--- title: "Black Diamond Plunges Despite Positive Phase 2 Results For Silevertinib In 1L NSCLC" type: "News" locale: "en" url: "https://longbridge.com/en/news/287329469.md" description: "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." datetime: "2026-05-22T08:20:32.000Z" locales: - [zh-CN](https://longbridge.com/zh-CN/news/287329469.md) - [en](https://longbridge.com/en/news/287329469.md) - [zh-HK](https://longbridge.com/zh-HK/news/287329469.md) --- # Black Diamond Plunges Despite Positive Phase 2 Results For Silevertinib In 1L NSCLC (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%. For More Such Biotech Stock News, visit rttnews.com. The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. ### Related Stocks - [BDTX.US](https://longbridge.com/en/quote/BDTX.US.md) - [IBB.US](https://longbridge.com/en/quote/IBB.US.md) - [XBI.US](https://longbridge.com/en/quote/XBI.US.md) - [BIB.US](https://longbridge.com/en/quote/BIB.US.md) - [ARKG.US](https://longbridge.com/en/quote/ARKG.US.md) - [PBE.US](https://longbridge.com/en/quote/PBE.US.md) - [SBIO.US](https://longbridge.com/en/quote/SBIO.US.md) - [FBT.US](https://longbridge.com/en/quote/FBT.US.md) - [LABU.US](https://longbridge.com/en/quote/LABU.US.md) - [BBH.US](https://longbridge.com/en/quote/BBH.US.md) - [NDAQ.US](https://longbridge.com/en/quote/NDAQ.US.md) ## Related News & Research - [Black Diamond Therapeutics Q2 net loss narrows year over year](https://longbridge.com/en/news/295007104.md) - [Analyst Reiterates Buy on Black Diamond Therapeutics, Citing Differentiated EGFR Inhibitor and Strong Cash Runway Through 2028](https://longbridge.com/en/news/285630631.md) - [Black Diamond Therapeutics Touts Silevertinib Lung Cancer Data, Eyes FDA Path](https://longbridge.com/en/news/288927469.md) - [Black Diamond Therapeutics Lung Cancer Drug Shows 15.2-Month PFS in Phase 2 Study](https://longbridge.com/en/news/287280796.md) - [Black Diamond Therapeutics (BDTX) Receives a Buy from TD Cowen](https://longbridge.com/en/news/279372551.md)