Melanoma & Skin Cancer

Paul D. Nathan, MBBS, PhD, FRCP, discusses the design of the phase 3 IMCgp100-202 trial of tebentafusp-tebn in patients with previously untreated, HLA-A*02:01–positive metastatic uveal melanoma, highlighting the key enrollment criteria of the randomized, open-label study.

Paul D. Nathan, MBBS, PhD, FRCP, discusses the rationale for launching the phase 3 IMCgp100-202 trial evaluating tebentafus in patients with previously untreated, HLA-A*02:01–positive metastatic uveal melanoma, as well as the mechanism of action of the agent.

Jeffrey S. Weber, MD, PhD, discusses the use of circulating-tumor DNA dynamics when guiding treatment decision-making in melanoma, according to data from the phase 2b mRNA-4157-P201/KEYNOTE-942 trial.

Omid Hamid, MD, director, Melanoma Program, The Angeles Clinic and Research Institute, Cedars-Sinai, discusses the rationale for a phase 1 trial of fianlimab plus cemiplimab in patients with advanced melanoma who have received prior adjuvant PD-1 inhibitors.

Elizabeth Buchbinder, MD, discusses the investigation of treatment with nivolumab maintenance therapy in patients with melanoma who experienced severe immune-related adverse effects associated with combination therapy with nivolumab and ipilimumab.

For patients with BRAF-mutant metastatic melanoma, doctors assess symptoms and disease status to determine if they should start treatment with combination immunotherapy, or 8-12 weeks of BRAF/MEK targeted therapy before switching to immunotherapy, which offers the possibility of durable responses or cure.

The panelists emphasize the importance of obtaining tissue for BRAF-mutation testing and dedicated tissue tracking in patients with metastatic melanoma, with immunohistochemistry followed by confirmatory next-generation sequencing, and discuss the promise of liquid biopsies like ctDNA as a future biomarker tracking modality.

The addition of bemcentinib to the standard-of-care therapies of pembrolizumab or dabrafenib plus trametinib was well tolerated in patients with metastatic melanoma; however, it did not lead to improvements in overall response rate, progression-free survival, or overall survival vs SOC alone.

Paul Nathan, MBBS, PhD, MRCP, discusses the differences between cutaneous melanoma and uveal melanoma that have led to unique unmet needs for patients with the latter malignancy; updated findings from the IMCgp100-202 trial; and how these findings may influence future clinical practice.

When a patient with metastatic melanoma patient tests negative for the BRAF V600E mutation, doctors recommend sending the sample for next-generation sequencing testing which can take 2-3 weeks, during which time they may start immunotherapy if the patient has aggressive disease, but ideally should wait for results to guide treatment.

Expert panelists stress the importance of biomarker testing for BRAF mutations to guide treatment options when a patient is diagnosed with metastatic melanoma.

Treatment with the novel immunotherapy PV-10 led to hepatic responses in patients with metastatic uveal melanoma with liver metastases, according to updated data from a phase 1 trial.

Paul D. Nathan, MBBS, PhD, FRCP, discusses the 3-year survival data from the phase 3 IMCgp100-202 trial of tebentafusp-tebn in patients with previously untreated, HLA-A*02:01–positive metastatic uveal melanoma.

Ze'ev Ronai, PhD, discusses key advancements in the treatment of patients with melanoma, including the discovery of NRAS and BRAF mutations, as well as the development of immunotherapy approaches.

Elizabeth I. Buchbinder, MD, discusses findings from a retrospective study evaluating the resumption of nivolumab maintenance therapy in patients with advanced melanoma who discontinued treatment with the combination of nivolumab and ipilimumab due to immune-related adverse effects.

Jeffrey S. Weber, MD, PhD, discusses findings from the phase 2b mRNA-4157-P201/KEYNOTE-942 trial of mRNA-4157 in combination with pembrolizumab in resected high-risk melanoma.

Neil D. Gross, MD, FACS, discusses 1-year follow-up data from a phase 2 study of neoadjuvant cemiplimab in cutaneous squamous cell carcinoma.

Meredith McKean, MD, MPH, discusses the efficacy and safety of treatment with the anti-TGIT agent etigilimab and the PD-1 inhibitor nivolumab in patients with solid tumors and PD-L1-low disease.

Danielle K. DePalo, MD, explains the lack of research directly comparing first-line treatment options for patients with unresectable melanoma in-transit metastases, expands on the safety and efficacy of 3 treatment modalities for these patients, and underscores the need for more data to inform the management of these patients.

The addition of mRNA-4157 to pembrolizumab led to clinically significant improvements in relapse-free survival and distant metastasis–free survival vs pembrolizumab alone in patients with high-risk resected melanoma.

Perioperative treatment with cemiplimab continued to produce signs of efficacy in patients with resectable stage II to IV cutaneous squamous cell carcinoma.

Lifileucel demonstrated clinically meaningful activity in patients with advanced mucosal melanoma who experienced disease progression on immune checkpoint inhibitors, according to findings from a subgroup of patients in the phase 2 C-144-01 study.

The 2023 ESMO Congress, which is taking place in Madrid, Spain, and will continue to be accessible online via a virtual platform, is gearing up to kick off, and the oncology community is ready to learn more about the latest data across malignancies.

Neoadjuvant treatment with intratumoral daromun led to a statistically significant and clinically meaningful improvement in recurrence-free survival compared with surgery alone in patients with locally advanced, fully resectable melanoma, meeting the primary end point of the phase 3 PIVOTAL trial.

The FDA has approved nivolumab (Opdivo) for the adjuvant treatment of adult and pediatric patients 12 years of age and older with completely resected stage IIB or IIC melanoma.

The FDA has extended the priority review period for the biologics license application seeking the approval of the tumor infiltrating lymphocyte therapy lifileucel for the treatment of patients with advanced melanoma who progressed on or after anti–PD-1/PD-L1 therapy and targeted therapy.

Inderjit Mehmi, MD, medical oncologist, discusses the rationale for investigating the combination of fianlimab and cemiplimab in patients who have advanced melanoma with poor-risk features

Brian Gastman MD, discusses how findings from CheckMate76K contributed to the rationale for a biomarker analysis in that trial’s patient population, key findings from this biomarker analysis, and how these findings may inform further research regarding the benefits of immunotherapy in earlier-stage disease.

Nicholas Coupe, MBBS, PhD, discusses the rationale for investigating IMM60 with pembrolizumab in patients with advanced melanoma or metastatic non-small cell lung cancer, as well as key background information that led to this investigation.

Varun Monga, MD, discusses the background for investigating the protein arginine methyltransferase 5 brain-penetrant inhibitor PRT811 in a phase 1 study in patients with recurrent high-grade glioma or uveal melanoma, as well as the agent’s mechanism of action.