- The Food and Drug Administration on Monday approved Regeneron and Sanofi's immunotherapy Libtayo for the treatment of newly diagnosed advanced lung cancer, expanding the number of patients who can receive the drug.
- Libtayo is now cleared for adults with non-small cell lung cancer whose tumors have particularly high levels of PD-L1, a protein that's correlated with response to immunotherapy. Patients are ineligible if their tumors can be surgically removed, treated with radiation or with drugs that target mutations in genes like ALK or EGFR.
- The companies' drug will compete with immunotherapies from Merck & Co., Bristol Myers Squibb and Roche as a first-line lung cancer treatment, one of the largest markets in oncology. Merck's drug, Keytruda, is considered standard of care, but Sanofi and Regeneron hope to challenge with data from ongoing studies.
Regeneron and Sanofi's third approval for Libtayo — and its second this month — is likely its most significant.
The medicine came to market in 2018 by winning clearance for a type of skin cancer called cutaneous small cell carcinoma. That approval launched Regeneron, best known for the eye drug Eylea, into the oncology space. An OK from the FDA for another skin tumor, basal cell carcinoma, followed two weeks ago.
Libtayo was the first immunotherapy cleared for either condition, part of Regeneron and Sanofi's plan to gain traction in diseases other drugmakers haven't pursued and then expand into more common cancer types. Libtayo is now the "leading immunotherapy for non-melanoma skin cancers," chief scientific officer George Yancopoulos said on an earnings call this month.
By comparison, Keytruda as well as Bristol Myers Squibb's Opdivo and Yervoy first won U.S. approval in melanoma.
But Regeneron and Sanofi have a tough road ahead to prove Libtayo's place versus its more established competitors. The drug earned $271 million in sales in 2020, whereas Keytruda generated $14.4 billion and is one of the world's best-selling medicines.
Monday's approval will for the first time pit Libtayo against Keytruda, Opdivo and Roche's Tecentriq, which are used in lung cancer in different settings and in combination with different drugs.
Though Libtayo is late to arrive on the market, Wall Street analysts still see some room for growth. Last year, SVB Leerink estimated immunotherapy sales in non-small cell lung cancer would hit $20 billion last year and keep growing for the next five years. Cantor Fitzgerald analyst Alethia Young noted last week that even a 15% market share would make for a "blockbuster opportunity" for Libtayo.
"Although Keytruda has significant market share, we don't think that they serve the full market either," Young wrote in a note following the drug's approval.
Regeneron is relying on study results that showed Libtayo helped lung cancer patients live longer than those given chemotherapy. Those results appeared competitive to data that supported Keytruda's approval as monotherapy in patients with confirmed high PD-L1 expression. But they didn't clearly favor Regeneron's drug either, potentially making it more difficult to shift prescribing habits from Keytruda.
Regeneron executives have been tight-lipped about their launch plans, and how they plan to convince doctors used to other options. "We certainly don't want to tip off our competitors," CEO Leonard Schleifer said earlier this month. But "we're working hard on preparing."
In the meantime, the company is also testing combinations of its drug with either chemotherapy or Bristol Myers' Yervoy against Keytruda in a Phase 3 trial. Results from that study are expected this year.
Regeneron and Sanofi, which have unwound parts of a long-standing research partnership, continue to collaborate on Libtayo and split profits on a global basis.