Immunotherapy in Melanoma

Pembrolizumab led to sustained improvements in recurrence-free survival and distant metastasis–free survival vs placebo as adjuvant therapy in patients with resected stage IIB or IIC melanoma

Camrelizumab combined with famitinib elicited responses and was well tolerated in patients with advanced melanoma previously exposed to an immune checkpoint inhibitor regimen.

mRNA-4157 in combination with pembrolizumab improved recurrence-free survival compared with pembrolizumab alone when used as an adjuvant treatment in patients with resected high-risk melanoma, regardless of tumor mutational burden.

The addition of MEDI9253 to sequential or concurrent treatment with durvalumab failed to elicit more than 1 partial response although proving feasible and safe in patients with advanced or metastatic solid tumors, according to findings from a phase 1 trial.

The combination of nivolumab and relatlimab demonstrated clinical benefit with a manageable safety profile in patients with advanced melanoma who have progressed on prior PD-L1 or PD-1 inhibitors, regardless of PD-L1 and LAG-3 expression, according to findings from the ongoing phase 1/2a RELATIVITY-020 trial.

The combination of neoadjuvant vidutolimod and nivolumab elicited high response rates and was well tolerated in patients with high-risk, resectable melanoma, according to final results from a phase 2 trial.

The fixed-dose combination of relatlimab and nivolumab continued to demonstrate a consistent progression-free survival benefit, showcased a clinically meaningful improvement in overall survival, and elicited a higher objective response rate than nivolumab alone in previously untreated patients with metastatic or unresectable melanoma.

The FDA has approved pembrolizumab for the adjuvant treatment of adult and pediatric patients with stage IIB or IIC melanoma following complete resection.

Adjuvant pembrolizumab continued to showcase improved relapse-free survival over placebo in patients with resected high-risk stage II melanoma with 6 months of additional follow-up.

The universal cancer vaccine UV1 and granulocyte-macrophage colony-stimulating factor in combination with pembrolizumab elicited encouraging initial signs of clinical response with favorable safety and tolerability when used in the first-line treatment of patients with metastatic melanoma, meeting the primary end point of an ongoing phase 1 trial.

February 9, 2021 - The FDA has approved cemiplimab-rwlc as the first immunotherapy for use in patients with advanced basal cell carcinoma that has previously been treated with a hedgehog pathway inhibitor (HHI) or for whom a HHI is not appropriate.

January 25, 2021 - The FDA has granted toripalimab a fast track designation for use in the frontline treatment of patients with mucosal melanoma.

January 11, 2021 — The FDA has granted an orphan drug designation to the novel intratumoral immunotherapy agent PVSRIPO for the treatment of patients with advanced melanoma, specifically those with stage IIIB-IV disease.

Mario Sznol, MD, discusses the critical importance of being aware of the immune-related toxicities that could arise when treating patients with cancer, along with the best ways to manage them.

Douglas B. Johnson, MD, MSCI, discusses his research examining the impact of body composition on outcomes from anti–PD-1 with or without anti–CTLA-4 therapies in melanoma and other biomarkers under exploration.

Suthee Rapisuwon, MD, reviews management strategies under exploration for mucosal, acral, and uveal melanoma.

The immunotherapy combination of adjuvant nivolumab and ipilimumab failed to lead to a statistically significant improvement in recurrence-free survival in the intent-to-treat population of patients with resected stage IIIB/C/D or stage IV melanoma.

Michael B. Atkins, MD, discusses the clinical impact of key adjuvant and neoadjuvant data in the melanoma space, as well as the risks and benefits of both approaches.

Early findings from a phase II efficacy and safety study may be the first step in developing a definitive rationale for sequencing targeted therapies and immunotherapies in patients with metastatic melanoma.

Omid Hamid, MD, discusses emerging biomarkers in melanoma, data supporting their efficacy and their potential for use in clinical practice, and future directions for research.

A panel of experts discuss some of the encouraging data on emerging modalities in melanoma presented during the 2020 ASCO Virtual Scientific Program and share how they might apply that information to clinical practice.

As new data emerge in the melanoma treatment paradigm, new questions have come to light regarding neoadjuvant/adjuvant strategies, reduced dosing for immunotherapy combinations, and approaches following progression on, or resistance to, PD-1 inhibition.

The neoadjuvant combination of nivolumab and ipilimumab continues to demonstrate a benefit in RFS compared with the combination given in the adjuvant setting in patients with stage III macroscopic melanoma.

The use of adjuvant immunotherapy in patients with resected stage IIIC melanoma resulted in improved survival benefit, according to real-world data from an early analysis of the National Cancer Database.

Alexander Eggermont, MD, PhD, discusses the impact of the 3-year follow-up data from the phase 3 double-blind EORTC 1325/KEYNOTE-054 trial in high-risk stage III melanoma.

Axel Hauschild, MD, PhD, discusses the 5-year findings from the COMBI-AD trial.

In the phase 2 trial EMPOWER-CSCC-1, up to 3 years of follow-up showed continued response rates, and a clinically meaningful survival and duration of response for cemiplimab-rwlc in patients with advanced cutaneous squamous cell carcinoma.

The combination of encorafenib and binimetinib demonstrated continuing benefit in overall survival and progression-free survival for patients with BRAF V600–mutant melanoma.

Findings from a 5-year analysis of the phase 3 COMBI-AD trial validated the long-term benefit of adjuvant dabrafenib and trametinib in patients with resected, stage III BRAF V600E/K-mutant melanoma.

AMG 510, a novel KRAS G12C inhibitor, demonstrated early evidence of a consistent safety profile and anticancer activity across a range of advanced KRAS G12C-mutant solid tumors other than non–small cell lung cancer and colorectal cancer.