Pembrolizumab immunotherapy can reduce the risk of distant metastasis by 36% in patients with operated on with high-risk relapse stage (IIB and IIC) melanoma, hitherto without treatment options.
This is evidenced by the Phase 3 KEYNOTE-716 study with pembrolizumab versus placebo in adjuvant (i.e. post-surgery) treatment.
The study was presented to the American Society of Clinical Oncology (ASCO) Congress.
"Patients with stage IIB and IIC melanoma have similar survival to that seen in stage IIIB patients, but unlike the latter, they have no systemic treatment options available and the standard of care so far has been represented by observation - says Paolo Ascierto, Director of the Melanoma Oncology Unit, Oncological Immunotherapy and Innovative Therapies of the Pascale National Cancer Institute of Naples -. With the KEYNOTE-716 study an important milestone has been reached because it has been shown that, even in these patients, Adjuvant immunotherapy with pembrolizumab for one year is able to improve not only relapse-free survival but also distant metastasis-free survival, a surrogate parameter of overall survival ".
Early phase immunotherapy, Ascierto concludes, "can in fact increase the number of patients who achieve recovery. In particular, the reduction in the risk of distant metastases was 36%, a very important figure".
Based on the results of the KEYNOTE-716 study, pembrolizumab received approval from the US regulatory agency (FDA) and a positive opinion from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use.
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