On April 21, 2026 Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with cancer, reported multiple presentations at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from May 29 – June 2, 2026, in Chicago.
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Details for the Oral Presentation:
Session Type/Title: Rapid Oral Abstract Session – Lung Cancer—Non-Small Cell Metastatic
Title: Safety and efficacy results of the phase 2 study of silevertinib (BDTX-1535) in treatment-naïve patients with non-small cell lung cancer with non-classical EGFR mutations
Abstract: 8519
Presenter: Julia Rotow, MD, Dana-Farber Cancer Institute
Date and Time: May 30, 2026, 1:15 PM-2:45 PM CDT (slides will be available at 8:00 AM EDT on the Black Diamond website here)
Details for the Poster Presentations:
Session Type/Title: Poster Session – Lung Cancer—Non-Small Cell Metastatic
Title: Safety and efficacy results of the phase 2 study of silevertinib (BDTX-1535) in previously treated patients with non-small cell lung cancer with non-classical and C797S EGFR mutations
Abstract: 8620
Poster Board: 410
Presenter: Helena Yu, MD, Memorial Sloan Kettering Cancer Center
Date and Time: May 31, 2026, 9:00 AM-12:00 PM CDT
Session Type/Title: Poster Session – Central Nervous System Tumors
Title: Randomized phase 2 study to evaluate the efficacy and safety of silevertinib in combination with temozolomide in newly diagnosed patients with EGFRvIII-positive IDHwt MGMT unmethylated glioblastoma
Abstract: TPS2098
Poster Board: 460a
Presenter: Patrick Wen, MD, Dana-Farber Cancer Institute
Date and Time: June 1, 2026, 1:30 PM-4:30 PM CDT
Posters will become available on June 1, 2026 at 8:00 AM EDT on the Black Diamond Therapeutics website here.
About Silevertinib
Silevertinib is an oral, covalent, brain-penetrant fourth-generation tyrosine kinase inhibitor (TKI) that selectively targets classical and more than 50 non-classical EGFR mutations in NSCLC. It also potently inhibits key EGFR alterations seen in GBM, including EGFRvIII, while avoiding the paradoxical EGFR activation reported with reversible TKIs. To date, over 200 patients with EGFR‑mutant NSCLC or EGFR‑altered GBM have been treated with silevertinib.
In December 2025 the Company disclosed initial data from the Phase 2 trial of silevertinib in frontline NSCLC patients harboring a broad spectrum of non-classical EGFR mutations which demonstrated a 60% Objective Response Rate (ORR by RECIST 1.1), 86% CNS ORR (by RANO-BM) and 91% disease control rate as of a November 3, 2025 data cutoff. No new safety signals were observed.
The Company is also initiating a randomized Phase 2 trial of silevertinib in patients with newly diagnosed EGFRvIII-positive GBM in the second quarter of 2026.
(Press release, Black Diamond Therapeutics, APR 21, 2026, View Source [SID1234664601])