Merck Announces First-Ever Phase III KEYNOTE-716 Data for Adjuvant Pembrolizumab in High-Risk Stage II Melanoma Post Complete Resection

ShanghaiSeptember 27, 2021 /PRNewswire/ -- MSD (MSD is a trade name of Merck & Co., Inc., Kenilworth, N.J., USA) first announced its PD-1 inhibitor pembrolizumab^[1]Phase III Clinical Trial KEYNOTE-716 Study Data for Adjuvant Therapy Following Complete Resection in Patients with High-Risk Stage II Melanoma. Pembrolizumab^[1]It is also the first PD-1 inhibitor to report such data.

“Through the KEYNOTE-716 study, we aimed to evaluate whether pembrolizumab as adjuvant therapy could prolong recurrence-free survival in patients with high-risk stage II melanoma following complete resection,” said Roy Baynes, M.D., Senior Vice President, Global Clinical Research, and Chief Medical Officer, MSD. “These data validate our investigative direction, and we are pleased that the findings have been granted priority review by the FDA. We sincerely thank all the investigators and enrolled patients who participated in this clinical trial.”

“Patients diagnosed with Stage IIB and IIC melanoma remain at a high risk of recurrence following complete surgical resection, and their five-year survival rates are comparable to those of patients with Stage IIIA and IIIB disease. However, due to the lack of available systemic treatment options, standard postoperative management for these patients is primarily observation.” Dr. Jason Luke, Director of the Center for Cancer Immunotherapy at UPMC Hillman Cancer Center, stated, “Based on the study data released from KEYNOTE-716, if regulatory approval is granted, it will provide these patients with a new treatment option.”

Data from the KEYNOTE-716 trial were presented at the ESMO Presidential Symposium and Press Conference (Abstract #LBA3). Early detection and diagnosis of cancer may provide patients with a greater opportunity for long-term survival benefits, and many cancers are considered most treatable and potentially curable at early stages. Building on the research progress of pembrolizumab in advanced cancers, MSD is conducting more than 20 registration clinical trials evaluating pembrolizumab for early-stage cancers.

To date, the indications for pembrolizumab approved by China's National Medical Products Administration (NMPA) are:

The indication for pembrolizumab as adjuvant therapy in patients with high-risk stage II melanoma following complete resection has not yet been approved by the NMPA.

^[1] As of now, the indication for pembrolizumab as adjuvant therapy following complete resection in patients with high-risk stage II melanoma has not yet been approved by the NMPA.