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First successful phase 3 trial of a personalised mRNA cancer vaccine in melanoma (INTerpath-001)
The phase 3 INTerpath-001 trial met its primary endpoint of recurrence-free survival (RFS) and the key secondary endpoint of distant metastasis-free survival (DMFS) in 1,137 patients with completely resected stage IIB-IV cutaneous melanoma, randomised 2:1 to the personalised mRNA vaccine intismeran autogene (mRNA-4157) plus pembrolizumab or to pembrolizumab alone. The sponsors (Merck and Moderna) …
Generative AI in neoantigen cancer vaccine design — a review of promise and limits
A review published in Biotechnology Advances (1 September 2026) sets out where generative models can assist in designing therapeutic neoantigen cancer vaccines: tumour antigen discovery, ranking candidates by predicted immunogenicity, and assembling multi-epitope constructs. The authors also state why clinical efficacy of these vaccines remains constrained — imperfect antigen prioritisation, incom…
BRAF V600-mutant melanoma: adding spartalizumab to dabrafenib and trametinib extended median overall survival from 41.6 to 61.5 months in the final COMBI-i analysis
In the randomised phase 3 COMBI-i trial in unresectable or metastatic BRAF V600-mutant melanoma, adding spartalizumab (an anti-PD-1 antibody) to dabrafenib and trametinib yielded a final median overall survival of 61.5 months versus 41.6 months with placebo (HR 0.760; 95% CI 0.598-0.966; 267 vs 265 patients, median follow-up 76.9 months). Key caveat: the trial did NOT meet its primary endpoint of …
Intismeran Autogene Plus Pembrolizumab Versus Pembrolizumab Alone in High-Risk Resected Melanoma: 5-Year Update of the Randomized Phase IIb KEYNOTE-942 Study
The 5-year update of the randomized phase IIb KEYNOTE-942 study reports long-term outcomes for the individualized mRNA neoantigen vaccine intismeran autogene (mRNA-4157/V940) combined with pembrolizumab versus pembrolizumab alone in patients with completely resected high-risk melanoma. Earlier readouts had demonstrated a clinically meaningful reduction in recurrence risk with the combination, and …
The Moderna cancer vaccine offers hope — now we must speed up personalized therapies
A positive clinical trial of Moderna's personalized mRNA cancer vaccine (mRNA-4157/V940, in combination with pembrolizumab) has demonstrated promising results in treating cancer, reinforcing the therapeutic potential of individualized neoantigen vaccines. Nature's editorial emphasizes that while the trial data are encouraging, significant research and infrastructure challenges remain before person…
Oncolytic virotherapy RP1 plus nivolumab approved for anti-PD-1-refractory melanoma (ORR 32.9% in IGNYTE)
The FDA granted accelerated approval to vusolimogene oderparepvec (RP1, Tudriqev) combined with nivolumab for adults with unresectable advanced cutaneous melanoma that progressed on an anti-PD-1 antibody-based regimen — a group with very limited options. In the IGNYTE trial (Journal of Clinical Oncology, n=140, independent central review by RECIST 1.1) the confirmed objective response rate was 32.…
Moderna's personalised mRNA vaccine and melanoma recurrence: what the phase 2b trial actually showed, and what comes next
The personalised mRNA-4157 (V940) vaccine combined with pembrolizumab after complete resection of melanoma prolonged recurrence-free survival compared with pembrolizumab alone in the randomised phase 2b KEYNOTE-942 trial (Lancet 2024, n=157: 107 vs 50 patients). At 18 months, 79% of patients in the combination arm versus 62% on pembrolizumab remained recurrence-free (HR 0.561; 95% CI 0.309-1.017; …
Synergistic integration of regional and systemic therapies in uveal melanoma
A new review published in Nature Reviews Clinical Oncology examines the potential of combining percutaneous hepatic perfusion with immune-checkpoint inhibitors for metastatic uveal melanoma, a rare and aggressive eye cancer that frequently spreads to the liver. The authors synthesize recent evidence suggesting that this combination approach may improve patient outcomes compared to either strategy …
Improving immunotherapy in solid tumors using FMT
A paper in Cell describes faecal microbiota transplantation (FMT) as an addition to first-line immune checkpoint inhibitor therapy in renal cell carcinoma, cutaneous melanoma and non-small-cell lung cancer. The authors report improved efficacy with an acceptable safety profile and link it to remodelling of the gut microbiome and systemic immunometabolic changes. The available abstract gives neithe…