Skin Cancer & Melanoma

The FDA indicated that data from the phase 1/2 IGNYTE trial were not adequate to provide evidence of effectiveness.

The B7-H3–low and TIGIT-high biosignatures correlated with superior event-free survival outcomes in those with melanoma treated with the combination.

ATR04-484 showed inhibition of both methicillin-sensitive and methicillin-resistant Staphylococcus aureus bacteria strains, which are associated with rash.

Phase 3 data demonstrate the potential utility of BRAF/MEK inhibition in the adjuvant setting for patients with stage IIB/IIC BRAF V600–mutant melanoma.

A phase 3 trial evaluating frontline IFx-2.0 with pembrolizumab in advanced/metastatic Merkel cell carcinoma is planned to start later in June 2025.

Data from the IGNYTE trial demonstrate the development of a robust systemic antitumor response following treatment with RP1.

Compared with nivolumab alone, nivolumab/relatlimab did not improve RFS in patients with resected stage III to IV melanoma.

The combination elicited a clinical benefit rate of 63.0% and an overall response rate of 22.2% in anti–PD-L1–refractory melanoma with melanoma brain metastases.

Efficacy across most patient subgroups appeared to be consistent with relatlimab/nivolumab vs ipilimumab/nivolumab in patients with advanced melanoma.

No treatment-related deaths were observed among patients with metastatic uveal melanoma treated with melphalan and a hepatic delivery system.

The combination of nurulimab plus prolgolimab enhanced PFS, ORR, and DCR compared with prolgolimab monotherapy in unresectable or metastatic melanoma.

ctDNA levels may help to predict early recurrence for patients with stage III melanoma before adjuvant therapy and during follow-up.

All patients identified as low risk for sentinel lymph node positivity with the DecisionDx-Melanoma test had recurrence-free status after 3 years.

Ahmad Tarhini, MD, PhD, and Hussein A. Tawbi, MD, PhD, discussed data from the RELATIVITY-047 and CheckMate 076 trial for patients with melanoma.

Data from RELATIVITY-047 show consistent benefits with nivolumab/relatlimab across most patient subgroups, including those with BRAF-mutated disease.

The safety profile of nivolumab plus relatlimab in patients with stage III/IV melanoma was consistent with the known profiles for each individual agent.

The phase 1/2 KEYMAKER-U02 trial evaluating pembrolizumab alone or as a combination therapy in stage IIIB-D melanoma found no adverse event–related deaths.

RP1 with nivolumab elicited an ORR of 38.7% with an acceptable safety profile in patients with advanced melanoma who progressed on anti–PD-1 therapy.

Investigators of the phase 3 C-POST trial will continue to follow up with patients and assess the key secondary end point of overall survival.

The CheckMate 067 trial found that, at a 10-year follow-up, nivolumab/ipilimumab elicited a median OS of 71.9 months in patients with previously untreated, advanced melanoma.

Cosibelimab has been approved by the FDA as a treatment for patients with cutaneous squamous cell carcinoma.

Vusolimogene oderparepvec in combination with nivolumab has received breakthrough therapy designation from the FDA in advanced melanoma.

Phase 1 data highlight a manageable safety profile with IMA203 among patients with melanoma and other PRAME-positive solid tumors.

Phase 3 data may support the photodynamic therapy as a noninvasive treatment option for patients with superficial basal cell carcinoma.

Phase 1b findings may affirm the therapeutic potential of IMA203 for patients with previously treated metastatic melanoma.

The safety profile of fianlimab/cemiplimab in a phase 1 trial was consistent with prior reports of cemiplimab monotherapy.

Phase 2 data also show responses with atezolizumab switch therapy in a population of patients with BRAF V600–positive melanoma.

Support for the planned biologics license application comes from data showing a 32.9% response rate with RP1 plus nivolumab for melanoma.

Support for the decision follows phase 1 findings evaluating IBI363 in patients with advanced solid tumors presented at the 2024 ESMO Plenary.

Preliminary results from part 2 of the phase 2 trial evaluating VP-315 in basal cell carcinoma found no dose-limiting toxicities or treatment-related serious adverse events.