Black Diamond Therapeutics Announces Positive Updated Silevertinib Phase 2 Results, FDA Feedback Supporting a Clear Path to Potential Registration in 1L EGFR-NCM NSCLC, and Provides Corporate Update
Key Highlights
- ➤86% CNS-ORR reported in 16 patients with untreated brain metastases
- ➤FDA feedback supports potential accelerated approval based on CNS-ORR
- ➤Phase 3 trial may begin Q2 2027, enrolling 300 patients with EGFR-NCMs
- ➤Cash, cash equivalents, and investments totaled $102.0 million; runway into second half of 2028
- ➤Q3 net loss widened to $10.0 million from $8.5 million year over year
Expert Statements
Alex Spira, M.D., Ph.D., Director of the Thoracic and Phase I Program at Virginia Cancer Specialists and Chief Scientific Officer of NEXT Oncology
“There remains significant unmet medical need in NSCLC patients with non-classical EGFR mutations, particularly in patients with brain metastases”
Alex Spira, M.D., Ph.D., Director of the Thoracic and Phase I Program at Virginia Cancer Specialists and Chief Scientific Officer of NEXT Oncology, and clinical investigator on the silevertinib Phase 2 trial
“Along with the exciting CNS response rate and progression free survival data from this Phase 2 trial, it is remarkable that not a single frontline patient treated with silevertinib has developed de novo brain metastases.”
Sergey Yurasov, M.D., Ph.D., Chief Medical Officer of Black Diamond Therapeutics
“Brain is the most common site of distant metastasis for patients with EGFR-mutant NSCLC”
Sergey Yurasov, M.D., Ph.D., Chief Medical Officer of Black Diamond Therapeutics
“We believe that silevertinib’s ability to significantly delay CNS progression is the key driver of the durable clinical benefit we are seeing in patients both with and without baseline brain metastases and is the foundation of the pivotal program design in 1L NSCLC.”
Mark Velleca, M.D., Ph.D., President and Chief Executive Officer of Black Diamond Therapeutics
“Our recent end of Phase 2 meeting with the FDA was highly collaborative, and we believe the feedback we received supports a clear path to potential accelerated and full approval for silevertinib in frontline NSCLC patients with EGFR non-classical mutations”
Mark Velleca, M.D., Ph.D., President and Chief Executive Officer of Black Diamond Therapeutics
“This trial design offers a differentiated path to potential accelerated approval in EGFR-NCM patients, who represent about 25% of the frontline EGFR mutant patient population.”
* Updated Phase 2 results demonstrate robust CNS activity, including 86% CNS-ORR and mPFS double that of currently available EGFR TKIs, in patients with untreated brain metastases * Recent End-of-Phase 2 meeting with the FDA supports pivotal development in all 1L EGFR-NCM NSCLC patients with potential for accelerated approval based on CNS-ORR * Cash, cash equivalents, and investments of $102.0 million as of September 30, 2026, is expected to be sufficient to fund operations into the second half of 2028 * Company to host an investor call today at 7:30am ET and will also participate in a fireside chat at the Stifel 2026 Healthcare Conference at 3:20pm ET CAMBRIDGE, Mass., Nov. 10, 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, including silevertinib, a potential best-in-class brain-penetrant epidermal growth factor receptor (EGFR) inhibitor, today reported updated data from its Phase 2 trial of silevertinib in frontline non-small cell lung cancer (NSCLC) patients with EGFR non-classical mutations (NCMs), the outcome from its End of Phase 2 meeting with the U.S. Food and Drug Administration (FDA) and associated Phase 3 plans, and financial results for the third quarter ended September 30, 2026.
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