Novel anti-PD-1 therapy, dostarlimab, approved as a new therapeutic avenue for recurrent or advanced endometrial cancer in Europe

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Supported by the preliminary results* reported from the multi-center, phase I GARNET ongoing study — showing the promise of a novel immune-based therapy, dostarlimab, for the more effective treatment of patients with recurrent or advanced mismatch repair deficient (dMMR/MSI-H) endometrial cancer—this anti-PD-1 novel immunotherapy is the first to have received approval from the European Medicines Agency (EMA) for the treatment of this patient population.

This important development represents new hope for these patients, and a significant  forward step in improving clinical outcomes for these patients with a poor prognosis and formerly few treatment options available once their disease progresses on or following prior treatment with chemotherapy.

Specifically, the GARNET study was designed to respond to an unmet clinical need. Namely, to improve clinical outcomes and achieve durable responses in these patients. Commenting for our Global Communications, Ana Oaknin, Principal Investigator of VHIO’s Gynecological Malignancies Group, and Lead Investigator of the GARNET clinical trial, said: “The approval of this immune-based therapy provides a much-needed, new therapeutic avenue for patients with advanced or recurrent endometrial cancer recurrent or advanced mismatch repair deficient endometrial cancer; representing 30% of patients suffering from this tumor type.”

She continued, “Through our ongoing investigations**, we are evaluating dostarlimab as monotherapy in patients with advanced solid tumors in expansion cohorts. We hope to report similarly promising clinical activity in these additional cohorts of participants with specific types of advanced disease.”





* Oaknin A, Tinker AV, Gilbert L, Samouëlian V, Mathews C, Brown J, Barretina-Ginesta MP, Moreno V, Gravina A, Abdeddaim C, Banerjee S, Guo W, Danaee H, Im E, Sabatier R. Clinical Activity and Safety of the Anti-Programmed Death 1 Monoclonal Antibody Dostarlimab for Patients With Recurrent or Advanced Mismatch Repair-Deficient Endometrial Cancer: A Nonrandomized Phase 1 Clinical Trial. JAMA Oncol. 2020 Nov 1;6(11):1766-1772.

** Study of TSR-042, an Anti-programmed Cell Death-1 Receptor (PD-1) Monoclonal Antibody, in Participants With Advanced Solid Tumors (GARNET).


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