Black Diamond Therapeutics, Inc. (BDTX), a clinical-stage oncology company, announced positive results with 15.2 months of median Progression-free Survival from its Phase 2 trial of Silevertinib in frontline or 1L non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) non-classical mutations (NCMs).
Despite the news, BDTX is down 6.20% at $3.33 in the overnight market.
Company Details
Black Diamond Therapeutics develops therapies that target families of oncogenic mutations in patients with cancer.
The company is advancing Silevertinib, an investigational oral, covalent, brain-penetrant tyrosine kinase inhibitor (TKI) targeting EGFR-mutant NSCLC and glioblastoma (GBM).
The firm's development pipeline also includes BDTX-4933 and BDTX-4876.
Key Findings From Phase 2 Trial
43 patients with 1L NSCLC were enrolled in a 200 mg once-daily dose of Silevertinib, with a median follow-up of 11.2 months. Results as of an April 11, 2026, data cutoff date include the following,
-Preliminary median Progression-free Survival (mPFS) is 15.2 months and Median duration of response (DOR) has not yet been reached.
-More than half of patients (53%) remained on treatment, with the longest ongoing treatment duration reaching 23.5 months.
-Under CNS activity, the Objective Response Rate (ORR) by RANO-BM remained at 86%.ORR by RECIST 1.1 and Disease Control Rate (DCR) remained at 60% and 91%, respectively.
-Although no new safety signals were observed, the firm noted that the rate of Treatment-Related Adverse Events (TRAEs) of Grade 3 or greater decreased to 28% following dose reduction, and patients maintained clinical responses.
-Notably, safety and efficacy data support 150 mg once daily for pivotal development.
In addition to the ongoing Phase 2 trial of Silevertinib in patients with EGFRm NSCLC, the firm has also initiated a randomised Phase 2 trial of Silevertinib in patients with newly diagnosed EGFRvIII-positive GBM in May 2026.
BDTX has traded between $1.93 and $4.94 over the last year. The stock closed Thursday's trade at $3.55, down 1.39%.
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Business News
May 15, 2026 15:25 ET Apart from the confirmation of Kevin Warsh as the next Fed chair, the main news on the economics front this week included key price data from the U.S. and the first quarter economic growth figures from major economies. Both consumer prices and producer costs have started to reflect the effect of supply shocks due to the Middle East conflict. In Europe, GDP data was in focus, while inflation data from China dominated the news flow in Asia.