Aakash Desai, Associate Director, Phase 1 and Precision Oncology Program at UAB O’Neal Comprehensive Cancer Center, shared a post on LinkedIn:
“Silevertinib at ASCO26: Non-Classical EGFR Mutations Finally Get a Dedicated Targeted Therapy! Black Diamond Therapeutics
Rapid Oral Abstract presentation at American Society of Clinical Oncology (ASCO) 2026. Phase 2 results of silevertinib (BDTX-1535) in treatment-naive patients with non-classical EGFR-mutant NSCLC:
- ORR: 60%
- DCR: 91%.
- CNS ORR: 86%.
- Median PFS: 15.2 months.
Manageable safety profile with reduced Grade 3 AEs after dose optimization. (Note: dose reductions seemed to be important)
As an investigator on this trial UAB O’Neal Cancer Center, I’ve seen firsthand the unmet need these patients face. Non-classical EGFR mutations account for roughly 30% of all EGFR-mutant NSCLC that’s thousands of patients per year EGFR Resisters
What stands out:
The CNS data is exceptional. 86% CNS ORR with zero de novo brain metastases. For a population with high baseline CNS involvement, this level of intracranial activity is amazing.
Black Diamond Therapeutics built silevertinib using a mutation-to-medicine platform that maps drug sensitivity to specific EGFR structural variants. This is rational drug design meeting clinical execution.
The non-classical EGFR space has shifted from ‘too heterogeneous to target’ to ‘precision-targetable with the right drug design.’ Silevertinib proves the thesis.”
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