GSK's FIRST trial achieves progression-free survival goal in advanced ovarian cancer

LONDON, UK I December 20, 2024 I GSK plc (LSE/NYSE: GSK) has released the main findings from the FIRST-ENGOT-OV44 phase III clinical trial. This study evaluated the efficacy of combining Zejula (niraparib) and Jemperli (dostarlimab) with the standard first-line treatment for advanced ovarian cancer. The investigation showed that adding dostarlimab to the established carboplatin-paclitaxel chemotherapy and niraparib maintenance therapy, with or without bevacizumab, significantly improved progression-free survival (PFS), achieving the trial's primary endpoint.

Hesham Abdullah, Senior Vice President and Global Head of Oncology R&D at GSK, commented on the findings, expressing the company's ongoing commitment to advancing treatments in gynecological cancers. He indicated that while the primary endpoint was met, the secondary endpoint of overall survival did not reach statistical significance. Nevertheless, further analyses are in progress, and the data will be submitted to health authorities and presented at a future scientific event. The combined treatment's safety and tolerability were in line with the expected profiles of the individual drugs.

Ovarian cancer ranks as the eighth most prevalent cancer among women globally. Although initial response rates to platinum-based chemotherapy are high, about 85% of patients experience a recurrence of the disease, which becomes less treatable with each recurrence.

The FIRST trial, a global double-blind, randomized phase III study, was conducted by GSK in collaboration with GINECO, a French group specializing in gynecological oncology. The trial explored the addition of dostarlimab to standard chemotherapy followed by niraparib maintenance, with or without bevacizumab, as a first-line treatment for stage III or IV nonmucinous epithelial ovarian cancer. Initially, participants were divided into three arms: standard chemotherapy with placebo maintenance, standard chemotherapy with niraparib maintenance, and standard chemotherapy combined with dostarlimab followed by maintenance with both niraparib and dostarlimab. Bevacizumab was optional in all groups. Due to new approvals for PARP inhibitors in the first-line setting, the placebo arm was closed, focusing the study on the remaining two groups. The primary goal was to assess PFS in these groups, with secondary goals including overall survival and time to subsequent therapies.

GINECO, established in 1993, is a prominent French organization dedicated to researching ovarian and breast cancers. It is part of international collaborations such as ENGOT and GCIG. ENGOT, founded in 2007, is a network under the European Society of Gynaecological Oncology that conducts cooperative clinical trials across Europe with the aim of improving cancer treatment access and outcomes for women.

Jemperli, integral to GSK's immuno-oncology research, is a PD-1-blocking antibody used in various cancer treatments. In the US, it is approved for use in combination with chemotherapy for certain types of endometrial cancer, as well as for other recurrent or advanced solid tumors under specific conditions.

Zejula, another pivotal drug in the trial, is a PARP inhibitor taken orally for the maintenance treatment of certain advanced ovarian, fallopian tube, or peritoneal cancers in patients responding to platinum-based chemotherapy. It is approved for use based on specific genetic markers.

GSK continues to advance its oncology portfolio, emphasizing immuno-oncology and targeted therapies to improve outcomes for cancer patients worldwide. The company remains focused on leveraging scientific innovation and technology to address unmet medical needs in oncology and other therapeutic areas.