GSK PLC (LSE:GSK, NYSE:GSK) said that the US Food and Drug Administration (FDA) has granted full approval for Jemperli, a drug for the treatment of mismatch repair-deficient endometrial cancer in adult patients.
The approval comes after the successful results from the GARNET phase I trial, which demonstrated an overall response rate of 45.4%.
Jemperli is a programmed death receptor-1 (PD-1) blocking antibody, which works by binding to the PD-1 receptor and blocking its interaction with the PD-L1 and PD-L2 ligands.
The drug received accelerated approval in April 2021 for use in adult patients with recurrent or advanced endometrial cancer, but today's approval confirms its use for full, long-term treatment.
"This US regulatory action confirms our confidence in Jemperli as an important treatment option for patients with dMMR recurrent or advanced endometrial cancer," Hesham Abdullah, GSK's head of oncology said in a statement.
"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 tumours," he added.
Jemperli was administered to 141 patients with advanced or recurrent endometrial cancer as part of the A1 expansion cohort of the GARNET trial.
A total of 85.9% of patients had a duration of response of at least 12 months, with 54.7% of patients experiencing a response lasting 24 months or longer. The treatment was generally well-tolerated, with the most common side effects being fatigue, anaemia, and nausea.
Endometrial cancer is the most common gynecologic cancer globally, with approximately 417,000 new cases reported each year.
GSK said aims to make Jemperli the backbone of its ongoing immuno-oncology research and development programme, both as a standalone treatment and in combination with other cancer therapies.