Apr. 21 at 4:26 PM
$BDTX
Excerpt👇
Silevertinib is an oral, covalent, brain-penetrant fourth-generation tyrosine kinase inhibitor (TKI) that selectively targets classical and more than 50 non-classical EGFR mutations in NSCLC. It also potently inhibits key EGFR alterations seen in GBM, including EGFRvIII, while avoiding the paradoxical EGFR activation reported with reversible TKIs.
In December 2025 the Company disclosed initial data from the Phase 2 trial of silevertinib in frontline NSCLC patients harboring a broad spectrum of non-classical EGFR mutations which demonstrated a 60% Objective Response Rate (ORR by RECIST 1.1), 86% CNS ORR (by RANO-BM) and 91% disease control rate as of a November 3, 2025 data cutoff. No new safety signals were observed.
The Company is also initiating a randomized Phase 2 trial of silevertinib in patients with newly diagnosed EGFRvIII-positive GBM in the second quarter of 2026.
What’s not to like, seems risk worthy✌️
