Tuesday, October 19, 2021

FDA approves GSK’s Jemperli for dMMR endometrial cancer




The US Food and Drug Administration (FDA) has approved GlaxoSmithKline’s (GSK) PD-1 inhibitor Jemperli for the treatment of patients with advanced endometrial cancer with a specific biomarker.

Jemperli (dostarlimab-gxly) has scored a green light in mismatch repair-deficient (dMMR) recurrent or advanced endometrial cancer, as determined by an FDA-approved test.

It is indicated for use in patients who have progressed on or following prior treatment with a platinum-containing regimen.

The approval is backed by results from a cohort of dMMR endometrial cancer patient in the ongoing GARNET trial.

In this trial, results showed an overall response rate (ORR) of 42.3% for patients receiving Jemperli monotherapy treatment, with a complete response rate of 12.7% and partial response rate (PR) of 29.6%.

Of those patients who responded to Jemperli, 93.3% demonstrated a duration of response (DOR) of at least six months, with the median DOR not yet reached after 14.1 months of follow-up.

“Unfortunately, as many as 60,000 women are diagnosed with endometrial cancer in the US each year and these women currently have limited treatment options if their disease progresses on or after first-line therapy,” said Hal Barron, chief scientific officer and president R&D at GSK.

“Today’s approval of dostarlimab by the FDA has the potential to transform the treatment landscape for these women and demonstrates our continued commitment to helping patients with gynaecologic cancers,” he added.

Endometrial cancer has the highest rate of dMMR among tumour types, with this biomarker occurring in approximately 25% of cases. Women with dMMR endometrial cancer may also experience increased rates of recurrence.

In a statement, GSK said that it is also studying Jemperli for endometrial cancer in earlier treatment lines and also in combination with other therapies for patients with advanced solid tumours or metastatic cancer.



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