Advanced Cervical Cancer Monotherapy Study Stopped Early for Positive Results
Regeneron Pharmaceuticals, Inc. and Sanofi today announced positive results demonstrating an overall survival benefit from the Phase 3 trial investigating the PD-1 inhibitor Libtayo® (cemiplimab) monotherapy compared to chemotherapy in patients previously treated with chemotherapy whose cervical cancer is recurrent or metastatic.
The trial will be stopped early based on a unanimous recommendation by the Independent Data Monitoring Committee, and the data will form the basis of regulatory submissions in 2021.
This is the largest Phase 3 randomized clinical trial in advanced cervical cancer, and included women (median age: 51 years) with either squamous cell carcinoma or adenocarcinoma. Patients were randomized to receive Libtayo monotherapy (350 mg every 3 weeks) or an investigator's choice of commonly used chemotherapy.
"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 3 trial," said Krishnansu S. Tewari, M.D., Professor and Director of the Division of Gynecologic Oncology at the University of California, Irvine and a trial investigator, in a press statement.
"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 this trial where the average age was 51."
This announcement follows the recent U.S. approval of Libtayo monotherapy for certain patients with advanced non-small-cell lung cancer whose tumors have high PD-L1 expression.
The FDA also recently authorized the use of Libtayo as the first immunotherapy indicated for patients with basal cell carcinoma previously treated with a hedgehog pathway inhibitor (HHI) or for whom an HHI is not appropriate, whose cancer is either locally-advanced (full approval) or metastatic (accelerated approval).
In 2018, Libtayo was approved as the first systemic treatment for certain patients with advanced cutaneous squamous cell carcinoma.
"We are committed to developing therapies for cancers with high unmet needs including patients with advanced cervical cancer," added Peter C. Adamson, M.D., Global Development Head, Oncology and Pediatric Innovation at Sanofi.
"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 worldwide and is most frequently diagnosed in women between the ages of 35 and 44.
Almost all cases are caused by human papillomavirus infection, with approximately 80% classified as squamous cell carcinoma (arising from cells lining the bottom of the cervix) and the remainder largely adenocarcinomas (arising from glandular cells in the upper cervix).
Cervical cancer is often curable when detected early and effectively managed, but treatment options are more limited in advanced stages.
Tarrytown, NY-based Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.
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