GSK has reported that the double-blind, randomised Phase III FIRST-ENGOT-OV44 trial of Zejula (niraparib) and Jemperli (dostarlimab) combination in treating first-line advanced ovarian cancer met its primary endpoint of progression-free survival (PFS).
Sponsored by the company and led by the French cooperative group focused on gynaecological oncology, GINECO, the international trial has demonstrated a statistically significant improvement in PFS when dostarlimab is added to standard chemotherapy and niraparib maintenance.
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This combination was tested with or without bevacizumab, an angiogenesis inhibitor.
Despite the positive PFS results, the key secondary endpoint of overall survival (OS) did not meet statistical significance.
The tolerability and safety profile observed in the trial were in line with the established safety profiles of the individual therapies involved.
The trial initially divided subjects into three arms, with Arm 1 later closed due to the approval of poly (ADP-ribose) polymerase (PARP) inhibitors in the first-line setting.
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By GlobalDataSubjects were then randomised into Arms 2 and 3, with the primary endpoint being investigator-assessed PFS in these arms. Secondary endpoints include overall survival, PFS, and time to first and second subsequent therapy.
A programmed death receptor-1 (PD-1)-blocking antibody, Jemperli is central to the company’s immuno-oncology research and development efforts.
AnaptysBio discovered Jemperli, which was licensed to TESARO, as part of a partnership and exclusive licence agreement that was signed in March 2014.
GSK now oversees the ongoing development and potential commercialisation of Jemperli and cobolimab, a TIM-3 antagonist.
The European Network for Gynaecological Oncological Trial (ENGOT) groups is part of the European Society of Gynaecological Oncology and comprises 21 trial groups from 31 European countries, dedicated to conducting cooperative clinical trials.
GSK Oncology, R&D global head and senior vice-president Hesham Abdullah said: “As part of our focus in gynaecological cancers, we continue to evaluate the potential of this combination and look forward to sharing full results from the trial.”
In June, the company reported updated outcomes from a Phase II trial of Jemperli for locally advanced mismatch repair deficient (dMMR) rectal cancer.
