Call it Libtayo’s month. After last week posting key data that could help it enter the lucrative non-small cell lung cancer market, the Sanofi and Regeneron immuno-oncology drug has rung up a win in advanced basal cell carcinoma.
In a phase 2 study of those who had already been treated with one prior therapy, the drug provoked a response in 29% of patients, the partners said Tuesday. And of those responders, about 85% saw the drug’s benefits last for at least a year.
A panel of CATO SMS experts will review the key issues contained in the emerging Agency Guidance and offer thoughts on what changes and options for sponsors may be seen in the coming months.
The market is a wide-open one; there are no approved treatments for those whose disease progresses on—or those who are intolerant to—hedgehog pathway inhibitors, a class that includes Erivedge from Roche’s Genentech. About 20,000 U.S. patients per year develop advanced basal cell carcinoma, Sanofi and Regeneron said.
The companies are plotting regulatory submissions later this year, and if they can score an eventual FDA approval, it’ll reinforce Libtayo’s presence in the skin cancer field, where it already bears a green light—its first and only—in cutaneous squamous cell carcinoma.
But while the drug may be running that niche, it’s hardly alone in the wider skin cancer field. Its nemeses, checkpoint giants Keytruda from Merck and Opdivo from Bristol-Myers Squibb, have transformed the melanoma space since they debuted there several years back, and from there have gone on to rack up go-aheads in a wide array of cancers.
One of those cancers? NSCLC, where Libtayo is hoping to make its debut after last week showing it could top chemo at extending the lives of newly diagnosed patients. But once there, it would have to face Merck’s formidable Keytruda-chemo combo, which has dominated the market on the back of data showing it can slash patients’ risk of death by 51%.
A Product Manager with expertise in pharma marketing and sales operations