According to a press release by Merck & Co. issued on June 24, the European Commission has approved the use of adjuvant Pembrolizumab to treat resected stage IIB/C melanoma. “Adjuvant” refers to a therapy that is administered after cancer treatment in order to improve the outcome of the initial treatment.
Dr. Alexander Eggermont, chief scientific officer at Princess Máxima Center in the Netherlands, expressed his opinion that the approval confirms the importance of adjuvant therapy for patients who are twelve years of age and older. He emphasized that patients who have undergone a complete removal of stage IIB/C melanoma can now rely on a new treatment option with the potential to reduce their risk of having the cancer return. He explained that when melanoma returns or spreads (metastasizes), patients will have a worse long-term prognosis.
Further Regulatory Approval
Additionally, the European Commission extended its pembrolizumab approval to include advanced melanoma. The Commission expanded approval also for pembrolizumab as adjuvant therapy in cases of stage III melanoma where the tumors were fully resected.
The Commission’s findings were based on the results of NCT03553836, the two-part, placebo-controlled and randomized KEYNOTE-716 phase 3 study.
The study compared pembrolizumab against placebo in resected high-risk melanoma. Trial data showed that adjuvant pembrolizumab reduced the risk of cancer recurrence or death by 39 percent. The patients also experienced a significantly longer recurrence-free survival period.
There is a significant risk for a recurrence of melanoma after a patient has had a surgical resection. Unfortunately, the options for adjuvant treatment are limited. Although researchers have reported improved survival for high-risk melanoma patients, toxicity limits its use.
The FDA approved adjuvant pembrolizumab to treat fully resected stage IIB or IIC melanoma in December 2021.
Find out more in the full press release by Merck & Co. here.