September 24, 2021

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FDA approved expansion of Dostarlimab indication to all dMMR solid tumors

https://www.fda.gov/

FDA approved expansion of Dostarlimab indication to all dMMR solid tumors

FDA approved expansion of Dostarlimab indication to all dMMR solid tumors.  On August 17, the U.S. Food and Drug Administration (FDA) expanded the indications of dostarlimab-gxly (Jemperli) (a PD-1 blocking antibody) and approved it to be used to treat all patients who progressed during or after treatment.

Recurrent or late mismatch repair defects (dMMR) solid tumors. Dostarlimab is a humanized monoclonal antibody that binds to PD-1 with high affinity, thereby inhibiting programmed death receptor ligands 1 and 2 (PD-L1 and PD-L2).

The FDA approved the drug in April this year for dMMR recurrent or advanced endometrial cancer, and these cancer patients progressed during or after platinum-containing regimens.

The accelerated approval by the FDA is based on the aggregate results of the ongoing GARNET trial’s dMMR endometrial cancer cohort A1 and dMMR solid tumor (non-endometrial cancer) cohort F. The GARNET trial is a multi-center, non-randomized, parallel cohort, open-label study. Cohort F included patients with recurrent dMMR or advanced non-endometrial cancer, with the largest number of patients with colorectal cancer, small bowel cancer, and gastric cancer.

Patients enrolled in cohort A1 need to progress during or after previous treatment with platinum-containing regimens, and patients enrolled in cohort F must make progress after systemic therapy and have not received any satisfactory alternative treatment options. Patients with colorectal cancer have disease progression or intolerance after using fluoropyrimidine, oxaliplatin, and irinotecan.

The new indication for Dostarlimab is based on the results of 209 patients in the GARNET trial. In this trial, the objective response rate for dMMR endometrial and other solid tumors was 41.6%, and the complete response rate was 9.1%. The median duration of response was 34.7 months.

This type of mismatch repair defect has an estimated prevalence of 14% in the United States. This defect is particularly common in endometrial cancer, colorectal cancer, and other gastrointestinal cancers. According to a press release from the manufacturer, GlaxoSmithKline, Dostarlimab has a response duration of 6 months or more for 95% of patients who respond to treatment.

The drug is administered in GARNET as an intravenous infusion of 500 mg every 3 weeks in four divided doses, then 1000 mg every 6 weeks until the disease progresses or unacceptable toxicity occurs.

This year’s 2021 Gastrointestinal Cancers Symposium (2021 Gastrointestinal Cancers Symposium) announced the safety and effectiveness analysis results of GARNET.

Common adverse events include fatigue/weakness (42%), anemia (30%), diarrhea (25%), and nausea (22%). The most common grade 3 or 4 adverse reactions include anemia, fatigue/weakness, elevated transaminases, sepsis, and acute kidney injury. Like other PD-1/PD-L1 inhibitors, serious and fatal immune-mediated adverse reactions may occur in any organ system during or after treatment, including immune-mediated pneumonia, colitis, and hepatitis.

The application of Dostarlimab in the early treatment of endometrial cancer and the use of other drugs in other advanced/metastatic cancers are underway.

(source:internet, reference only)


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