Adjuvant treatment with mRNA-4157 (V940), an investigational individualized neoantigen therapy (INT), in combination with Keytruda (pembrolizumab) demonstrated a statistically significant and clinically meaningful improvement in distant metastasis-free survival (DMFS) for patients with resected high-risk melanoma (stage III/IV) in a phase IIb study.
FDA approved Keytruda (pembrolizumab) and Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) in combination with Padcev (enfortumab vedotin-ejfv), as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment, for the treatment of adult patients with muscle-invasive bladder cancer who are ineligible for cisplatin-based chemotherapy. These approvals represent the first PD-1 inhibitor plus ADC regimens for this patient population.
