ALK-Vac Anti-Tumor Resistance Vaccine Shows Promise in ALK+ NSCLC
A prophylactic peptide vaccine (ALK‑Vac) targeting common ALK resistance mutations induces robust immune responses and appears safe and well tolerated in patients with advanced ALK‑positive NSCLC who have not progressed on standard‑of‑care TKI therapy.
In a phase 1b, single‑arm ARCHER trial (NCT05950139) of 15 patients with advanced or unresectable ALK‑positive NSCLC, the synthetic long‑peptide vaccine ALK‑Vac was administered concurrently with ongoing TKI therapy. 93 % of patients mounted CD4+‑enriched ELISpot responses to at least one target antigen and 33 % responded to all seven antigens; the most pronounced response was to the G1202R resistance mutation. No grade ≥3 toxicities or cytokine release syndrome were observed, and only one dose was held for a grade 2 neutropenia. One patient progressed after 8.5 months, but no vaccine‑targeted ALK resistance mutation emerged. These findings support feasibility and safety of a vaccine‑based strategy to intercept resistance neoantigens in oncogene‑driven cancers.
The data suggest a novel immunotherapeutic approach that may prevent the emergence of ALK‑mediated resistance, potentially prolonging disease control in a subset of patients with otherwise limited treatment options.
Bizonyítékszint: Korai humán adat. Kis vagy feltáró emberi adat.
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