FDA Expands Approval of Jemperli Plus Chemo for Some With Endometrial Cancer

The FDA expanded the approval of Jemperli plus chemotherapy in select patients with endometrial cancer.

The Food and Drug Administration has approved Jemperli (dostarlimab-gxly) with chemotherapies carboplatin and paclitaxel followed by single-agent Jemperli for the treatment of adults with primary advanced or recurrent endometrial cancer, the agency announced.

Jemperli was approved with carboplatin and paclitaxel followed by single-agent Jemperli in 2023 as a treatment for primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR) or microsatellite instability-high.

The approval was based on the findings of the phase 3 RUBY trial, which enrolled 494 patients with primary advanced or recurrent endometrial cancer and randomized patients to receive either Jemperli with carboplatin and paclitaxel followed by Jemperli, or placebo plus carboplatin and paclitaxel followed by placebo.

Median overall survival (the time a patient lives, regardless of disease status) was 44.6 months in the Jemperli group and 28.2 months in the placebo group, while the median progression-free survival (the time a patient lives without their disease spreading or worsening) was 11.8 months and 7.9 months, respectively.

The FDA reported that the most common side effects with Jemperli, occurring in at least 20% of patients, were anemia (low red blood cell count), increased creatinine (a sign of poor kidney function), peripheral neuropathy (pain, numbness or tingling in the hands or feet), decreased white blood cell count, fatigue, nausea, alopecia (hair loss), low platelets, increased glucose, lymphopenia (low count of white blood cells called lymphocytes), neutropenia (low levels of white blood cells called neutrophils), liver function test abnormalities, arthralgia (joint stiffness), rash, constipation, diarrhea, decreased albumin (indicative of poor liver or kidney function), abdominal pain, dyspnea (shortness of breath), decreased appetite, increased amylase (indicative of poor pancreas function), urinary tract infection and vomiting. Immune-mediated side effects with Jemperli were similar to those previously reported for the drug.

The recommended dose of Jemperli is 500 milligrams every three weeks for six cycles with carboplatin and paclitaxel, followed by 1,000 milligrams monotherapy every six weeks until disease progression or unacceptable toxicity, or for up to three years, and Jemperli should be administered before chemotherapy when administered on the same day, the agency advised.

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