Sanofi and Regeneron plan to submit their PD-1 inhibitor Libtayo to regulatory authorities this year for the treatment of advanced cervical cancer, after stopping a phase 3 trial early on efficacy in overall survival (OS).
The phase 3 trial had been investigating Libtayo (cemiplimab) in patients previously treated with chemotherapy whose cervical cancer is recurrent or metastatic.
It included women with either cervical squamous cell carcinoma or adenocarcinoma, who were randomised to receive Libtayo monotherapy or an investigator’s choice of commonly used chemotherapy.
In comparison to chemotherapy, Libtayo reduced the risk of death by 31% compared to chemotherapy in the total population.
For women with cervical squamous cell carcinoma, Libtayo also reduced the risk of death by 27% compared to chemotherapy, and for adenocarcinoma the risk of death was reduced by 44%.
As per a protocol-specified interim analysis, the independent data monitoring committee (IDMC) reviewed OS data first among patients with squamous cell carcinoma, then in the total population.
Sanofi and Regeneron said in a statement that, based on the positive OS data, the IDMC has recommended stopping the trial.
“Recurrent or metastatic cervical cancer is notoriously difficult to treat and has no approved standard of care after first-line chemotherapy,” said Israel Lowy, senior vice president, translational and clinical sciences, oncology, at Regeneron.
“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,” he added.
As a latecomer to the immunotherapy class, Libtayo first entered the market in 2018 with an approval in advanced cutaneous squamous cell carcinoma, a form of skin cancer.
Since then, Sanofi and Regeneron have been conducting a broad research programme for Libtayo, across a range of settings, as a monotherapy and in combination with chemotherapy and other novel agents.
In February, Libtayo received US Food and Drug Administration (FDA) approval in first-line, advanced non-small cell lung cancer (NSCLC).
Specifically, Libtayo (cemiplimab-rwlc) was cleared for use in newly-diagnosed, locally-advanced or metastatic NSCLC patients who have high PD-L1 tumour expression and are not candidates for surgery or definitive chemoradiation.
The NSCLC authorisation closely followed another approval for Libtayo in previously treated advanced basal cell carcinoma.