GSK's Anti-PD-1 Monoclonal Antibody Dostarlimab Receives Chinese IND Approval for dMMR/MSI-H Locally Advanced Rectal Cancer Following 100% Complete Clinical Response in Phase 2 Trial
GSK
Pharmaceutical R&D Manufacturer
Today (July 29), the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) announced,GSK's dostarlimab injection has received clinical trial approval in China, intended for development as a treatment.Locally Advanced, Treatment-Naive Mismatch Repair-Deficient (dMMR)/High Microsatellite Instability (MSI-H) Rectal CancerAdult patients. Public information shows that dostarlimab is an anti-PD-1 antibody, which has previously been approved by the U.S. FDA for multiple anti-tumor indications. This is the first time that the product has been approved for clinical use in China.
Notably, GSK recently announced dostarlimabFirst-line treatment for dMMR/MSI-H locally advanced rectal cancerPhase 2 Clinical TrialLatest Long-term Data. In this study,Patients treated with the investigational drug demonstrated a 100% clinical complete response rate (cCR).GSK described this clinical outcome as "unprecedented" in its press release.
Screenshot source: CDE official website
Dostarlimab (brand name: Jemperli) is a programmed death receptor-1 (PD-1) blocking antibody that binds to the PD-1 receptor and blocks its interaction with the PD-1 ligands PD-L1 and PD-L2. This product has been approved by the FDA for multiple indications, includingdMMR advanced or recurrent endometrial cancer, dMMR or MSI-H primary advanced or recurrent endometrial cancer, dMMR recurrent or advanced solid tumorsIn addition, GSK is continuing to explore the therapeutic potential of the drug in multiple Phase III clinical trials.
The indication for which dostarlimab has been approved for clinical use in China this time is dMMR/MSI-H rectal cancer. GSKJune this yearPublishedAZUR-1 StudyThe updated long-term data, AZUR-1 is a Phase 2 registrational clinical trial designed to explore dostarlimab as a monotherapy alternative to chemotherapy, radiotherapy, and/or surgery for the treatment ofInitial Treatment dMMR/MSI-H Locally Advanced Rectal CancerThe efficacy and safety of patients. According to the press release,Forty-two patients who completed dostarlimab treatment showed a 100% clinical complete response rate (cCR), with the first 24 evaluated patients observing sustained clinical complete response during a median follow-up period of 26.3 months.According to the press release, cCR is defined as complete pathological remission or no tumor as assessed by magnetic resonance imaging, endoscopy, and digital rectal examination.
Andrea Cercek, MD, the principal investigator of the AZUR-1 study, stated in a press release that the clinical results demonstrate the potential of dostarlimab as a new treatment for locally advanced dMMR rectal cancer.This method can lead to durable complete tumor regression.。
Rectal cancer is typically classified as a type of colorectal cancer.Is a cancer that starts in the rectum.Approximately 5-10% of rectal cancers are dMMR/MSI-H, meaning the cancer cells have mutations that affect the correct repair of DNA during cell replication. The current standard treatment for these patients is chemoradiotherapy, and the associated side effects can lead to significant adverse reactions, severely impacting the long-term quality of life for patients.
The approval of GSK's anti-PD-1 monoclonal antibody for clinical trials in China indicates that it will soon be conducting trials in China targetingPatients with Rectal CancerClinical Research.
[1] Website of the Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA) of China. Retrieved Jul 29, 2024, from https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d
[2] Jemperli (dostarlimab-gxly) trial continues to show unprecedented results with no evidence of disease in 100% of patients with locally advanced mismatch repair deficient (dMMR) rectal cancer. Retrieved June 3, 2024 from https://www.businesswire.com/news/home/20240602370374/en
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