Updated phase 2 data showed a 60% ORR and 86% CNS ORR with frontline silevertinib in non-classical EGFR-mutant NSCLC; FDA discussion supported a phase 3 trial in 2027.
FDA issues a not approvable letter for Novocure’s Optune Mya in NSCLC brain metastases, citing uncertain clinical benefit. No safety concerns were raised.
Imneskibart showed promising outcomes and tolerability in patients who had previously received immune checkpoint inhibition for either melanoma or lung adenocarcinoma.
In KEYNOTE-867, adding pembrolizumab to radiotherapy did not extend event-free survival in inoperable early-stage NSCLC and raised toxicity; the phase 3 trial was stopped for futility in 2024.