The FDA had accepted the sBLA in September 2021 under priority review status.
Without much explanation, Sanofi and Regeneron reported that they had voluntarily withdrawn their supplemental Biologics License Application from the U.S. Food and Drug Administration for Libtayo (cemiplimab-rwlc), second-line treatment of advanced cervical cancer. They said they “were not able to align on certain post-marketing studies.”
They are still in discussions with regulators outside the U.S. The drug is a fully human monoclonal antibody, a checkpoint inhibitor of the PD-1 checkpoint receptor. The PDUFA date for the sBLA was January 30.
The agency had accepted the sBLA in September 2021 under priority review status. In the third quarter of 2021, Regeneron reported $78 million in Libtayo sales, while Sanofi reported $38.98 million.
The drug is approved for advanced non-small cell lung cancer (NSCLC), advanced basal cell carcinoma (BCC) that has been treated with a hedgehog inhibitor (HHI) or can’t be treated with an HHI and can’t be removed surgically, and advanced cutaneous squamous cell carcinoma (CSCC) that has metastasized or can’t be cured via surgery or radiation.
The FDA accepted the sBLA in September, but the sBLA was also being reviewed under the FDA’s Project Orbit initiative, which allows for regulators in other countries, in this case, Australia, Brazil, Canada and Switzerland, to review the application concurrently. The sBLA was built on data from a Phase III trial that enrolled patients regardless of PD-L1 expression status and is being run with The GOG Foundation, the European Network for Gynaecological Oncological Trial groups (ENGOT) and NRG Oncology-Japan.
The Phase III EMPOWER-Cervical 1 trial is the largest randomized study in advanced cervical cancer. It evaluated Libtayo alone compared to an investigator’s choice of chemotherapy in patients with recurrent or metastatic cervical cancer who had progressed on platinum-based chemotherapy. The study was in people regardless of tumor PD-L1 expression status or histology and was conducted in 14 countries, including the U.S., Japan, Taiwan, South Korea, Canada, Russia, Poland, Spain, Brazil, Australia, the U.K., Italy, Greece and Belgium. The primary endpoint was overall survival, analyzed first in patients with SCC histology and then in the total patient population.
Cervical cancer is the fourth leading cause of cancer deaths in women worldwide. It is most commonly diagnosed between the ages of 35 and 44. The majority are caused by human papillomavirus (HPV) infection, with about 80% being squamous cell carcinoma (SCC), and the rest being mostly adenocarcinomas. About 570,000 people are diagnosed each year with cervical cancer worldwide, with more than 205,000 deaths. There are 14,500 new cases annually and about 4,000 deaths in the U.S. alone.
The most common treatment for advanced cervical cancer is a combination of cisplatin, paclitaxel, and Genentech’s Avastin (bevacizumab). This regimen has an overall response rate (ORR) of 48% with a median survival of 17 months. Still, according to Targeted Oncology, there is no consensus on the benefits of second-line chemotherapy in recurrent cervical cancer.
In October 2021, the FDA approved Merck’s blockbuster checkpoint inhibitor Keytruda (pembrolizumab) combined with chemotherapy, with or without Avastin, for patients with persistent, recurrent, or metastatic cervical cancer with PD-L1 tumor expression. The drug also received regular approval as a monotherapy for recurrent or metastatic cervical cancer with disease progression on or after chemotherapy if the tumors expressed PD-L1.
It’s possible that the competition against Keytruda was a significant factor in their decision to withdraw the sBLA in the U.S. In the third quarter of 2021 alone, Keytruda raked in $4.5 billion in sales.
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