The US Food and Drug Administration (FDA) has granted regular approval to Jemperli (dostarlimab-gxly) for the treatment of adults with mismatch repair-deficient (dMMR) recurrent or advanced endometrial cancer, as determined by an FDA-approved test, whose disease has progressed on or after treatment with a platinum-containing regimen in any setting and who are not candidates for curative surgery or radiation.
Jemperli was previously granted accelerated approval for this indication based on response rate and durability of response in the phase 1 GARNET trial (ClinicalTrials.gov: NCT02715284). The conversion to regular approval was based on data from an additional 141 patients with dMMR recurrent or advanced endometrial cancer who had progressed on or after a platinum-containing regimen.
Patients received dostarlimab at 500 mg intravenously (IV) every 3 weeks for 4 doses, followed by 1000 mg IV every 6 weeks until disease progression or unacceptable toxicity. The major efficacy endpoints were overall response rate (ORR) and duration of response (DOR).
The ORR was 45.4%, with 15.6% of patients achieving a complete response and 29.8% having a partial response. The median DOR was not reached. Overall, 85.9% of patients had a response lasting at least 12 months, and 54.7% had a response lasting at least 24 months.
The most common adverse reactions reported were fatigue/asthenia, anemia, rash, nausea, diarrhea, constipation, and vomiting.
“This US regulatory action confirms our confidence in Jemperli as an important treatment option for patients with dMMR recurrent or advanced endometrial cancer,” said Hesham Abdullah, senior vice president and global head of oncology development at GSK. “We continue to unlock the potential of Jemperli as the backbone for our immuno-oncology development programs to address the unmet needs of patients, including earlier lines of endometrial cancer and other solid tumors.”
FDA grants regular approval to dostarlimab-gxly for dMMR endometrial cancer. News release. US Food and Drug Administration. Accessed February 9, 2023. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-regular-approval-dostarlimab-gxly-dmmr-endometrial-cancer.
US FDA grants regular approval for Jemperli for the treatment of patients with recurrent or advanced mismatch repair-deficient endometrial cancer. News release. GSK. Accessed February 10, 2023. https://www.prnewswire.com/news-releases/us-fda-grants-regular-approval-for-jemperli-for-the-treatment-of-patients-with-recurrent-or-advanced-mismatch-repair-deficient-endometrial-cancer-301743848.html.
Jemperli. Package insert. GlaxoSmithKline; 2023. Accessed February 9, 2023. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761174s003s004lbl.pdf.
This article originally appeared on MPR