GSK's Anti-PD-1 Monoclonal Antibody Dostarlimab Granted Two New Clinical Trial Approvals in China for Colorectal and Head and Neck Cancers

The official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration recently announced that the dostarlimab injection submitted by GlaxoSmithKline (GSK) has received two new clinical trial implied permissions in China. It is intended for use in adults with locally advanced mismatch repair-deficient (dMMR)/high microsatellite instability (MSI-H).Colon CancerPerioperative treatment of patients; locally advanced unresectedSquamous Cell Carcinoma of the Head and NeckSequential Treatment for Adult Patients After Chemoradiotherapy.

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. In China, this is the product's second approval following its first in July this year.Approved for Clinical UseLater (for rectal cancer), it was again granted a new clinical trial implied permission.

Screenshot source: CDE official website

Dostarlimab (trade 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.The product was first introduced inApril 2021 in the United StatesFDA Accelerated Approval, which has subsequently been approved for multiple tumor indications, coveringdMMR Advanced or RecurrentEndometrial Cancer、dMMR or MSI-H Primary Advanced or RecurrentEndometrial cancer,dMMR recurrent or advanced solid tumors,All primary advanced or recurrent endometrial cancersAdult patients.

Notably, GSK recently announced dostarlimabFirst-line treatment for dMMR/MSI-H locally advanced rectal cancerPhase 2 Clinical TrialLatest Long-term Data. In the study,Patients treated with the experimental drug showed a 100% clinical complete response rate (cCR).GSK described this clinical outcome as "unprecedented" in its press release.

GSK Receives Approval for New Clinical Trials in China, Targeting dMMR/MSI-H Colon Cancer and Unresected Head and Neck Squamous Cell Carcinoma.According to the pipeline information disclosed on GSK's official website, dostarlimab is in Phase 3 clinical trials internationally for these two indications.Among them,AZUR-2A Phase 3 clinical study aimed at comparing the efficacy and safety of dostarlimumab monotherapy versus standard-of-care perioperative treatment in untreated patients with T4N0 or Stage III dMMR/MSI-H resectable colon cancer.Clinical evidence shows that, for a variety ofTumor type, perioperative combination immunotherapy may further improve survival outcomes.

We hope that the subsequent clinical research of this innovative anti-PD-1 monoclonal antibody drug proceeds smoothly, and it can bring new treatment options to more cancer patients as soon as possible.

[1] Official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China. Retrieved Aug 6, 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

[3]GSK Official Website. From https://www.gsk.com/en-gb/innovation/pipeline/