Merck's Keytruda for First-Line Treatment of Colorectal Cancer Nominated for Priority Review in China

On November 12, the latest public notice on the website of the Center for Drug Evaluation (CDE) under China’s National Medical Products Administration indicated that pembrolizumab injection (Keytruda), a PD-1 inhibitor from MSD, is proposed to be included in the priority review program as a drug eligible for conditional approval, with the proposed indication being first-line treatment for colorectal cancer. According to information on the CDE website, all six new drug marketing applications previously submitted for pembrolizumab in China had been formally included in the priority review program.

Source: CDE Official Website

Pembrolizumab is a blockbuster PD-1 inhibitor developed by MSD. It enhances the body’s immune response against cancer by blocking the PD-1/PD-L1 signaling pathway. Previously, this product has been approved in China for multiple indications, including melanoma, squamous and non-squamous non-small cell lung cancer (NSCLC), PD-L1-positive NSCLC, and esophageal squamous cell carcinoma. In addition, the new drug application for pembrolizumab as first-line monotherapy for patients with specific recurrent head and neck squamous cell carcinoma (HNSCC) was included in the priority review program in July this year and is currently under regulatory review and approval.

Pembrolizumab is proposed for inclusion in the priority review pathway in China, with the proposed indication being first-line treatment of colorectal cancer. According to public information, pembrolizumab received approval in the United States at the end of June this year for an expanded indication in colorectal cancer. Specifically, it is approved for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) colorectal cancer.

According to an earlier press release issued by the U.S. FDA, this approval makes pembrolizumab the first first-line immunotherapy approved for this patient population without the need for combination with chemotherapy. Meanwhile, it is also the first first-line immunotherapy approved based on the MSI-H or dMMR biomarkers, representing another breakthrough in the use of molecular biological markers for patient selection.

It is reported that the FDA’s approval of this indication was based on the results of a multicenter, open-label, randomized trial with an active comparator. The study enrolled a total of 307 patients with metastatic colorectal cancer (mCRC) characterized by microsatellite instability-high (MSI-H) or mismatch repair deficiency (dMMR). The results demonstrated that patients treated with pembrolizumab achieved a significantly improved progression-free survival (PFS), with a median PFS of 16.5 months versus 8.2 months in the standard-of-care group. Compared with chemotherapy, pembrolizumab reduced the risk of disease progression or death by 40%.

Advanced colorectal cancer is a common and highly prevalent malignant tumor worldwide. According to statistics, there are approximately 1.36 million new cases annually, with nearly 700,000 deaths, posing a significant challenge to humanity. In China, the number of new cases each year is 376,000.

References:

[1] Center for Drug Evaluation, National Medical Products Administration of China. Retrieved Nov 12, 2020, from http://www.cde.org.cn/news.do?method=changePage&pageName=service&frameStr=21#

[2] FDA Approves First-Line Immunotherapy for Patients with MSI-H/dMMR Metastatic Colorectal Cancer. Retrieved June 29, 2020, from https://www.fda.gov/news-events/press-announcements/fda-approves-first-line-immunotherapy-patients-msi-hdmmr-metastatic-colorectal-cancer

Source: Yiyao Guanlan

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