RegulatoryCompany release

Black Diamond outlines Phase 3 path for silevertinib after FDA End-of-Phase 2 meeting

🇺🇸 Black Diamond Therapeutics, Inc. (BDTX) · Tue 10 Nov 2026

Black Diamond Therapeutics reported updated Phase 2 silevertinib data in frontline EGFR non-classical-mutation NSCLC and FDA feedback on a Phase 3 programme that could support accelerated approval.

Black Diamond Therapeutics reported updated Phase 2 results on 10 November 2026 for silevertinib in first-line EGFR non-classical-mutation non-small cell lung cancer. In a small evaluable subset of patients with untreated brain metastases, the central nervous system objective response rate (CNS-ORR) was 86%.

The company also disclosed feedback from the US Food and Drug Administration following an End-of-Phase 2 meeting held on 1 October 2026. According to the company, the agency's comments cover a Phase 3 programme that could support accelerated approval on the basis of CNS-ORR and full approval on progression-free survival (PFS).

The FDA has also asked for safety data at the 150 mg dose before the Phase 3 trial can open. Black Diamond plans to start a global Phase 3 study in the second quarter of 2027.

On finances, Black Diamond reported cash of $102.0 million. It expects this to fund operations into the second half of 2028.

The 86% figure comes from a small subset of patients, so it should be read with caution. The summary available does not give the size of that subset or other detailed efficacy and safety results.

What it means for your team

  • The proposed design pairs an early intracranial endpoint (CNS-ORR) for accelerated approval with PFS for full approval, a structure other oncology sponsors may study.
  • The FDA's request for 150 mg safety data before the trial opens is a gating item that regulatory and clinical teams will want to track, as it bears on the Q2 2027 start.
  • The CNS-ORR result rests on a small evaluable subset, so confirmatory Phase 3 data will carry the weight for any labelling and market-access case.
  • The company's stated cash runway into the second half of 2028 would, on its own projection, cover the planned Phase 3 start.

Company's press release (SEC filing): Black Diamond Therapeutics, Inc. ↗

Article written by VigiEye from the official source (Black Diamond Therapeutics, Inc.). Claims are the company's own. AI-assisted; check the source before acting.

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