FDA Okay of Regeneron’s PD-1 Inhibitor Marks Entry of First Immunotherapy for Advanced Basal Cell Carcinoma

On February 9th, Regeneron and Sanofi announced that Libtayo (cemiplimab), a PD-1 Inhibitor, had received FDA approval for locally advanced basal cell carcinoma (BCC) and accelerated approval in metastatic BCC. Libtayo is now the first immunotherapy approved for BCC patients. Previously in 2018, the drug was FDA approved to treat advanced cutaneous squamous cell carcinoma.

BCC is the most common form of skin cancer, with 2-4 million new cases reported in the US each year. It originates most commonly in areas exposed to the sun. The UV radiation of the sun leads cells within the skin to become cancerous. In the early stages, BCC can be surgically removed. However, in advanced stages, it can destroy skin, tissue, and bone. The lesions caused can lead to disfiguration, and in some cases, it can become life-threatening.

Currently, there only two FDA-approved medications to treat advanced BCC, Vismodegib and Sonidegib. Both of them act by blocking the hedgehog pathway, but many patients do not respond, or cancer becomes resistant to these drugs. New therapies are necessary to combat this cancer.

Libtayo’s Clinical Trial

Libtayo is a human monoclonal antibody invented using Regeneron’s patented VelocImmune technology. Libtayo is a PD-1 inhibitor. Cancers use PD-1 to avoid the body’s immune system. Once PD-1 is blocked, the body can mount an attack against the cancer cells. Libtayo is being co-developed by Regeneron and Sanofi under a global collaboration agreement.

The approval of Libtayo was based on an open-label, multicenter, non-randomized Phase 2 clinical trial. The trial included 132 patients with locally advanced or metastatic BCC. Treatment with Libtayo shrank the BCC in 21% of patients with metastatic BCC and 29% of patients with locally advanced BCC. Libtayo was well tolerated, with the most common adverse reaction being fatigue. Two patients (13%) had to discontinue treatment due to colitis and general physical health deterioration.

“With today’s approval, Libtayo is now approved for both advanced cutaneous squamous cell and basal cell carcinomas, building a strong foundation in dermato-oncology,” said Israel Lowy, M.D., Ph.D., Senior Vice President, Translational and Clinical Sciences, Oncology, at Regeneron.

“Beyond skin cancers, we also continue to investigate the potential of Libtayo in other difficult-to-treat cancers, starting with non-small cell lung cancer where an FDA decision is expected by the end of February.”

Next Steps for Libtayo

Regeneron is currently testing the efficacy of Libtayo in difficult to treat cancers such as cervical, non-small cell lung, and skin cancer. Besides, Libtayo is currently under consideration for approval by the European Medicines Agency for non-small cell lung cancer and BCC following treatment with hedgehog inhibitors.

Last August, Germany’s BioNTech announced its plans to combine BNT111, its mRNA-based, experimental cancer vaccine with Libtayo to evaluate the combo therapy for melanoma treatment. The FDA is also evaluating Libtayo under priority review for advanced non small cell lung cancer.

As per Regeneron’s fourth quarter earnings, Libtayo generated $97 million in sales, of which $74 million came from the US market. This was more than double the earnings recorded in the third quarter of the previous year. With several trials in progress for treating a wide variety of cancers, Libtayo still has the potential to grow further.

Related Article: AstraZeneca, Daiichi Sankyo’s Potential Blockbuster Bags Second US Approval, This Time for Gastric Cancer

References

1. https://newsroom.regeneron.com/news-releases/news-release-details/fda-approves-libtayor-cemiplimab-rwlc-first-immunotherapy
2. https://www.skincancer.org/skin-cancer-information/basal-cell-carcinoma/
3. https://www.mayoclinic.org/diseases-conditions/basal-cell-carcinoma/symptoms-causes/syc-20354187
4. https://investor.regeneron.com/news-releases/news-release-details/positive-pivotal-data-libtayor-cemiplimab-monotherapy-locally
5. https://investor.regeneron.com/static-files/a581c03d-e314-4ce2-8ca9-bc182beaebc9

For more information of Libtayo, please visit here.

Author

Daniel Ojeda