Black Diamond Therapeutics to Present Phase 2 Silevertinib Data at 2026 ASCO Meeting

BDTX
April 22, 2026

Black Diamond Therapeutics will present oral and poster abstracts of its Phase 2 silevertinib data at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, scheduled for May 29 – June 2 2026.

The oral abstract, slated for May 30 2026, will detail safety and efficacy results of silevertinib in treatment‑naïve patients with non‑small cell lung cancer (NSCLC) harboring non‑classical EGFR mutations.

Poster abstracts on May 31 and June 1, 2026, will cover data in previously treated NSCLC patients and a randomized Phase 2 trial in newly diagnosed EGFRvIII‑positive glioblastoma (GBM).

This presentation marks the first public opportunity for Black Diamond to showcase the clinical activity and safety profile of its brain‑penetrant, fourth‑generation EGFR inhibitor, which targets over 50 non‑classical EGFR mutations in NSCLC and the EGFRvIII alteration in GBM. The company previously disclosed promising Phase 2 data in December 2025, showing a 60% objective response rate in frontline NSCLC patients.

Chief Medical Officer Dr. Sergey Yurasov said, "These highly encouraging data speak to the potential of silevertinib to be the treatment of choice for frontline NSCLC patients with the full spectrum of non‑classical EGFR mutations." President and CEO Mark Velleca added, "We are pleased to share these initial data in frontline patients showing silevertinib's activity against a broad spectrum of 35 distinct non‑classical EGFR mutations."

Investors have expressed optimism about the upcoming data, and the presentation will provide critical insight into Black Diamond’s competitive positioning in the rapidly evolving EGFR‑targeted oncology market. The company is also preparing to launch a randomized Phase 2 trial of silevertinib in newly diagnosed EGFRvIII‑positive GBM patients, expected to enroll approximately 150 patients and deliver preliminary results in 2028.

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