FDA Expands Indication for GSK's Anti-PD-1 Monoclonal Antibody Dostarlimab to Include All Adult Patients with Primary Advanced or Recurrent Endometrial Cancer
GSK
Pharmaceutical R&D Manufacturer
On August 1, GSK's official website announced that the FDA has approved Dostarlimab in combination with carboplatin and paclitaxel.Subsequently, Dostarlimab was used as a single agent to treat adult patients with primary advanced or recurrent endometrial cancer.
Prior to this, Dostarlimab had been approved for use in combination with chemotherapy to treat mismatch repair deficiency (dMMR) or high microsatellite instability (MSI-H) with primary advanced or recurrent endometrial cancer.
This approval of the indication covers patients with normal mismatch repair function (MMRp) or microsatellite stable (MSS) tumor patients. Such patients account for 70-75% of endometrial cancer patients, and their treatment options are relatively limited.
Dostarlimab is a programmed cell death receptor-1 (PD-1) inhibitor.PD-1) immune checkpoint inhibitor. This drug, combined with chemotherapy, is currently the only immuno-oncology therapy that significantly improves OS in adult patients with primary advanced or recurrent endometrial cancer, regardless of their biomarker status.
The approval of this indication expansion is based on the results of the dual primary endpoints — PFS and OS — from Part 1 of the RUBY Phase III clinical trial. Part 1 of the RUBY trial is the only one in this clinical context to demonstrate a statistically significant OS benefit in all patients with primary advanced or recurrent endometrial cancer. The data showed that, compared with chemotherapy alone, the risk of death in the combination chemotherapy group was reduced by 31%.HR：0.69；95% CI：0.54–0.89）。
At the 2.5-year follow-up time point, the survival rate of patients in the combination chemotherapy group was 61% (95% CI：54-67), while the single chemotherapy group was 49% (95% CI：43-55). In addition, the median OS in the Dostarlimab plus chemotherapy group was extended by 16.4 months compared to the chemotherapy-alone group. Safety and tolerability analysis showed that the safety profile of Dostarlimab combined with carboplatin and paclitaxel was consistent with the known safety profiles of each individual drug.
Except for endometrial cancer, DostarlimabThe currently approved indications also include endometrial cancer, colorectal cancer, and mismatch repair deficiency (dMMR) Recurrent or advanced solid tumors.According to GSK's previously released financial report, during Q2, the drug showed strong growth.Sales reached £108 million。
Currently, the phase III clinical trial of Dostarlimab for the first-line treatment of squamous cell carcinoma of the head and neck is being conducted in China.
