Melanoma

Following the FDA approval of vusolimogene oderparepvec plus nivolumab, melanoma specialists are preparing for real-world clinical use while rethinking how to design future intratumoral therapy trials.

EIK1001, an agonist of TLR 7 and 8, is being investigated in first-line advanced melanoma in combination with pembrolizumab.

The tumor-infiltrating lymphocyte therapy has demonstrated potential for more convenient tissue collection and administration, an unmet need in advanced melanoma.

The FDA approved vusolimogene oderparepvec-wtpg plus nivolumab for PD-1–refractory advanced melanoma after a 10-3 advisory vote in favor of the oncolytic therapy.

Patients with advanced melanoma were treated with DOC1021, a dendritic cell vaccine.

FDA advisers back RP1 plus nivolumab for anti–PD-1–refractory advanced melanoma, citing durable responses despite design concerns and awaiting confirmatory IGNYTE-3 data.

The FDA's Cellular, Tissue, and Gene Therapies Advisory Committee is to determine whether data from the IGNYTE trial can support an accelerated approval of RP1 plus nivolumab.

Tucidinostat plus nivolumab extends progression-free survival in treatment-naive advanced melanoma, offering a promising oral, chemo-free boost to frontline immunotherapy.

During a live event, Sapna Patel, MD, and participants discussed second-line treatment selection for a patient with mucosal melanoma and considered how the limited available data shape that choice.

The clinicopathologic gene expression profile was granted the BDD status by the FDA for patients with T1b and T2a melanoma.

After 2 prior CRLs, the FDA accepted a resubmitted BLA as a complete class 1 response with a goal date of August 2, 2026 for the oncolytic therapy for melanoma.

During a live event, Sapna Patel, MD, discussed how to sequence second-line therapy for a patient with BRAF-mutant melanoma after immunotherapy and targeted therapy.

Five-year KEYNOTE-942 data show intismeran plus pembrolizumab delivers durable improvements in RFS and DMFS in high-risk resected melanoma.

The IGNYTE continues to show promising outcomes despite negative FDA decisions.

A combination regimen targeting LAG-3 and PD-1 did not significantly extend progression-free survival in advanced melanoma vs single-agent pembrolizumab.

The NEO-CYT trial began treating patients with melanoma in the perioperative setting, combining a novel agent with immune checkpoint inhibitor therapy.

First-in-class double-loaded patient-derived immunotherapy joins pancreatic cancer and glioblastoma in FDA Fast Track portfolio; phase 1/2 trial now recruiting.

The DNA ImmunoBody therapy improved efficacy when added to ipilimumab and nivolumab, with a registrational phase 3 trial expected to begin later this year.

With long-term follow-up, HLA-A*02:01–positive patients with metastatic uveal melanoma maintained survival benefit with the bispecific agent vs investigator's choice.

During a live event, participants discuss barriers to access and bridging strategies for tumor-infiltrating lymphocytes in melanoma.

mRNA-4359 demonstrated high response rates and antigen-specific T-cell activation in a small cohort of previously untreated patients.

Gut microbiome bacteria are linked to risk of recurrence after treatment with immunotherapy for resectable melanoma.

A brain-penetrant pan-RAF/MEK molecular glue demonstrated a 38% response rate in a heavily pretreated melanoma population that currently has no approved targeted therapies.

Oral darovasertib plus crizotinib doubled PFS and boosts responses in first-line HLA-A*02:01–negative metastatic uveal melanoma; FDA submission process is underway.

Lilit Karapetyan, MD, MS, discusses how a single-center trial suggests patients with poorer performance status could be eligible for tumor-infiltrating lymphocyte therapy.