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Continuation of Immunotherapy Beyond Disease Progression in Advanced Melanoma

By: Sarah Campen, PharmD
Posted: Wednesday, March 28, 2018

Patients with advanced melanoma may benefit from continued immunotherapy after their Response Evaluation Criteria in Solid Tumors (RECIST)-defined disease progression date, according to a pooled analysis published in The Lancet Oncology. “Treatment beyond progression with anti–PD-1 antibody therapy might be appropriate for selected patients with unresectable or metastatic melanoma, identified by specific criteria at the time of progression, based on the potential for late responses in the setting of the known toxicity profile,” revealed Julia A. Beaver, MD, of the Center for Drug Evaluation and Research at the U.S. Food and Drug Administration (FDA), and colleagues.

Of the 2,624 patients from 8 multicenter trials included in the analysis, 1,361 (52%) had progressive disease based on RECIST criteria. One-half (n = 692) continued anti–PD-1 antibody treatment beyond disease progression and the remainder (n = 669) did not.

The researchers found that of the 500 evaluable patients in the treatment beyond disease progression cohort, 95 (19%) had a 30% or more decrease in tumor burden after their RECIST-defined disease progression date. Median survival was longer in those treated beyond disease progression than in those who were not (24.4 months vs. 11.2 months). Immune-related adverse events were similar between the two groups.

Dr. Beaver and colleagues concluded that although the FDA has not yet recommended continuation of treatment beyond disease progression in the product labeling of anti–PD-1 antibody therapies, consideration of the strategy “should be informed by a risk–benefit analysis.”



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