Black Diamond Therapeutics, Inc. (BDTX) will host a webcast presentation on December 3, 2025, at 8:00 am ET to highlight results from its ongoing Phase 2 clinical trial of silevertinib in first-line non-small cell lung cancer (NSCLC) patients with non-classical epidermal growth factor receptor (EGFR) mutations.
The update will include objective response rate (ORR) and preliminary duration of treatment data from 43 patients enrolled in the study.
Silevertinib is a brain-penetrant, fourth-generation EGFR MasterKey inhibitor designed to target families of oncogenic mutations, overcome resistance, minimize wild-type mediated toxicities, and treat central nervous system diseases.
The program is currently advancing in three settings:
- First-line NSCLC with non-classical EGFR mutations: Silevertinib is being evaluated in a Phase 2 trial in newly diagnosed NSCLC patients. The company expects to seek FDA feedback on a potential registration path once progression-free survival (PFS) data become available in the first half of 2026.
- Second/ third-line NSCLC in C797S+ patients: A separate Phase 2 study is underway in NSCLC patients who have developed resistance through the C797S mutation. This program has received FDA Fast Track designation, underscoring its potential to address a high unmet need. Final Phase 2 data from this cohort are expected in the first half of 2026.
- Glioblastoma (GBM) with EGFR: Silevertinib is also being evaluated in glioblastoma, where EGFR alterations are common drivers of disease. An investigator-sponsored Phase 0/1 trial is ongoing in newly diagnosed patients, with initial pharmacodynamic (PD) data expected in the first half of 2026.
Black Diamond also continues to explore partnership opportunities to advance silevertinib in pivotal development in both NSCLC and GBM.
The company ended the third quarter of 2025 with $135.5 million in cash, cash equivalents, and investments, which it expects will be sufficient to fund operations into the fourth quarter of 2027.
BDTX closed yesterday's trading at $3.45, down 8.48%.
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