Double "new evidence" support! Good news for melanoma patients!

At the just-concluded 2024 European Society for Medical Oncology (ESMO) Annual Meeting, pembrolizumab announced the longest 10-year overall survival follow-up data to date. Using pembrolizumab as the first-line treatment, 34.0% of patients with advanced melanoma survived for 10 years or more. Last week, pembrolizumab was approved by the China National Medical Products Administration (NMPA) for the first-line treatment of unresectable or metastatic melanoma. Chinese melanoma patients received two good news at the same time.

Source: National Drug Administration official website

"With this approval, pembrolizumab will once again bring new treatment options to more melanoma patients," said Anna Tien, global senior vice president of Merck and president of Merck China. "From the first indication approved in China in 2018, which was second-line treatment for advanced melanoma, to the current expansion of its applicability to first-line treatment, it fully demonstrates our persistent efforts and commitment to exploring more groundbreaking innovative treatment options, creating an era in which cancer can be treated and potentially cured for patients."

Melanoma is the result of malignant proliferation of melanocytes. In my country, the age-standardized incidence of melanoma is about 0.37/100,000, which is a rare malignant tumor. In 2022, there will be about 8,800 new cases of skin melanoma and about 5,400 deaths in my country.

"Melanoma is one of the cancers that is difficult to treat effectively. In China, most melanomas have already developed to the middle and late stages when diagnosed. With the approval of multiple PD-1 inhibitors in China in 2018, tumor immunotherapy has become one of the recommended therapies for second-line and above salvage treatment of advanced melanoma in China." Professor Guo Jun of Peking University Cancer Hospital said, "We are very pleased to see that pembrolizumab will likely bring new options and hope to more patients with advanced melanoma."

"Whether globally or in China, the first indication of pembrolizumab is in the field of melanoma treatment, opening up new treatment options for cancer patients," said Dr. Zhengqing Li, senior vice president of Merck and president of China R&D Center . "On the 10th anniversary of the global approval of pembrolizumab, we are very pleased to see the new indication for the first-line treatment of advanced melanoma approved in China, which once again demonstrates our leading position in the field of tumor treatment. We will continue to explore and innovate treatment options to benefit more cancer patients."

Overall survival is a true record of the time from the start of treatment to the death of a patient. It can most directly reflect the patient's final survival and is considered the gold standard for evaluating the efficacy of tumor drugs. The KEYNOTE-006 study is one of the earliest clinical studies to evaluate the efficacy of melanoma immunotherapy and is also the longest clinical study to date on the overall survival of patients with advanced melanoma. The follow-up results of this study show that the survival status of melanoma patients has continued to improve in recent years.

In 2023, the 7-year follow-up data released by the KEYNOTE-006 study showed that pembrolizumab continued to significantly prolong the overall survival of patients. Patients who received pembrolizumab as first-line treatment reduced their risk of death by 37%, and 41.2% of patients lived for more than 7 years. Among patients who received pembrolizumab for ≥ 94 weeks and achieved disease stability, 92.9% of patients survived for 5 years or more.

At this year's ESMO Annual Meeting, the KEYNOTE-006 study released the latest 10-year follow-up survival data. The results showed that among patients treated with pembrolizumab, 34.0% of patients could survive for more than 10 years. Among patients who received pembrolizumab for ≥ 94 weeks and achieved disease stability, 80.8% of patients could live to or exceed 8 years.

To date, pembrolizumab has been approved for 14 indications in China, covering the treatment of melanoma, lung cancer, esophageal cancer, colorectal cancer, head and neck cancer, gastric cancer, liver cancer, breast cancer, biliary tract cancer and MSI-H solid tumors.