Merck's Pembrolizumab Receives Seventh Indication Approval in China for First-Line Treatment of MSI-H/dMMR Metastatic Colorectal Cancer

June 15, 2021 /PRNewswire/ -- MSD (known as Merck & Co., Inc., Kenilworth, New Jersey, U.S.A.) announced that pembrolizumab (brand name: KEYTRUDA®), a PD-1 inhibitor, has been approved by China's National Medical Products Administration (NMPA) as monotherapy for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC) with wild-type KRAS, NRAS, and BRAF genes. The approval of this new indication is based on data from the global pivotal Phase 3 KEYNOTE-177 clinical trial.

“In July 2018, pembrolizumab was approved for its first indication in China,To date, 7 indications have been successively approved across 5 cancer types,"...fully underscores our determination and commitment to actively introducing innovative medicines to benefit more patients in China," said Anna Tian, Senior Vice President, Global and President, China, MSD. "Colorectal cancer is the most common gastrointestinal cancer in China[1], and patients with MSI-H/dMMR have significant unmet treatment needs. The approval of this new indication will bring a new first-line treatment option for these patients with advanced disease."

According to World Health Organization data, there were approximately 555,000 new cases of colorectal cancer in China in 2020, ranking second only to lung cancer and representing the highest incidence among gastrointestinal tumors [1]. Due to the absence of obvious early symptoms, most patients are diagnosed at an intermediate or advanced stage [2], among which advanced colorectal cancer with MSI-H/dMMR carries a poorer prognosis [3].

Professor Shen Lin, Vice President of Peking University Cancer Hospital, Director of the Department of Gastrointestinal Oncology, and Deputy Director of the Beijing Cancer Research Institute, pointed out: “In clinical practice, MSI-H/dMMR is one of the prognostic indicators for colorectal cancer treatment [3], and patients with this advanced disease have long faced the dilemma of limited treatment options. With the advancement of immunotherapy in recent years, MSI-H/dMMR has emerged as an important biomarker for immunotherapy. The recent approval of pembrolizumab may potentially transform the first-line treatment landscape for this subset of advanced colorectal cancer in China.”

“Pembrolizumab is currently the only PD-1 inhibitor approved in China as monotherapy for the first-line treatment of advanced colorectal cancer with MSI-H/dMMR [4],” said Dr. Zhengqing Li, Senior Vice President and President of MSD China R&D Center. “Identifying biomarkers that can effectively select patients likely to benefit is a key exploratory direction in cancer immunotherapy. We will continue to advance research in this field to enable more patients to maximize the benefits of immunotherapy.”

References:

[1] IARC. China Fact Sheet (2020).

[2] National Health Commission of the People's Republic of China. Chinese Guidelines for Diagnosis and Treatment of Colorectal Cancer (2020 Edition). Chinese Journal of Surgery 8(2020):561-585.

[3] Xie Tongtong, Hu Jing, Yang Mi, et al. Research Progress on PD-1/PD-L1 in Clinical Trials for Patients with dMMR/MSI-H Colorectal Cancer[J]. Journal of Modern Oncology, 2019(5):885-888.

[4] This refers to unresectable or metastatic MSI-H/dMMR CRC with wild-type KRAS, NRAS, and BRAF genes. As of June 15, 2021, the National Medical Products Administration (NMPA) had no approval records for other drugs of the same class for this indication.

Executive Editor: Sanqi

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