Regeneron Pharmaceuticals and Sanofi have reported positive data from the Phase III trial investigating the PD-1 inhibitor Libtayo for treating cervical cancer.
The open-label, randomised, multi-centre trial investigated the efficacy of Libtayo monotherapy compared with chemotherapy in patients suffering from recurrent or metastatic cervical cancer.
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Libtayo demonstrated an overall survival (OS) benefit in the study, reducing the risk of death by 31% compared to chemotherapy.
As recommended by the Independent Data Monitoring Committee (IDMC), the trial will be stopped, with regulatory submissions planned this year.
Regeneron Oncology, Translational and Clinical Sciences, senior vice-president Israel Lowy said: “This trial, which enrolled patients regardless of their PD-L1 status, demonstrated that Libtayo helped patients with recurrent or metastatic cervical cancer live longer after progression on prior chemotherapy.
“This is the fourth patient population in which Libtayo has shown clinical benefit and we look forward to submitting the results to regulatory authorities later this year.”
Libtayo is being jointly developed by the two companies under a global collaboration agreement.
Currently, the use of Libtayo in cervical cancer is in the investigational stage and is yet to be completely reviewed by a regulator.
Sanofi Oncology and Pediatric Innovation global development head Peter C Adamson said: “Combined with data from our non-melanoma skin cancer and lung cancer studies, these data contribute to the growing evidence demonstrating the significant potential of Libtayo to treat a spectrum of difficult-to-treat cancers.”
Cervical cancer is the fourth leading cause of cancer death in women globally. The treatment options are limited when the disease is detected in advanced stages.
