Regeneron Pharmaceuticals (NASDAQ:REGN) and collaboration partner Sanofi (NASDAQ:SNY) announce positive topline results from a single-arm open-label Phase 2 study evaluating Libtayo (cemiplimab) in patients with the most common type of skin cancer called basal cell carcinoma (BCC) who progressed on or were intolerant of prior hedgehog pathway inhibitor therapy.
The objective response rate (ORR) at week 93 was
29%. 85% of responders experienced an estimated duration of response
(DOR) greater than one year. The disease control rate (DCR) (responders +
stable cancer for at least six months) was 60%.
In patients with metastatic BCC, the ORR was 21% while 83% of responders experiencing a DOC of at least a year. The DCR was 46%.
No new safety signals were observed.
Marketing applications are next up.
The FDA approved the PD-1 inhibitor in September
2018 for cutaneous squamous cell carcinoma (second most common type of
skin cancer).
https://seekingalpha.com/news/3568922-regeneron-and-sanofis-libtayo-shows-benefit-in-skin-cancer
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