Black Diamond's Lung Cancer Drug Shows 60% Response Rate In Phase 2 Data

Black Diamond Therapeutics, Inc. (NASDAQ:BDTX) released topline data on Wednesday from its Phase 2 trial of silevertinib in frontline (1L) non-small cell lung cancer (NSCLC) patients with non-classical epidermal growth factor receptor (EGFR) mutations (NCMs).

• BDTX stock is showing notable weakness. See what is driving the movement here.

All patients were enrolled at a 200mg oral daily dose of silevertinib. Efficacy and safety were assessed with a Nov. 3, 2025, data cutoff; median follow-up time as of this date was 7.2 months, and the study remains ongoing. Key data highlights include:

• 25 confirmed partial responses and one confirmed complete response

• 60% Objective Response Rate (ORR).

• 86% CNS ORR, and 91% disease control rate (DCR).

Also Read: Black Diamond Therapeutics Inks Licensing Pact With French Pharma Firm Servier For Its Early-Stage Cancer Drug Worth Over $700 Million

No new safety signals were observed. Adverse events (AEs) experienced by a majority of patients include rash, stomatitis, diarrhea, and paronychia.

The company expects to present updated results from the Phase 2 NSCLC trial, including Duration of Response (DOR) and Progression-free Survival (PFS) data in both the recurrent (83 patients) and frontline (43 patients) settings, at a medical meeting in the second quarter of 2026.

Black Diamond continues to explore potential partnerships to advance silevertinib into pivotal development.

GBM Program Update and Phase 2 Plans

Black Diamond plans to initiate a randomized Phase 2 trial in newly diagnosed glioblastoma (GBM) patients in the first half of 2026, with preliminary data expected in 2028.

The trial is expected to enroll approximately 150 newly diagnosed patients, randomized to receive TMZ (control arm) or silevertinib + TMZ (experimental arm)

Updated Financial Guidance

• Black Diamond previously reported cash, cash equivalents, and investments of approximately $135.5 million as of Sept. 30, 2025.
• The company now believes it is sufficient to fund its anticipated operating expenses and capital expenditure requirements into the second half of 2028.

Black Diamond Price Action: BDTX stock is down 23.77% at $2.62 at publication on Wednesday.

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