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Yale Cancer Center study shows new immunotherapy drug combination option to treat advanced melanoma

Wednesday, November 10, 2021

New Haven, CT — In new findings led by researchers at Yale Cancer Center and collaborating institutions, the monoclonal antibody drug sotigalimab, combined with the immunotherapy drug nivolumab, resulted in tumor shrinkage in patients with advanced melanoma whose tumors had progressed on prior immunotherapy. The drug combination also showed overall favorable outcomes for safety and tolerability. The results were reported today at the Society for Immunotherapy of Cancer (SITC) annual meeting.

“These findings are encouraging as we have discovered a new tool in our drug arsenal to treat patients with advanced melanoma,” said Harriet Kluger, MD, Professor of Medicine (Medical Oncology), Co-Director of the Yale Specialized Program of Research Excellence (SPORE) in Skin Cancer at Yale Cancer Center and senior author of the study. “Despite advances in developing therapies, immunotherapy resistance and tolerability are key problems for this patient population.”

Nivolumab blocks PD-1, a protein that helps keep immune cells from attacking non-harmful cells in the body. Nivolumab is already broadly used to treat melanoma and many other cancer types. Sotigalimab was designed to further stimulate antitumor immune response and to target CD40, which is a key co-stimulatory receptor.

Researchers enrolled 33 patients with advanced melanoma in this small, phase II study who were evaluable for response to therapy. Serious adverse events were reported in 15.8% of patients, although none were considered related to either sotigalimab or nivolumab. Five patients experienced tumor shrinkage, including four patients at Yale with durable responses who have now been off therapy for many months.

“These favorable results warrant further investigation,” said lead study author Sarah A. Weiss, MD. Weiss is a former Assistant Professor (Medical Oncology) at Yale Cancer Center and now affiliated with Rutgers Cancer Institute of New Jersey. “Sotigalimab’s activity and safety with nivolumab support a larger study and new study of combinations with other immuno-oncology therapeutics in other clinical settings.”

Funding for the study was provided by Apexigen.

Yale’s Mario Sznol, MD, was a contributing author on the study.


Yale New Haven Health (YNHHS), the largest and most comprehensive healthcare system in Connecticut, is recognized for advanced clinical care, quality, service, cost effectiveness and commitment to improving the health status of the communities it serves. YNHHS includes five hospitals – Bridgeport, Greenwich, Lawrence + Memorial, Westerly and Yale New Haven hospitals, several specialty networks and Northeast Medical Group, a non-profit medical foundation with several hundred community-based and hospital-employed physicians. YNHHS is affiliated with Yale University and Yale Medicine, the clinical practice of the Yale School of Medicine and the largest academic multi-specialty practice in New England. Yale New Haven Hospital is the primary teaching hospital of Yale School of Medicine.