Sanofi’s Libtayo shows positive Phase III results in advanced cervical cancer

pharmafile | May 13, 2021 | News story | |  Libtayo, Sanofi, cemiplimab, cervical cancer 

Regeneron Pharmaceuticals and Sanofi have announced today positive Phase III trial results investigating the PD-1 inhibitor Libtayo (cemiplimab) in patients with recurrent or metastatic cervical cancer who had previously progressed on chemotherapy.

The data were shared as part of a European Society for Medical Oncology Virtual Plenary and adds to previously reported data showing an improvement in overall survival with Libtayo compared with chemotherapy.

In the trial, 78% of patients had advanced cervical cancer that was classified as squamous cell carcinoma. In this patient subgroup, significant improvements were also seen with Libtayo, compared with chemotherapy.

This includes a 27% reduction in the risk of death and a 29% reduction in the risk of disease progression.

This means Libtayo is the first immunotherapy to demonstrate an improvement in overall survival in advanced cervical cancer.

The Phase III trial also found significant differences in patient-reported outcomes favouring Libtayo over chemotherapy.

Additionally, the Phase III trial found Libtayo-treated patients were able to generally improve or maintain their baseline global health status or quality of life over time, while those treated with chemotherapy experienced a deterioration.

Krishnansu S Tewari, Professor and Director of the Division of Gynaecologic Oncology at the University of California, said: “In this Phase III trial, Libtayo demonstrated a significant improvement in overall survival in women with advanced cervical cancer after progression on chemotherapy, reducing the risk of death by 31% compared to chemotherapy in the overall population.

“Improvements in progression-free survival and objective response rate were also demonstrated in the overall population compared to chemotherapy. Taken together, this landmark trial – which enrolled patients regardless of PD-L1 expression status – helps support the use of Libtayo as a potential new second-line treatment for women with advanced cervical cancer who face a poor prognosis and limited treatment options.”

Cervical cancer is the fourth leading cause of cancer death in women worldwide and is most frequently diagnosed in women between the ages of 35 and 44.

It is estimated that approximately 570,000 women are diagnosed with cervical cancer worldwide each year, with deaths exceeding 250,000. Cervical cancer is often curable when detected early and effectively managed, but treatment options are more limited in advanced stages.

The use of Libtayo in advanced cervical cancer is investigational and has not been fully reviewed by any regulatory authority.

Lilly Subbotin

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