Black Diamond Therapeutics Presents Real-World Treatment and Outcomes in New NSCLC Patients with Non-Classical Mutations at ESMO 2024

Black Diamond Therapeutics, Inc. recently presented an analysis of real-world treatment outcomes for patients newly diagnosed with non-small cell lung cancer (NSCLC) harboring non-classical EGFR mutations (NCMs) at the European Society for Medical Oncology (ESMO) Congress 2024 in Barcelona. This clinical-stage oncology company, listed on Nasdaq as BDTX, focuses on developing therapies to target oncogenic mutations in cancer patients.

The analysis examined treatment data from 3,276 cases of patients with newly diagnosed EGFR mutant NSCLC within the Guardant Health (GuardantINFORM™) clinical-genomic database. The findings reveal that a substantial proportion of these patients have NCMs, such as P-loop and αC-helix compressing (PACC) mutations. The study correlated these mutations with real-world treatment practices and outcomes, uncovering a broad spectrum of treatment variability.

In the study, 36% of patients with NCMs received osimertinib or afatinib, while 60% were treated with either chemotherapy or a combination of chemotherapy and immunotherapy. The results highlighted a clear unmet need for these patients, as evidenced by the short median time to treatment discontinuation. Patients treated with osimertinib had a median discontinuation time of six months, those on afatinib discontinued at a median of eight months, while chemotherapy-treated patients discontinued at a median of 4.2 months. This is in stark contrast to patients with classical EGFR mutations, who remained on osimertinib therapy for a median of 13.8 months.

Dr. John Heymach, Chair of Thoracic/Head and Neck Medical Oncology at MD Anderson Cancer Center, emphasized the need for new treatments for NSCLC patients with non-classical EGFR mutations. He pointed out that current EGFR TKIs are not significantly beneficial for these patients, and chemotherapy is associated with significant toxicity and limited efficacy.

Elizabeth Buck, Ph.D., Chief Scientific Officer and co-founder of Black Diamond Therapeutics, commented on the development of BDTX-1535, a fourth-generation EGFR TKI. This therapy is specifically designed to address a wide range of EGFR mutations, including non-classical mutations extending beyond PACC. BDTX-1535, described as the most advanced fourth-generation EGFR TKI in clinical development, aims to meet the unmet needs of this specific patient population.

The real-world results presented build on earlier findings from the 2024 American Association of Cancer Research (AACR) Annual Meeting, which highlighted the evolving landscape of EGFR mutations in NSCLC. The previous study revealed over 100 different non-classical mutations, present in 20-30% of newly diagnosed patients. Black Diamond Therapeutics plans to disclose initial Phase 2 data in the first quarter of 2025 for first-line NCM patients and will release further Phase 2 results later in the year for second and third-line settings.

Black Diamond Therapeutics is a company engaged in the clinical-stage development of MasterKey therapies, targeting a broad spectrum of genetically defined tumors. These therapies are designed to overcome resistance, minimize wild-type mediated toxicities, and be capable of penetrating the brain to treat central nervous system (CNS) diseases. The company’s key programs include BDTX-1535, aimed at EGFR mutant NSCLC and GBM, and BDTX-4933, targeting RAF alterations in solid tumors.