The European Commission has authorized the marketing of Jemperli (dostarlimab), in combination with carboplatin and paclitaxel (chemotherapy), for the treatment of adult patients with newly diagnosed or relapsed advanced endometrial cancer with mismatch repair system deficiency ( dMMR) or with microsatellite instability high (MSI-H), who are candidates for systemic therapy. By authorizing this indication, this drug developed by GSK achieves full approval by the EC.
“Women with this type of endometrial cancer often experience disease progression and poor long-term outcomes with current standard treatment. With this approval we can expand the number of patients who can potentially benefit from this treatment in Europe, including patients who are at an earlier stage of their disease. “We are proud of the recent approvals of dostarlimab, as we believe it is a drug that continues to transform the therapeutic landscape of first-line endometrial cancer and is a promising treatment to become a key immuno-oncology therapy in the treatment of cancer.” , stated Hesham Abdullah, Senior Vice President, Global Head of Oncology R&D at GSK, in a press release released by the company.
Dostarlimab is a monoclonal antibody that blocks the programmed cell death protein 1 (PD-1) receptor and is the first immunotherapy funded for the treatment of endometrial cancer with dMMR/MSI-H. The approval of the European Medicines Agency (EMA) has been based on the results of the ‘Garnet’ trial, which met its primary objective of survival free of disease progression and demonstrated statistically significant and clinically relevant benefits in patients treated with dostarlimab. plus carboplatin and paclitaxel.
A new therapeutic option for advanced endometrial cancer
The results showed in the A1 cohort of women, which included patients with dMMR/MSI-H endometrial cancer (n=143 patients evaluable for efficacy), that treatment with dostarlimab achieved an objective response rate of 45.5% and a disease control rate of 60.1%. The median duration of response had not been reached (1.18+ to +47.21 months) in these patients and the probability of maintaining the response at two years was 83.7%.
“Women with advanced or relapsed endometrial cancer with a dMMR/MSI-H molecular profile will have access to an innovative and effective new therapy”
“From now on, women with advanced or relapsed endometrial cancer with a dMMR/MSI-H molecular profile will have access to a new innovative and effective therapy, which was much needed to improve their prognosis and quality of life.” “said Ana Oaknin Benzaquen, head of the VHIO Gynecological Tumors Unit belonging to the Vall d’Hebron University Hospital in Barcelona and principal investigator of the Garnet study, in statements to Diario Médico. The specialist adds that this trial “demonstrates how treatment with dostarlimab provides clinically significant and durable responses for our patients who previously had few therapeutic options.”
“For GSK it is very satisfactory to be able to provide an innovative therapeutic solution for women with endometrial cancer in our country who, until now, had limited options,” said Eloy Gómez, vice president of Oncohematology at GSK Spain. “To this day, we are very proud to have been able to provide this drug, in the last 2 years, to more than 180 women with endometrial cancer thanks to various early access programs to medications for the treatment of patients without alternatives. therapeutic.”
