[EXAMPLE ARTICLE] Efficacy of Personalised mRNA Neoantigen Vaccines Combined with Anti-PD-1 Checkpoint Blockade in Advanced Non-Small Cell Lung Cancer: A Randomised Controlled Phase II Trial

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Personalised mRNA neoantigen vaccines represent a promising frontier in cancer immunotherapy, yet their efficacy in combination with programmed death-1 (PD-1) blockade has not been evaluated in a powered randomised trial for advanced non-small cell lung cancer (NSCLC).

We conducted an open-label, randomised controlled phase II trial across four academic centres in Singapore, the Netherlands, and Mexico.

Between March 2023 and January 2025, 148 patients were randomised (74 per arm). ORR at 24 weeks was 52.7% (39/74) in the combination arm versus 31.1% (23/74) in the control arm (OR 2.48; 95% CI 1.27–4.84; p = 0.008).

Personalised mRNA neoantigen vaccination combined with pembrolizumab significantly improved ORR and PFS compared with pembrolizumab alone in advanced NSCLC, with a manageable safety profile.