Regeneron's Libtayo is chugging along in skin cancer. Next stop? First-line lung

Regeneron CEO Len Schleifer has called its brand-new cancer drug Libtayo "the engine that could." And Wednesday, those wondering, "could what?" got a glimpse at what the PD-1 latecomer has done so far.

Through the first three months of its launch, Libtayo—which Regeneron shares with Sanofi—racked up $15 million in U.S. sales, Regeneron said, thanks in part to what Leerink Partners analyst Geoffrey Porges called "near-complete patient access" in a note to clients. Some 95% of total lives in commercial, Medicare and Medicaid plans have reimbursement coverage for the cutaneous squamous cell carcinoma therapy, he said.  

What’s more, that $15 million in first-up sales "is demand-driven," commercial chief Marion McCourt said on the company’s fourth-quarter earnings call.

"This is not a product with a lot of inventory building, and what we are seeing is that each month we're showing progress in terms of demand for Libtayo," she said.

Where is the demand coming from? The company is seeing uptake "from some of the most prestigious academic centers," McCourt said, and "secondarily in more community, large hospital settings" with "sophisticated oncology" programs.

"We feel very good about the launch of Libtayo. We're working very hard on it," she added.

Of course, rolling out a product that’s the first approved therapy in its indication is one thing—and Libtayo has that distinction in cutaneous squamous cell carcinoma. But launching in a market dominated by Merck & Co.’s Keytruda, perhaps the industry’s hottest up-and-coming therapy, is quite another. And that’s exactly what Sanofi and Regeneron are planning to do with Libtayo next. The partners have their eyes on the previously untreated lung cancer arena, which Regeneron R&D chief George Yancopoulos called a "major potential indication for Libtayo."

The thing is, while Libtayo was the sixth drug in its class of PD-1/PD-L1 drugs to hit the scene—behind Keytruda, Bristol-Myers Squibb’s Opdivo, Roche’s Tecentriq, AstraZeneca’s Imfinzi and Pfizer and Merck KGaA’s Bavencio—Keytruda is still the only drug that bears a monotherapy nodin first-line lung cancer. So "if our ongoing trials succeed, we have the potential to be the second," Yancopoulos pointed out.

And the Libtayo partners have been doing what they can to ensure they’ve got the data to take on Merck when the time comes: They've doubled the size of their Libtayo-versus-chemo trial in patients with high levels of biomarker PD-L1.

Regeneron is counting on Libtayo to step up as wet age-related macular degeneration competition advances to eye blockbuster Eylea, the drug that first put the company on the map. But it won’t be the only new drug chipping in growth for the New York biotech.

"Despite the potential competitive threat of Novartis’ RTH258 to Eylea that could emerge later this year, we believe the growth from new indications for Eylea, from Dupixent in asthma and adolescent atopic dermatitis (AD) in the U.S. and from launches in new geographies, and from Libtayo in cutaneous squamous cell carcinoma (CSCC), should more than offset the risk of slowing Eylea sales," Leerink’s Porges wrote.

Register as Visitor to CPhI China 2019!