Halmos Highlights Evaluation of the EGFR Inhibitor BDTX-1535 in NSCLC

Welcome to OncLive On Air^®! I’m your host today, Courtney Flaherty.

OncLive On Air is a podcast from OncLive^®, which provides oncology professionals with the resources and information they need to provide the best patient care. In both digital and print formats, OncLive covers every angle of oncology practice, from new technology to treatment advances to important regulatory decisions.

In today’s episode, sponsored by Black Diamond Therapeutics, we had the pleasure of speaking with Balazs Halmos, MD, about the ongoing investigation of the potent, selective, and irreversible EGFR inhibitor BDTX-1535 in patients with non–small cell lung cancer (NSCLC). Dr Halmos is a professor of clinical medicine, the director of thoracic/head and neck oncology, and the director of clinical cancer genomics at Albert Einstein College of Medicine/Montefiore Medical Center in Bronx, New York.

The safety, tolerability, pharmacokinetics, and preliminary antitumor activity of the EGFR inhibitor BDTX-1535 are currently under investigation in the phase 1 BDTX-1535-101 trial (NCT05256290) in patients with recurrent glioblastoma or locally advanced or metastatic NSCLC with or without central nervous system (CNS) disease. The agent is being evaluated in both a dose-escalation portion and dose-expansion cohorts. Preliminary dose-escalation data from a subgroup of 12 patients with driver EGFR mutations were previously reported. In this subgroup, treatment with BDTX-1535 produced radiographically confirmed partial responses (PRs) in 5 patients. Responses were seen in patients with a range of common and uncommon EGFR alterations, including acquired EGFR C797S resistance mutations. One patient had an unconfirmed PR, while 6 patients achieved stable disease with the agent. Lastly, radiographic improvement in CNS metastasis was observed in 2 patients.

In our exclusive interview, Dr Halmos discussed BDTX-1535's unique design and ability to specifically target EGFR mutations; emphasized its potential to overcome both acquired and non-classical resistance mechanisms in patients with NSCLC; and highlighted its competitive position among other emerging therapies in this space.

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