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May 13, 2026
Tumour-infiltrating lymphocyte therapy has shown durable responses in refractory melanoma, including a 31.4% objective response rate in phase II data. The 2024 FDA approval of Lifileucel marked a milestone as regulators in other markets continue reviews.
May 05, 2026
Intravenous and subcutaneous nivolumab in advanced melanoma had similar safety profiles, with no major differences in systemic side effects. The main distinction was mild, manageable injection site reactions with subcutaneous administration.
Apr 12, 2026
Iovance reported real-world data suggesting Amtagvi may have a best in class profile in advanced melanoma. The company posted $263.5 million in annual sales after 2024 approval, while pursuing broader use and facing regulatory and logistics risks.
Apr 11, 2026
Replimune said the FDA issued a complete response letter for its RP1 plus nivolumab application in advanced melanoma. The company disputed the agency’s assessment and said it will cut jobs and scale back U.S. manufacturing.
Apr 09, 2026
The FDA accepted Replimune’s BLA resubmission for RP1 plus nivolumab in advanced melanoma. The agency set an April 10, 2026 PDUFA date under a Class II resubmission timeline.
Mar 13, 2026
Decreases in circulating tumor DNA within 3-4 weeks of immune checkpoint inhibitor therapy were strongly associated with higher response rates and longer survival in patients with unresectable stage III/IV melanoma, according to a multi-institutional retrospective analysis.
Mar 12, 2026
Study finds advanced melanoma patients with sufficient vitamin D levels showed better response rates and longer survival when receiving anti-PD-1 immunotherapy compared to those with low vitamin D status.
Feb 27, 2026
Neoadjuvant pembrolizumab achieved 71% pathologic complete response in desmoplastic melanoma patients, while lower-dose ipilimumab combination therapy showed improved survival and fewer side effects in advanced melanoma treatment.
Feb 26, 2026
Iovance Biotherapeutics reported Q4 2025 revenue of $87 million, beating estimates, while receiving FDA fast-track designation for lifileucel in non-small cell lung cancer and reporting strong sarcoma trial data.
Feb 26, 2026
Lynch syndrome patients gain access to prevention vaccines in clinical trials, while immunotherapy advances depend on universal tumor testing for microsatellite instability. Cancer vaccines are moving from research to clinical reality.
Feb 24, 2026
A first-in-human trial shows individualized neoantigen mRNA vaccines generated multi-year T cell responses in early-stage TNBC patients, with 82.9% of targeted mutations eliciting measurable immune activation not detectable before vaccination.
Feb 24, 2026
Replimune Group Inc. approaches a critical regulatory milestone as the FDA is scheduled to decide on its RP1 melanoma therapy by April 10, 2026, with cash reserves extending into early 2027.
