Moderna and Merck (MSD) delivered positive Phase 3 results for INTerpath-001, showing that its AI-designed, patient-specific mRNA-lipid nanoparticle therapy intismeran (mRNA-4157/V940) added to pembrolizumab improved outcomes in stage IIB–IV cutaneous melanoma. The companies reported that the combination reduced melanoma recurrence, metastasis, and death compared with pembrolizumab alone. The trial enrolled more than 1,100 patients and used pembrolizumab as the control arm, with intismeran dosed as a bespoke therapy paired with the checkpoint inhibitor. Dosing was planned to continue unless patients met criteria for unacceptable toxicity. The readout arrives as regulators and developers grapple with how to evaluate personalization at scale, and whether machine-designed mRNA products can generalize beyond melanoma into other solid tumors.