Black Diamond Therapeutics, Inc. released topline data from its Phase 2 trial of silevertinib in frontline NSCLC patients with non-classical EGFR mutations.
The data showed robust anti-tumor activity with an ORR of 60% and an impressive CNS response rate of 86% in 43 patients.
The company also outlined plans for a randomized Phase 2 trial of silevertinib in newly diagnosed GBM patients.
Efficacy Data
60% Objective Response Rate (ORR) and 86% CNS ORR in 1L NSCLC patients.
Safety Data
No new safety signals observed, manageable adverse events included rash, stomatitis, and diarrhea.
Financial Status
Cash, cash equivalents, and investments of $135.5 million as of September 30, 2025, expected to fund operations into 2H of 2028.
Future Plans
Initiating a randomized Phase 2 trial in newly diagnosed GBM patients with initial data anticipated in 2028.
- Silevertinib demonstrated promising results in treating NSCLC patients with a variety of non-classical EGFR mutations.
- The high CNS response rate suggests potential for prolonged durability of response for patients with brain metastases.
The data presented by Black Diamond Therapeutics show the potential of silevertinib as a promising treatment option for NSCLC patients and highlight the company's strategic plans for further development in the GBM space.