FDA Approves Jemperli for Certain Advanced Solid Tumors

The Food and Drug Administration (FDA) granted a new indication for Jemperli (dostarlimab) to include the treatment of adults with mismatch repair-deficient recurrent or advanced solid tumors who have progressed on prior treatments.

The accelerated approval of the programmed cell death receptor-1 (PD-1) blocking antibody was based on durability of response and tumor response rate and can be used for patients who have no suitable alternative treatment options, according to a news release.

“For patients with tumors expressing the (mismatch repair-deficient) biomarker, there continues to be a significant need for new and effective treatments,” said Dr. Hal Barron, chief scientific officer and president of research and development for GlaxoSmithKline, in the release. “I’m excited about GSK’s second oncology FDA approval this year, and the new treatment option it provides for these patients.”

Mismatch repair-deficient tumors account for 14% of patients with solid tumors in the U.S. This biomarker has previously been shown to predict response to immune checkpoint blockade with PD-1 therapy and is most commonly found in colorectal, endometrial and other gastrointestinal cancers.

This FDA approval was based on findings from the GARNET study, which demonstrated an overall response rate of 41.6% in patients with mismatch repair-deficient solid tumors including endometrial and non-endometrial solid tumors. Researchers in this study also found that Jemperli contributed to a complete response rate (disappearance of all cancer from treatment) of 9.1% and a partial response rate (decrease in tumor size or cancer in the body from treatment) of 32.5%. In this study, the median duration of response was 34.7 months, with the majority of patients (95.4%) maintaining a response to the treatment for at least six months. For patients with non-endometrial cancer, the overall response rate (patients with partial or complete response to treatment) was 38.7%.

“(Jemperli) is an important new treatment option for patients with mismatch repair-deficient recurrent or advanced solid cancers who have progressed and have no alternative options,” said Dr. Jubilee Brown, professor and division director of gynecologic oncology at Atrium Health Levine Cancer Institute and investigator in the GARNET study, in the release. “As we saw in the GARNET trial, of those who response to treatment with (Jemperli), nearly all continued to respond for six months or longer.”

Some of the common side effects observed in the GARNET study included anemia, fatigue/weakness, nausea and diarrhea. Of note, the most common severe or worse side effects were fatigue/weakness, increased transaminases (potentially indicating liver inflammation), anemia, acute kidney injury and sepsis. Severe or worse laboratory abnormalities, which occurred in at least 2% of patients in the study, included decreased sodium (when the body holds onto too much water), decreased lymphocytes (which may indicate infection), decreased albumin (indicating conditions in the liver) and increased alkaline phosphatase (potential indicator of liver damage).

Jemperli previously received accelerated approval from the FDA in April this year for the treatment of adults with mismatch repair-deficient recurrent or advanced endometrial cancer who progressed on a platinum-containing regimen.

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