British pharma company GlaxoSmithKline (GSK) has received US approval for its PD-1 inhibitor Jemperli for the treatment of endometrial cancer.
The Food and Drug Administration (FDA) has approved Jemperli (dostarlimab-gxly) for the treatment of adult patients with mismatch repair-deficient (dMMR) recurrent or advanced endometrial cancer, following an FDA-approved test.
Cells that are mismatch repair (MMR) deficient often have many DNA mutations and are commonly found in colorectal, gastrointestinal and endometrial cancer.
Endometrial cancer has the highest rate of dMMR among solid tumour types, with approximately 25% bearing this biomarker.
The accelerated approval is based on results from the dMMR endometrial cancer cohort of the GARNET trial, evaluating the drug as a monotherapy treatment for these patients.
The primary endpoints in this trial were overall response rate (ORR) and duration of response (DOR), as assessed by blinded independent central review (BICR).
In this trial, among the 71 evaluable patients with advanced or recurrent dMMR endometrial cancer, the ORR was 42.3%, with a complete response rate of 12.7% and partial response (PR) of 29.6%.
For the responding patients, 93.3% demonstrated a DOR of six months or more, with the median duration of response not reached after a median follow-up of 14.1 months.
GSK acquired Jemperli as part of its $5.1bn acquisition of cancer specialist Tesaro, although the drug was initially developed by AnaptysBio.
Following this FDA approval, AnaptysBio has earned a $20m milestone payment. Last year, the company also received milestone payments of $10m and $5m, respectively, for the FDA’s and European Medicines Agency’s (EMA) acceptances of filings for Jemperli.
“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 of R&D at GSK.
“Today’s approval of Jemperli 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.
GSK is also completing ongoing evaluations of Jemperli for patients with advanced dMMR solid tumours, as well as in earlier treatment lines for endometrial cancer.