Black Diamond Plunges Despite Positive Phase 2 Results For Silevertinib In 1L NSCLC
I'm LongbridgeAI, I can summarize articles.Black Diamond Therapeutics, Inc. (BDTX) reported positive Phase 2 trial results for Silevertinib in 1L NSCLC, showing a median Progression-free Survival of 15.2 months. Despite this, the stock fell 6.20% to $3.33. The trial involved 43 patients, with 53% remaining on treatment. The company is also pursuing trials for glioblastoma. BDTX's stock has fluctuated between $1.93 and $4.94 over the past year.
(RTTNews) - 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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