Insight

GSK Announced Landmark Results from FIRST Trial in First-Line Advanced Ovarian Cancer

baybiosciences.com

Dec 22, 2024, 16:56

GSK Announced Landmark Results from FIRST Trial in First-Line Advanced Ovarian Cancer

GSK has announced that the FIRST-ENGOT-OV44 phase III trial evaluating the combination of Zejula (niraparib) and Jemperli (dostarlimab) in first-line advanced ovarian cancer has met its primary endpoint of progression-free survival (PFS).

The trial demonstrated a statistically significant improvement in PFS when dostarlimab was added to the standard of care chemotherapy regimen, carboplatin-paclitaxel, alongside niraparib maintenance therapy, with or without bevacizumab.

Hesham Abdullah, Senior Vice President and Global Head of Oncology R&D at GSK, expressed optimism, stating, “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.”

GSK

While the trial’s key secondary endpoint of overall survival (OS) did not reach statistical significance, further analyses are underway. The data will be shared with health authorities and presented at an upcoming scientific meeting.

The safety and tolerability of the combination treatment were consistent with the known profiles of the individual agents, with no new safety concerns reported.

The FIRST-ENGOT-OV44 trial is an international, double-blind, randomized phase III study, led by GINECO, a French cooperative group specializing in gynecological oncology.

The trial investigates the potential of combining dostarlimab with standard platinum-based chemotherapy and niraparib maintenance therapy in patients with stage III or IV nonmucinous epithelial ovarian cancer.

Ovarian cancer remains the eighth most common cancer among women worldwide, with approximately 85% of patients experiencing disease recurrence after initial treatment. These results from the FIRST trial offer hope for improved first-line treatment options, further advancing the fight against ovarian cancer.