FDA Nod for GSK’s Jemperli in Advanced Endometrial Cancers!

GSKs Jemperli GSK’s new cancer drug Jemperli (dostarlimab) won an FDA approval on Monday, almost two months ahead of its PDUFA date, for use in certain frontline advanced endometrial cancers.

The PD-1, which previously won an accelerated approval in the US as a second-line endometrial cancer drug, is now approved in combo with carboplatin and paclitaxel, followed by Jemperli as a single agent for the treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR), as
determined by an FDA-approved test, or microsatellite instability-high (MSI-H).

There are about 60,000 new cases of endometrial cancer diagnosed every year in the US, according to GSK, and 20-29% of all endometrial cancers are dMMR/MSI-H.

The new approval is based on positive data presented at at the European Society for Medical Oncology annual meeting in March and published in the New England Journal of Medicine that showed the Jemperli combo extended progression-free survival for both the subset and the overall trial population when added to chemotherapy.

Gun­ning for 2023 ap­proval, GSK de­tails PhI­II da­ta for Jem­per­li in front­line en­dome­tri­al can­cer

GSK reported that after 24 months, 36.1% of the 245 patients who took Jemperli plus chemotherapy were still alive and did not see their cancer progress, compared with 18.1% of the 249 patients who received placebo and chemotherapy. Narrowed down to those whose tumors are considered dMMR/MSI-H, and the difference was even larger: PFS rate
for the Jemperli arm (with 53 patients) was 61.4% versus 18.1% for the placebo arm (65 patients). For both groups, the p-value was smaller than 0.0001.

The application for this indication was reviewed by FDA under its Project Orbis collaboration, where it was concurrently submitted to regulators at the European Medicines Agency and in Australia, Canada, Switzerland, Singapore and the UK.

While sales of Jemperli totaled $21 million in 2022, GSK expects the
cancer drug to eventually be a blockbuster and haul in $1 billion to
$2 billion per year at its peak. The FDA’s Oncologic Drugs Advisory
Committee voted 8-5 in February to approve Jemperli in a rare subtype
of locally advanced rectal cancer.

FDA ad­vi­sors vote 8-5 in fa­vor of GSK’s Jem­per­li tri­al plan for rare rec­tal can­cer

Discovered by AnaptysBio, Jemperli was licensed to Tesaro under a collaboration and exclusive license agreement from March 2014.

GSKs Jemperli, GSKs Jemperli