GSK Launches Phase 2 Trial in China for Dostarlimab in dMMR/MSI-H Locally Advanced Rectal Cancer Following 100% Clinical Complete Response in Global Study

The official website of China Drug Clinical Trial Registration and Information Disclosure Platform recently announced that GSK (GlaxoSmithKline) has initiated a dostarlimab clinical trial.China Phase 2 Single-ArmClinical research, planned in ChinaUntreated dMMR/MSI-H Locally Advanced Rectal CancerConducted among the subjects.

Public information shows,DostarlimabIt is an anti-PD-1 antibody that was approved for clinical use in China for the first time in July this year.GSK recently announced the productFirst-line treatment for dMMR/MSI-H locally advanced rectal cancerPhase 2 Clinical TrialLatest Long-term Data. In this study,Patients treated with the experimental drug showed a 100% clinical complete response rate (cCR).. The Phase 2 clinical study initiated by the researchers in China targets precisely this indication.

Screenshot source: Official website of the Chinese Clinical Trial Registry and Information Disclosure Platform

DostarlimabIt is a 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.

GSK launched a Phase 2, single-arm, open-label study in China. The main purpose of the trial is to evaluate previously untreatedStage Ⅱ/Ⅲ (Locally Advanced) dMMR/MSI-H Rectal CancerEvaluation in SubjectsDostarlimab MonotherapyThe efficacy, with the primary endpoint assessed by ICR.cCR12 (Continuous Complete Clinical Remission at Month 12)The 12-month period starts from the first disease assessment after the last dose of the study drug (cCR confirmed by ICR). The study will also evaluate secondary endpoints such as cCR24 (sustained complete clinical remission at Month 24), cCR36 (sustained complete clinical remission at Month 36), and EFS3 (3-year event-free survival).

In the study, dostarlimab was administered via a 30-minute intravenous infusion, starting from Cycle 1, with the study drug given at the research center on Day 1 of each 21-day cycle for a total of 9 doses.

GSK has alreadyJune this yearPublishedAZUR-1 StudyThe updated long-term data, AZUR-1 is a Phase 2 registrational clinical trial designed to exploreDostarlimabAs a single agentFirst-line treatmentdMMR/MSI-H Locally Advanced Rectal CancerThe efficacy and safety of patients. According to the press release,Forty-two patients who completed dostarlimab treatment showed 100% cCR, with the first 24 evaluated patients observing sustained clinical complete response during a median follow-up period of 26.3 months.cCR is defined as complete pathological remission or no tumor assessed by magnetic resonance imaging, endoscopy, and digital rectal examination.

This productDostarlimab Initiates Phase 2 Clinical Trial in China, Marking a Significant Progress in the Product's Research in the Country.

[1] Official Website of China Drug Clinical Trial Registration and Information Disclosure Platform. Retrieved Aug 19, 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