In the first installment of the series, Allison Betof Warner, MD, PhD, reviews the mechanistic rationale behind tumor-infiltrating lymphocytes and considers where these experimental therapies may fit in the oncologic landscape.
FDA issues a not approvable letter for Novocure’s Optune Mya in NSCLC brain metastases, citing uncertain clinical benefit. No safety concerns were raised.
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.
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.