- Preliminary results from the multicenter, nonrandomized GARNET phase I study reported this month in JAMA Oncology*, show promise of a novel anti PD-1 therapy for the more effective treatment of patients with recurrent or advanced mismatch repair-deficient endometrial cancer; representing 30% of patients suffering from this tumor type.
- The study investigators, led by Ana Oaknin, Principal Investigator of VHIO’s Gynecological Malignancies Group, sought to improve clinical outcomes for this patient population who have a poor prognosis, and for whom there is no effective standard of care once their disease progresses on treatment with chemotherapy.
Barcelona, October 13, 2020.- Preliminary results of the GARNET study, a phase I clinical trial enrolling 104 patients with recurrent or advanced mismatch repair-deficient endometrial cancer, have shown that the administration of the novel anti-PD-1 monoclonal antibody –dostarlimab (TSR-042)- as monotherapy achieves significant disease control with an objective response rate of 42%.
The GARNET results show promise in responding to an unmet clinical need; to improve outcomes for this sub-population of patients whose overall survival is approximately 12 months. Once these patients progress on prior first-line treatment with platinum-based chemotherapy, there are currently few other options available.
Up until now, that is.
This present multicenter study, which enrolled 104 patients, not only evidenced clinically meaningful and durable antitumor activity, but also showed an acceptable safety profile.
Commenting for VHIO’s Global Communications, lead author Ana Oaknin noted, “Preliminary results from our study open up a much needed, new therapeutic avenue for these patients with a poor prognosis, who currently have few other treatment options available. Our findings point to the potential of immune-based therapy dostarlimab for the more effective treatment of patients suffering from this challenging disease.”
In Europe there are no approved immune-based treatments for these patients. Considering the GARNET trial results, it is hoped that the European Medicines Agency (EMA) will approve dostarlimab after failure to platinum as first line therapy for this sub-group of patients.
“Moving forward, we will complete the entire cohort of the study, with approximately 140 patients. Larger trials, including the currently enrolling randomized, placebo-controlled RUBY trial of dostarlimab in combination with carboplatin-paclitaxel in primary advanced or recurrent disease, will enable us to more deeply explore the efficacy and safety profile of dostarlimab,” concluded Ana, who also leads Vall d’Hebron University Hospital’s Gynecological Tumors Program (Vall d’Hebron Barcelona Hospital Campus).
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 Oct 1. doi: 10.1001/jamaoncol.2020.4515. Epub ahead of print. PMID: 33001143.