Black Diamond Therapeutics' Silevertinib Shows 60% Response Rate in Preliminary Phase 2 Lung Cancer Data

Black Diamond Therapeutics Inc. (NASDAQ:BDTX) is one of the best biotech penny stocks to buy according to analysts. On December 3, Black Diamond Therapeutics announced significant clinical progress for silevertinib, which is the company’s MasterKey EGFR inhibitor. Preliminary Phase 2 data from 43 frontline/1L non-small cell lung cancer/NSCLC patients revealed a 60% objective response rate.

The study is particularly notable for addressing 35 different non-classical EGFR mutations, a diverse group of alterations that often resist standard therapies. As of the November 3 data cutoff, with a median follow-up of 7.2 months, the therapy also demonstrated a 91% disease control rate. A critical highlight of the trial is silevertinib’s high CNS penetration. Among patients with brain metastases, the drug achieved an 86% CNS response rate. This is a vital metric, as brain metastases are a primary driver of early disease progression in NSCLC patients.

Safety data remained consistent with previous findings; while the majority of patients experienced manageable side effects such as rash, diarrhea, and stomatitis, no new safety signals were observed. Updated results, including Progression-Free Survival and Duration of Response data, are expected in Q2 2026.

Using this strong CNS activity, Black Diamond Therapeutics Inc. (NASDAQ:BDTX) plans to initiate a randomized Phase 2 trial for newly diagnosed glioblastoma/GBM in H1 2026. GBM is a highly aggressive brain cancer where ~50% of the 7,000 annual US cases harbor EGFR alterations.

Black Diamond Therapeutics Inc. (NASDAQ:BDTX) is a clinical-stage oncology company that discovers and develops MasterKey therapies for patients with genetically defined tumors.

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Disclosure: None. This article is originally published at Insider Monkey.