Jemperli, a cancer drug manufactured by GlaxoSmithKline, improved survival for patients diagnosed with a form of uterine cancer by more than one year, the British drugmaker said Saturday, the latest findings of a late-stage trial by GSK seeking to expand the use of the treatment.
A late-stage trial found the drug also reduced the risk of disease progression.
Patients diagnosed with endometrial cancer showed a more than 16-month improvement in overall survival—the amount of time a patient lives after receiving a diagnosis—when using Jemperli in combination with chemotherapy, GSK said.
The findings—part of a late-stage trial by the drugmaker—also indicated treatment resulted in a 31% and 37% reduction in risk of death and risk of disease progression, respectively, when compared with just chemotherapy treatment, the drugmaker said.
Jemperli is approved by the Food and Drug Administration and the European Union to use with chemotherapy for treating some types of endometrial cancer, which forms in the womb, that are in advanced stages or have returned.
About 43.5% of women in a 108-person study found a reduction in the amount of cancer in the body or the disappearance of all signs of cancer after they used Jemperli.
Another study involving 118 women reported a “statistically significant and clinically meaningful” improvement in progression-free survival, or the amount of time a patient lives after a diagnosis in which their cancer does not worsen.
Common reactions to using Jemperli with chemotherapy include rash, diarrhea, hypothyroidism and hypertension, according to the FDA.
GSK said it would send its trial data to the FDA for regulatory approval.
66,200. That’s the average number of endometrial cancer cases diagnosed in the U.S. each year, according to Johns Hopkins Medicine. That represents about 3.4% of all new cancer cases. The average age of women diagnosed with endometrial cancer is 60, while the cancer is more uncommon under age 45, according to the American Cancer Society.
Dostarlimab—known generically as Jemperli—was developed by GSK in partnership with the biotech firm AnaptysBio in 2014, as the company expanded into cancer drug sales. The drug was approved by the FDA last year for treating advanced or recurrent cancer with carboplatin and paclitaxel, two drugs used for chemotherapy treatments. GSK has continued to research the possible benefits of using Jemperli as part of its “RUBY” trials, including possible treatment for other types of cancer.
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