Phase III trial of Libtayo stopped early after positive overall survival results

pharmafile | March 15, 2021 | News story | Sales and Marketing Cancer, Libtayo, Regeneron, Sanofi 

A Phase III trial of Sanofi and Regeneron’s PD-1 inhibitor Libtayo (cemiplimab) will be stopped early after positive results demonstrated an overall survival (OS) benefit in Libtayo monotherapy compared to chemotherapy in patients previously treated with chemotherapy, whose cervical cancer is recurrent or metastatic.

The trial’s early finish is based on a unanimous recommendation by the Independent Data Monitoring Committee (IDMC), and the data obtained will form the basis of regulatory submissions this year.

The study was the largest Phase III randomised clinical trial in advanced cervical cancer, and included women of a median age of 51 years with either squamous cell carcinoma or adenocarcinoma.

Patients were randomised to receive Libtayo monotherapy – 350 mg every three weeks – or an investigator’s choice of commonly used chemotherapy – pemetrexed, vinorelbine, topotecan, irinotecan, or gemcitabine.

Compared to chemotherapy, the total population of patients receiving the drug experienced a 31% reduced risk of death, with a median 12 months survival for Libtayo compared with 8.5 months for chemotherapy.

The primary endpoint for the trial was OS, analysed first among patients with squamous cell carcinoma, then in the total population. Per a protocol-specified interim analysis, the IDMC reviewed OS data when approximately 85% of events had occurred among patients with squamous cell carcinoma.

Based on the drug’s highly significant effect on OS among the trial participants, the IDMC recommended stopping the trial. Detailed results will be presented at an upcoming medical meeting.

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

Dr Krishnansu S Tewari, Professor and Director of the Division of Gynecologic Oncology at the University of California, Irvine and a trial investigator, said: “Libtayo monotherapy is the first medicine to demonstrate an improvement in overall survival in women with recurrent or metastatic cervical cancer following progression on platinum-based chemotherapy in a Phase III trial.

“This landmark clinical achievement will bring hope to women with advanced cervical cancer who are often younger than patients with other cancers. This is reflected in the trial where the average age was 51.”

Dr Israel Lowy, Senior Vice President of Translational and Clinical Sciences, Oncology at Regeneron, commented: “Recurrent or metastatic cervical cancer is notoriously difficult to treat and has no approved standard of care after first-line chemotherapy.

“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.”

Darcy Jimenez

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