- Poster also to be presented on the Phase 2 data of silevertinib in recurrent EGFRm NSCLC patients
- Trial-in-progress poster to be presented on the randomized Phase 2 trial of silevertinib in patients with newly diagnosed EGFRvIII-positive GBM
CAMBRIDGE, Mass., April 21, 2026 (GLOBE NEWSWIRE) -- Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with cancer, today announced multiple presentations at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting from May 29 – June 2, 2026, in Chicago.
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.
About Black Diamond Therapeutics
Black Diamond Therapeutics is a clinical-stage oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with cancer. The Company’s MasterKey therapies are designed to address a broad spectrum of genetically defined tumors, overcome resistance, minimize wild-type mediated toxicities, and be brain penetrant to treat central nervous system disease. The Company is advancing silevertinib, a brain-penetrant fourth-generation EGFR MasterKey inhibitor targeting EGFR-mutant NSCLC and GBM. For more information, please visit www.blackdiamondtherapeutics.com.
From time to time, we may use our website or our LinkedIn profile at www.linkedin.com/company/black-diamond-therapeutics to distribute material information. Our financial and other material information is routinely posted to and accessible on the Investors section of our website, available at www.blackdiamondtherapeutics.com. Investors are encouraged to review the Investors section of our website because we may post material information on that site that is not otherwise disseminated by us. Information that is contained in and can be accessed through our website or our LinkedIn page is not incorporated into, and does not form a part of, this press release.
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding: the continued development and advancement of silevertinib, including the ongoing Phase 2 clinical trial and the timing of clinical updates for silevertinib in patients with NSCLC and in patients with GBM, expectations regarding the planned initiation of a randomized Phase 2 trial of silevertinib in patients with newly diagnosed EGFR-altered GBM, the potential of silevertinib to address the unmet medical need for newly diagnosed NSCLC patients with non-classical EGFR mutations and benefit patients with NSCLC across multiple lines of therapy, and the potential future development plans for silevertinib in NSCLC and GBM. Any forward-looking statements in this press release are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking statements include those risks and uncertainties set forth in its Annual Report on Form 10-K for the year ended December 31, 2025, filed with the United States Securities and Exchange Commission and in its subsequent filings filed with the United States Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
Contact
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