February 26, 2021: GlaxoSmithKline (GSK) announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending dostarlimab, an anti-programmed death-1 (PD-1) monoclonal antibody, for use as monotherapy in women with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) recurrent or advanced endometrial cancer who have progressed on or following prior treatment with a platinum containing regimen.
The CHMP opinion is one of the final steps in the marketing authorisation procedure prior to approval by the European Commission.
Dr Axel Hoos, Senior Vice President and Head of Oncology R&D, GSK, said: “Treatment options are limited for women with recurrent or advanced endometrial cancer and prognosis is typically poor.
This positive CHMP opinion brings us one step closer to providing dostarlimab as a new treatment option to women with endometrial cancer in Europe with the hope of improving outcomes.
If approved by the European Commission, dostarlimab would be the first anti-PD-1 therapy approved for endometrial cancer in Europe.”
The application is based on data from the GARNET study, which represents the largest dataset of an anti-PD-1 monotherapy treatment in endometrial cancer.
Related News: GSK presents positive efficacy data of dostarlimab at ASCO Gastrointestinal Cancers Symposium
Data from the GARNET study were initially presented at the 2019 Society for the Gynecologic Oncology (SGO) Annual Meeting, and updated data were presented at the 2020 SGO Annual Meeting and the European Society for Medical Oncology (ESMO) Virtual Congress 2020.
Endometrial cancer is the sixth most common cancer in women worldwide.
While endometrial cancer can be treated successfully when diagnosed early, there is a significant unmet need for treatment options for women with recurrent or advanced endometrial cancer whose disease progresses on or after first-line therapy.
Dostarlimab is under review with the US Food and Drug Administration (FDA) for the treatment of women with recurrent or advanced endometrial cancer who have progressed on or following platinum-based chemotherapy and whose tumours are dMMR.
It is also under FDA review for the treatment of adult patients with dMMR recurrent or advanced solid tumours. Dostarlimab is not currently approved for use anywhere in the world.
About dostarlimab
Dostarlimab is a humanised PD-1 monoclonal antibody that binds with high affinity to the PD-1 receptor and blocks its interaction with the ligands PD-L1 and PD-L2.
In addition to GARNET, dostarlimab is being investigated in other registrational enabling studies, including the phase 3 RUBY study for patients with recurrent or primary advanced endometrial cancer in combination with standard of care (SOC) chemotherapy and the phase 3 FIRST study of platinum-based therapy with dostarlimab and niraparib versus SOC platinum-based therapy as first-line treatment of stage III or IV non-mucinous epithelial ovarian cancer.
It is also being evaluated in combination with other therapeutic agents for patients with advanced solid tumours or metastatic cancer.
Dostarlimab was discovered by AnaptysBio and licensed to TESARO, Inc., under a Collaboration and Exclusive License Agreement signed in March 2014. The collaboration has resulted in three monospecific antibody therapies that have progressed into the clinic.
These are: dostarlimab (GSK4057190), a PD-1 antagonist; cobolimab, (GSK4069889), a TIM-3 antagonist; and GSK4074386, a LAG-3 antagonist. GSK is responsible for the ongoing research, development, commercialization, and manufacture of each of these products under the Agreement.”
https://www.gsk.com/en-gb/media/press-releases/gsk-receives-chmp-positive-opinion-recommending-approval-of-dostarlimab-for-women-with-recurrent-or-advanced-endometrial-cancer/
