History
In 2020, dostarlimab, a PD-1 inhibitor, was undergoing phase I/II and phase III clinical trials.[32][33][34]
In 2020, the manufacturer, Tesaro, announced preliminary successful results from the phase I/II GARNET study.[32][35]
In 2020, the Garnet study announced that dostarlimab had promising potential to treat a specific subset of individuals with recurrent or advanced endometrial cancer.[32]
In April 2021, dostarlimab was approved for the treatment of recurrent or advanced endometrial cancer with mismatch repair deficient (dMMR), which are genetic abnormalities that disrupt DNA repair, in individuals who had previously been treated with platinum-containing regimens.[36]
In April 2021, the US Food and Drug Administration (FDA) granted accelerated approval to dostarlimab-gxly (Jemperli, GSK).[11] Efficacy was evaluated based on cohort (A1) in Garnet Trial (NCT02715284), a multicenter, multicohort, open-label trial in participants with advanced solid tumors.[11] The FDA approved dostarlimab based on evidence from the GARNET trial (NCT02715284) of 71 participants with advanced or recurrent endometrial cancer that was shown to be mismatch repair deficient (dMMR), and for which certain types of chemotherapy did not work or was no longer working. The cohort used for the approved indication was conducted at 40 sites in 7 countries in North America and Europe.[37]
In 2022, an early clinical study of dostarlimab reported a 100% remission rate in 14 patients with rectal cancer who had mismatch repair deficiency, a type of genetic mutation that only affects 5-10% of cases.[38][39][40]
In February 2023, the FDA approved dostarlimab-gxly (Jemperli, GlaxoSmithKline LLC) for adults with mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer, as determined by an FDA-approved test, that has progressed on or following a prior platinum-containing regimen in any setting and are not candidates for curative surgery or radiation.[12]
