-label clinical trial of BDTX-1535 involved dose escalation, followed by dose expansion cohorts. The study assessed the safety, pharmacokinetics, and preliminary anti-tumor activity of BDTX-1535 in adult patients with advanced/metastatic NSCLC or recurrent GBM expressing EGFR alterations.

As of May 20, 2023, 51 patients had been treated with BDTX-1535, exhibiting a linear increase in exposure and a half-life of approximately 15 hours. The drug was well-tolerated by NSCLC and GBM patients, and the overall safety profile was consistent with the EGFR tyrosine kinase inhibitor (TKI) class of drugs.

Promising Results Spur Further Investigation

Based on the data gathered, Black Diamond Therapeutics plans to commence enrollment at the BDTX-1535 200 mg daily dose in two expansion cohorts of NSCLC patients who had received up to two prior lines of therapy, including a third-generation EGFR TKI.

Upcoming Milestones for BDTX-1535

Black Diamond Therapeutics has outlined several significant milestones for BDTX-1535. These include the initiation of dose expansion cohorts in H2 2023, presentation of the full BDTX-1535 dose escalation data at a medical conference in Q4 2023, and a meeting with the FDA to discuss potential accelerated approval pathways for NSCLC in the same quarter. Furthermore, an update on the BDTX-1535 Phase 1 dose escalation data for recurrent GBM patients is expected in Q4 2023.

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