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GSK receives CHMP positive opinion recommending approval of dostarlimab for women with recurrent or advanced endometrial cancer

For media and investors only

Issued: London, UK

GlaxoSmithKline (GSK) plc today 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. 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.[1] 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.[2]

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.[3] 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[4] 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.

About GARNET

The ongoing phase 1 GARNET trial is evaluating dostarlimab as monotherapy in patients with advanced solid tumours. Part 2B of the study includes five expansion cohorts: dMMR/MSI-H endometrial cancer (cohort A1), mismatch repair proficient/microsatellite stable (MMRp/MSS) endometrial cancer (cohort A2), non-small cell lung cancer (cohort E), dMMR/MSI-H non-endometrial or POLE-mut solid tumour basket cohort (cohort F), and platinum-resistant ovarian cancer without BRCA mutations (cohort G). GARNET is ongoing and enrolling patients.

About endometrial cancer

Endometrial cancer is a main type of uterine cancer that forms in the inner lining of the uterus, known as the endometrium.[5] Endometrial cancer can be classified as dMMR/MSI-H or MMRp/MSS. There are limited treatment options for patients whose disease progresses on or after first-line therapy.

GSK in Oncology

GSK is focused on maximising patient survival through transformational medicines. GSK’s pipeline is focused on immuno-oncology, cell therapy, cancer epigenetics and synthetic lethality. Our goal is to achieve a sustainable flow of new treatments based on a diversified portfolio of investigational medicines utilising modalities such as small molecules, antibodies, antibody drug conjugates and cells, either alone or in combination.

About GSK

GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information please visit www.gsk.com/about-us.

Cautionary statement regarding forward-looking statements

GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D "Risk Factors" in the company's Annual Report on Form 20-F for 2019 and any impacts of the COVID-19 pandemic.

References 

[1] Endometrial cancer. World Cancer Research Fund. https://www.wcrf.org/dietandcancer/endometrial-cancer. Published September 12, 2018. Accessed December 2019.

[2] Endometrial cancer. World Cancer Research Fund. https://www.wcrf.org/dietandcancer/endometrial-cancer. Published September 12, 2018. Accessed December 2019.

[3] Laken H, Kehry M, Mcneeley P, et al. Identification and characterization of TSR-042, a novel anti-human PD-1 therapeutic antibody. European Journal of Cancer. 2016;69,S102. doi:10.1016/s0959-8049(16)32902-1.

[4] A Study of Dostarlimab (TSR-042) Plus Carboplatin-paclitaxel Versus Placebo Plus Carboplatin-paclitaxel in Patients with Recurrent or Primary Advanced Endometrial Cancer (RUBY). https://clinicaltrials.gov/ct2/show/NCT03981796. Accessed May 2020.

[5] Endometrial Cancer Treatment (PDQ®) – Health Professional Version. National Cancer Institute. https://www.cancer.gov/types/uterine/hp/endometrial-treatment-pdq. Accessed January 2020.