Currently Enrolling Trials
Jemperli (dostarlimab-gxly) is a programmed death receptor-1 (PD-1)–blocking antibody.
Jemperli is specifically indicated for the treatment of adult patients with mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer (EC), as determined by an FDA-approved test, that has progressed on or following prior treatment with a platinum-containing regimen.
Jemperli is supplied as an injection for intravenous administration. The recommended dosage is:
- Dose 1 through Dose 4: 500 mg every 3 weeks
- Subsequent dosing beginning 3 weeks after Dose 4 (Dose 5 onwards): 1,000 mg every 6 weeks
Administer Jemperli as an intravenous infusion over 30 minutes. Treat patients until disease progression or unacceptable toxicity.
Mechanism of Action
Jemperli (dostarlimab-gxly) is a programmed death receptor-1 (PD-1)–blocking antibody. Binding of the PD-1 ligands, PD-L1 and PD-L2, to the PD-1 receptor found on T cells inhibits T-cell proliferation and cytokine production. Upregulation of PD-1 ligands occurs in some tumors, and signaling through this pathway can contribute to inhibition of active T-cell immune surveillance of tumors. Dostarlimab-gxly is a humanized monoclonal antibody of the IgG4 isotype that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2, releasing PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response.
Adverse effects associated with the use of Jemperli may include, but are not limited to, the following:
Clinical Trial Results
The FDA granted accelerated approval to Jemperli for the treatment of adult patients with mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
The approval is based on results from the dMMR endometrial cancer cohort of the ongoing GARNET trial, a large, multicenter, non-randomized, multiple parallel-cohort, open-label study. Patients received 500 mg of Jemperli as an intravenous infusion once every three weeks for four doses, followed by 1,000 mg once every six weeks until disease progression or unacceptable toxicity. The primary endpoints in the GARNET trial were overall response rate (ORR) and duration of response (DOR) as assessed by blinded independent central review (BICR). Results showed an ORR of 42.3% with a complete response (CR) rate of 12.7% and partial response rate (PR) of 29.6% among the 71 evaluable patients with dMMR advanced or recurrent endometrial cancer who had progressed on or after treatment with a platinum-containing regimen. Of those that responded, 93.3% demonstrated a DOR of 6 months or more. After a median follow-up of 14.1 months, the median duration of response was not reached (2.6-22.4+).