Positive Opinion for Regeneron’s Libtayo

What factors do you think contributed to a positive EMA CHMP opinion for Libtayo (cemiplimab)?
 

The CHMP’s recent positive opinion is based on data from the global phase III EMPOWER-Cervical 1 trial, which showed that Libtayo significantly extended survival compared with standard-of-care therapy in patients with advanced cervical cancer regardless of PD-L1 expression level and histology (1).

The trial’s primary endpoint of overall survival was met, with Libtayo reducing the risk of death by 31 percent in the total population and 27 percent in the squamous cell carcinoma population compared with an investigator’s choice of chemotherapy. Additionally, treatment with Libtayo prolonged progression-free survival by 25 percent percent compared with chemotherapy and a greater percentage of patients treated with Libtayo achieved an objective response than those treated with chemotherapy.

These results demonstrate that Libtayo has the potential to provide new and valuable treatment options to people living with advanced cervical cancer in Europe.

What’s the next step for EU officials on its path to full approval?
 

Libtayo’s availability may vary in each country based on national and regional reimbursement policies.Following the positive CHMP opinion, the European Commission will make a final decision on the marketing authorization application for Libtayo in advanced cervical cancer. We expect that decision in the coming months.

Were there any negative side effects?
 

No new Libtayo safety signals were observed in the phase III trial. Among adverse events (AE) observed in 10 percent or more patients in either group, Grade 3 or higher AEs that occurred more often in the Libtayo group (n=300) than in the chemotherapy group (n=290) include:

• Urinary tract infection (5 percent Libtayo, 3 percent chemotherapy).
• Back pain (1 percent Libtayo, <1 percent chemotherapy).
• Asthenia (2 percent Libtayo, 1 percent chemotherapy).
• Arthralgia (<1 percent Libtayo, 0 percent chemotherapy).
• Pyrexia (<1 percent Libtayo, 0 percent chemotherapy). 

How do you expect Libtayo to benefit cancer patients, particularly women?
 

Despite recent advancements in the prevention and treatment of cervical cancer, there remain limited options for people with recurrent or metastatic cases – especially those who do not express PD-L1. We believe that Libtayo has the potential to make a meaningful difference for patients battling this difficult-to-treat cancer.

Science has the power to change the trajectory of people’s lives – including those with advanced cervical cancer, a disease that has historically had limited treatment options. In recent years, following the availability of the HPV vaccine, there has been a significant decrease in the incidence of cervical cancer, but it remains a leading cause of death in women worldwide (2). The CHMP’s recommendation to approve Libtayo for advanced cervical cancer shows that, although there is still work to do, progress is being made.