New late-stage trial results for GSK’s Jemperli show improved overall and progression-free survival in a broader range of endometrial cancer patients, which could lead to a potential label expansion.
Tag Archive for: Jemperli
The company announced that a combination of its cancer drugs Zejula and Jemperli, when as used as a maintenance therapy following Jemperli plus chemotherapy, met the main goal of a late-stage trial to treat a certain type of endometrial cancer.
The company stated that its cancer drug Jemperli when combined with chemotherapy, met the primary goal of overall survival in patients with advanced or recurrent endometrial cancer in a late-stage trial.
The FDA has approved Jemperli as an add-on to chemotherapy for patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient or microsatellite instability-high.
Merck’s Keytruda appeared to outperform GSK’s Jemperli in a key endometrial cancer patient subgroup, suggesting late-stage data revealed Monday during the Society of Gynecologic Oncology 2023 Annual Meeting.
It was a good Thursday for GSK’s Jemperli (dostarlimab), as the immunotherapy received both full FDA approval in endometrial cancer and the regulatory go-ahead regarding its development plan in rectal cancer.
The FDA has set a Feb. 9 meeting for its Oncologic Drugs Advisory Committee (ODAC) to discuss whether GSK’s clinical development plans for Jemperli (dostarlimab) could support accelerated approval.
GSK has dropped both GSK3915393, an investigational celiac disease therapeutic, and GSK3878858, a Staphylococcus aureus vaccine hopeful, from its clinical development roster, the company revealed Wednesday.
Targeted business development acquisitions, improvements in R&D and operating performance, and a strengthened post-demerger balance sheet are creating new capacity and flexibility for GSK to invest in growth and innovation for patients and shareholders.
