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Anti-PD-1 therapy for endometrial cancer
Anti-PD-1 therapy for endometrial cancer. In the PD-(L)1 field, GSK will soon debut! Dostarlimab is about to be approved: the first anti-PD-1 therapy for endometrial cancer!
GlaxoSmithKline (GSK) recently announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive review opinion recommending the approval of the anti-PD-1 therapy dostarlimab (formerly known as TSR-042), as A single-agent therapy used to treat patients with mismatch repair defects (dMMR)/microsatellite instability (MSI-H) recurrent or advanced endometrial cancer who have progressed during or after platinum-containing chemotherapy.
Now, CHMP’s opinions will be submitted to the European Commission (EC) for review, which usually makes a final review decision within 2 months. If approved, dostarlimab will be the first anti-PD-1 therapy approved for endometrial cancer in Europe.
Dr. Axel Hoos, Senior Vice President and Head of Oncology Research and Development of GSK, said: “The treatment options for women with relapsed or advanced endometrial cancer are limited, and the prognosis is usually poor. The positive opinions of CHMP bring us closer to endometrial cancer patients in Europe. Offer dostarlimab as a new treatment option to improve the prognosis.”
Endometrial cancer (EC) is a major type of uterine cancer, which forms in the endometrium. EC can be divided into mismatch repair defects/high microsatellite instability (dMMR/MSI-H) or mismatch repair normal/microsatellite stability (MSI-H). For EC patients whose disease progresses during or after first-line treatment, treatment options are limited. EC is the sixth most common female cancer in the world.
The regulatory application of dostarlimab for the treatment of endometrial cancer is based on data from the GARNET study. These data represent the largest data set of anti-PD-1 monotherapy in the treatment of endometrial cancer. The results showed that in patients with recurrent or advanced MMR/MSI-H endometrial cancer who had progressed during or after platinum-containing chemotherapy, dostarlimab treatment provided clinically meaningful results: the overall response rate (ORR) was 42% ( 95%CI: 31-55), disease control rate (DCR) is 58% (95%CI: 45-69).
Endometrial cancer is the sixth most common cancer in women worldwide. Although endometrial cancer can be successfully treated in the early diagnosis, there are still large unmet medical needs in terms of treatment options for women with relapsed or advanced endometrial cancer whose disease progresses after first-line treatment or first-line treatment.
dostarlimab is a humanized anti-PD-1 monoclonal antibody under development that binds to the PD-1 receptor and blocks its interaction with the ligands PD-L1 and PD-L2. Currently, dostarlimab is being reviewed by the US FDA and EU EMA for the treatment of female patients with recurrent or advanced dMMR/MSI-H endometrial cancer who have progressed during or after platinum-containing chemotherapy. In addition, dostarlimab is also being reviewed by the US FDA for the treatment of adult patients with dMMR recurrent or advanced solid tumors.
(source:internet, reference only)