Black Diamond Therapeutics Reports Positive Phase 2 Results for Silevertinib

CAMBRIDGE, Mass., Nov. 10, 2026 /CourierPR/ -- Black Diamond Therapeutics, a clinical-stage oncology company, has announced positive updated results from its Phase 2 trial of silevertinib, an investigational oral, covalent, brain-penetrant fourth-generation tyrosine kinase inhibitor (TKI) targeting EGFR mutations in non-small cell lung cancer (NSCLC) and glioblastoma (GBM). The trial demonstrated robust central nervous system (CNS) activity, with an 86% CNS objective response rate (CNS-ORR) and a median progression-free survival (mPFS) double that of currently available EGFR TKIs in patients with untreated brain metastases.

The company also received positive feedback from the U.S. Food and Drug Administration (FDA) following an End-of-Phase 2 meeting, supporting a clear path to potential registration in first-line (1L) EGFR non-classical mutations (NCM) NSCLC patients. The FDA indicated that silevertinib's ability to significantly delay CNS progression is the key driver of the durable clinical benefit observed in patients, both with and without baseline brain metastases. 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.

As of an October 7, 2026, data cutoff date, with a median patient follow-up of 15.9 months, updated results from the Phase 2 trial of silevertinib dosed at 200 mg once daily (QD) in 43 frontline NSCLC patients harboring a broad spectrum of EGFR NCMs were as follows:

- Intention to Treat (ITT) Population: n=43 - 60% overall response rate (ORR) (RECIST 1.1), 93% disease control rate (DCR) - 15.0 month median progression-free survival (mPFS) (95% confidence interval (CI): 11.0, 23.5) - 18 patients remained on therapy, with the longest at 26.2 months

For patients with untreated brain metastases (n=16, 7 evaluable by Response Assessment in Neuro-oncology - Brain [RANO-BM]): - 86% CNS-ORR (RANO-BM) - 12.2 months systemic mPFS (95% CI: 8.1, not estimable (NE)) by RECIST 1.1

For patients without brain metastases (n=24): - 23.5 months mPFS (95% CI: 11.0, not estimable (NE)) - No patients with progression in the brain

The company is planning a global Phase 3 registrational trial of silevertinib in frontline NSCLC patients with EGFR-NCMs, with the potential to initiate in the second quarter of 2027. This trial would enroll 300 patients with EGFR-NCMs and untreated brain metastases, randomized 1:1 to receive silevertinib 150 mg once daily or physician’s choice of osimertinib or afatinib. The primary endpoints are CNS-ORR (RANO-BM by Blinded Independent Central Review [BICR]) for potential accelerated approval and systemic PFS (RECIST 1.1 by BICR) for potential full approval. The Phase 3 trial would also include an additional 80 patient single-arm cohort in frontline NSCLC patients with EGFR-NCMs without brain metastases, and a 20 patient single-arm cohort in patients with leptomeningeal disease. Assuming a second quarter of 2027 initiation, preliminary data are anticipated in 2028.

Black Diamond Therapeutics ended the third quarter of 2026 with approximately $102.0 million in cash, cash equivalents, and investments, sufficient to fund operations into the second half of 2028. The company is also conducting a randomized Phase 2 trial of silevertinib in patients with newly diagnosed EGFRvIII-positive GBM, with the first patient dosed in the fourth quarter of 2026.

The company will host an investor call today at 7:30am ET and will participate in a fireside chat at the Stifel 2026 Healthcare Conference at 3:20pm ET.