GSK secures full Jemperli FDA approval for endometrial cancer treatment

Biopharma company GSK has secured the full approval of the US Food and Drug Administration (FDA) for its Jemperli (dostarlimab-gxly) drug for recurrent or advanced mismatch repair-deficient endometrial cancer.

Jemperli is indicated for the treatment of adult patients with mismatch repair-deficient (dMMR) recurrent or advanced endometrial cancer that has advanced or after a prior platinum-containing regimen in any setting and are not eligible for curative surgery or radiation.

Jemperli is a programmed death receptor-1 (PD-1)-blocking antibody that attaches to the PD-1 receptor and prevents its interaction with the PD-1 ligands PD-L1 and PD-L2.

Hesham Abdullah – GSK Oncology Development Senior Vice President and Global Head, commenting on the full Jemperli FDA approval said: “This US regulatory action confirms our confidence in Jemperli as an important treatment option for patients with dMMR recurrent or advanced endometrial cancer.

“We continue to unlock the potential of Jemperli as the backbone for our immuno-oncology development programs to address the unmet needs of patients, including earlier lines of endometrial cancer and other solid tumors.”

GSK secures full Jemperli FDA approval for endometrial cancer treatment. Photo courtesy of GSK plc.

The full Jemperli FDA approval was backed by data from the A1 cohort of the ongoing GARNET phase 1 clinical trial, which assessed the efficacy of dostarlimab-gxly in 141 patients with dMMR advanced or recurrent endometrial cancer that has advanced or following prior treatment with a platinum-containing regimen.

In the study, Jemperli showed an overall response rate of 45.4%, with a 15.6% complete response rate and a 29.8% partial response rate.

During the study, patients were administered Jemperli 500mg as an intravenous infusion once every three weeks for four doses. This was followed by 1,000mg once every six weeks until the progression of the disease or unacceptable toxicity.

In April 2021, the US FDA awarded accelerated approval to Jemperli for the treatment of adults with dMMR recurrent or advanced endometrial cancer after prior treatment.

Discovered by AnaptysBio, Jemperli was licensed to Tesaro, under a collaboration and exclusive license deal inked in 2014. In 2019, Tesaro was acquired by GSK and is responsible for the ongoing research, development, marketing, and manufacturing of the cancer drug.