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GSK (NYSE: GSK) said its drug Jemperli (dostarlimab) met the primary objective of progression-free survival (PFS) in patients with intermediate or recurrent endometrial cancer in the third trial.
Endometrial cancer is a type of cancer that starts early stomach.
The trial, called RUBY, is a phase 2 study. Phase 1 is evaluating Jemperli plus standard chemotherapy (carboplatin-paclitaxel) followed by Jemperli versus chemotherapy plus placebo followed by placebo. Part 2 of the study is evaluating Jemperli plus chemotherapy followed by Jemperli plus GSK’s other drug Zejula (niraparib) versus placebo plus chemotherapy followed by placebo.
The study met its primary objective of PFS – the time during/after treatment the patient lived with the disease without progression – in the short-term analysis.
GSK said that the data showed a significant and beneficial effect in the group of patients with microsatellite instability-high (dMMR)/microsatellite instability-high (MSI-H) and in the general population.
A significant clinical benefit in PFS was also seen in the MMRp/microsatellite stable (MSS) group of patients, the company added.
GSK reported that the overall survival (OS) data was imprecise at the time of analysis, but a positive trend was seen in all populations, including the dMMR/MSI-H and MMRp/MSS subgroups.
The most common adverse drug reactions in patients receiving Jemperli in combination with chemotherapy were nausea, alopecia (hair loss), fatigue, peripheral neuropathy, anemia, joint pain, constipation and diarrhea.
GSK said that based on the results of the test, improvements are planned for H1 2023.
The company noted that RUBY is part of an international collaboration between the European Network of Gynecological Oncological Trials and the GOG Foundation.
In October, Jemperli met the primary goal of a phase II trial called PERLA in patients with non-small cell lung cancer.
The drug is approved in the US for the treatment of adults with recurrent or advanced endometrial cancer in the second line.
