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Immunotherapy, intralesional treatments, multidisciplinary care teams define rapidly-evolving multimodal approach.

What’s Ahead for Melanoma Management

Data shows that the overall rate of melanoma diagnosis rose sixfold over the last 4 decades at a time when melanoma mortality stayed relatively stable.

Study Reports Melanoma Overdiagnosis in White Patients  

The FDA has approved the fixed-dose combination of relatlimab plus nivolumab for the treatment of adult and pediatric patients who are 12 years of age or older and who have unresectable or metastatic melanoma.

FDA Approves Relatlimab Plus Nivolumab for Unresectable or Metastatic Melanoma

A phase 1 study of davoceticept and pembrolizumab for advanced malignancies received a partial clinical hold from the FDA following a patient death.

FDA Places Partial Clinical Hold on Phase 1 Trial of Davoceticept Pembrolizumab in Advanced Malignancies

The addition of bempegaldesleukin to nivolumab did not significantly improve progression-free survival, objective response rate, or overall survival vs nivolumab alone in the frontline treatment of patients with unresectable or metastatic melanoma, missing the primary end points of the phase 3 PIVOT IO-001 trial.

Frontline Bempegaldesleukin Nivolumab Combo Misses Primary End Points in Unresectable or Metastatic Melanoma

The FDA has accepted an investigational new drug application for the photoimmunotherapy treatment, RM-1995, for patients with advanced cutaneous squamous cell carcinoma or head and neck squamous cell carcinoma.


FDA Accepts IND for RM-1995 Photoimmunotherapy in Advanced Cutaneous or Head and Neck SCC

The European Medicines Agency has validated its marketing authorization application for the fixed-dose combination of relatlimab and nivolumab in the frontline treatment of adult and pediatric patients with advanced melanoma.

Relatlimab/Nivolumab Application for Frontline Advanced Melanoma Validated by EMA

Possible melanoma treatments have had multiple newsworthy events since July 2021.  

Pipeline Updates in Melanoma

Bristol Myers Squibb has announced that the FDA has accepted the Biologics License Application (BLA) for relatlimab and nivolumab, a fixed-dose combination treatment for unresectable or metastatic melanoma.  

FDA Accepts Priority Review for Melanoma Treatment

The FDA has granted priority review to a supplemental biologics license application for pembrolizumab for the use as an adjuvant treatment in adult and pediatric patients with stage IIB or IIC melanoma following complete resection.

FDA Grants Priority Review to Adjuvant Pembrolizumab for Stage II High-Risk Melanoma

Nemvaleukin alfa (Nemvaleukin) has been granted fast-track designation by the FDA for the treatment of patients with mucosal melanoma who have received prior treatment with an anti–PD-L1 therapy, according to a press release from Alkermes.

Nemvaleukin is an engineered interleukin-2 (IL-2) variant immunotherapy that was previously granted for orphan drug designation for mucosal melanoma.

Additionally, enrollment has begun for the global phase 2 ARTISTRY-6 (NCT04830124) trial, which will investigate the anti-tumor activity, safety, and tolerability of nemvaleukin alfa in patients with mucosal melanoma that have previously undergone treatment with anti-PD-L1 therapy.

"Receiving Fast Track designation from the FDA for nemvaleukin for the treatment of mucosal melanoma is an important milestone for the nemvaleukin development program and underscores nemvaleukin’s potential clinical utility to address an unmet medical need in this difficult-to-treat tumor type," Craig Hopkinson, MD, chief medical officer and executive vice president of research and development at Alkermes, said in a press release.

Investigators plan to enroll approximately 110 patients on ARTISTRY-6 trial , which is still currently recruiting. In this a non-randomized parallel assessment, patients with cutaneous melanoma with be treated with nemvaleukin subcutaneously every 7 days, and patients with mucosal melanoma with be treated with nemvaleukin intravenously for 30 minutes for 5 consecutive days.

The primary outcomes of this study are overall response rate assessed from 2 years after the first dose. Secondary end points are duration of response, progression-free survival, and disease control rate.

"We are committed to advancing this important research in mucosal melanoma, a rare and aggressive form of melanoma for which there are very limited treatment options, particularly for those patients previously treated with checkpoint inhibitors,” Hopkinson said.

A number of ARTISTRY trials are evaluating nemvaleukin both as a single agent and combination regimen across a number of tumor types. For example, investigators are currently using intravenous and subcutaneous doses of nemvaleukin in combination with anti–PD-1 therapy pembrolizumab (Keytruda) for patients with solid tumors.

This article was originally published by our sister publication 

1. Alkermes receives FDA fast track designation for nemvaleukin alfa for the treat of mucosal melanoma. News Release. Alkermes. August 2, 2021. Accessed August 2, 2021. 

2. Alkermes announces FDA orphan drug designation for nemvaleukin alfa for treatment of mucosal melanoma. News Release. Alkermes. March 11, 2021. Accessed August 2, 2021. 

Immunotherapy agent nemvaleukin alfa was granted an FDA fast track designation for the treatment of patient’s mucosal melanoma for previously undergone treatment with an anti-PD-L1 therapy.

FDA Grants Fast Track Designation to Nemvaleukin Alfa for Mucosal Melanoma

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