Jemperli Plus Chemo Improves Survival in Advanced, Recurrent Endometrial Cancer

Treatment with the immunotherapy agent, Jemperli (dostarlimab), plus chemotherapy significantly increased survival without disease progression in patients with advanced or recurrent endometrial cancer, according to findings from a recent clinical trial.

Findings from the phase 3 RUBY trial, which were published in The New England Journal of Medicine, also demonstrated that patients with mismatch repair-deficient, microsatellite instability-high disease derived a substantial benefit from treatment with Jemperli plus chemotherapy. Mismatch repair deficiency pertains to cells with many DNA mutations, which may lead to cancer. Microsatellite instability also describes cancer cells with a high number of mutations within microsatellites, which are short sequences of DNA.

READ MORE: MSI-H Status: What You Need to Know

“(Jemperli) showed durable benefit as second-line monotherapy treatment in patients with advanced or recurrent (mismatch repair-deficient, microsatellite instability-high) endometrial cancer who had disease progression during or after platinum therapy,” the researchers wrote in the published study. “The presence of (mismatch repair deficiency) is a well-established biomarker for immune-checkpoint inhibition in several tumor types. Testing for (mismatch repair) and (microsatellite instability) status is important because it is considered both prognostic and predictive for the potential use of immune-checkpoint inhibitor treatments in endometrial cancer.”

In this clinical trial, researchers analyzed data from 494 patients with advanced stage 3 or 4 endometrial cancer or with disease that returned for the first time. Patients were randomly assigned either Jemperli (245 patients) or placebo (249 patients). Both groups of patients also received chemotherapy with carboplatin and paclitaxel.

Patients with mismatch repair-deficient disease accounted for 23.9% of the trial population, which is a similar representation of the real-world population, researchers wrote. According to research published by the American Association for Cancer Research, approximately 20% to 40% of endometrial carcinoma are mismatch repair deficient or microsatellite-instability high.

The main goal of this study was to monitor for progression-free survival (the time from treatment randomization to disease progression or death) and overall survival (the time from treatment randomization to all-cause death). Researchers also assessed the safety of treatment, which included side effects.

The 24-month progression-free survival rates were higher in patients who received Jemperli, according to study data.

In patients with mismatch repair-deficient, microsatellite instability-high disease, the 24-month progression-free survival was 61.4% in patients assigned Jemperli compared with 15.7% in those assigned placebo. Patients in the overall trial population also obtained a progression-free survival benefit at 24 months, with 36.1% in the Jemperli group and 18.1% in the placebo group.

At 24 months, overall survival was observed in 71.3% of patients assigned Jemperli versus 56% of those assigned placebo.

The most common side effects that either occurred or worsened throughout the trial among patients assigned Jemperli or placebo included alopecia (hair loss; 53.5% versus 50%, respectively), nausea (53.9% versus 45.9%) and fatigue (51.9% versus 54.5%).

Side effects considered severe and serious occurred more often in the Jemperli group compared with the placebo group.

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