Regeneron announces CHMP adopts positive opinion for Libtayo

Regeneron (REGN) announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for Libtayo as an adjuvant treatment for adult patients with cutaneous squamous cell carcinoma at high risk of recurrence after surgery and radiation. The European Commission is expected to make a final decision on the application in the coming months. Libtayo was approved by the U.S. Food and Drug Administration for these patients in the U.S. earlier this month. The positive opinion is supported by results from the global Phase 3 C-POST trial investigating adjuvant Libtayo versus placebo in patients with CSCC at high risk of recurrence following surgery and radiation. In the trial, Libtayo reduced the risk of disease recurrence or death by 68% compared to placebo. Fewer patients treated with Libtayo had locoregional or distant recurrence compared with those who received placebo. Detailed data were published in the New England Journal of Medicine in May. The safety profile of Libtayo as adjuvant treatment of patients with CSCC at high risk of recurrence after surgery and radiation is consistent with the known safety profile for Libtayo monotherapy in advanced cancers. In the trial, adverse events occurred in 91% of patients receiving Libtayo and 89% of patients receiving placebo. Grade greater than or equal to3 AEs occurred in 24% and 14% of patients in the Libtayo arm and the placebo arm, respectively. The most common AEs occurring in at least 10% of patients who received Libtayo were fatigue, pruritus, rash, diarrhea, arthralgia, hypothyroidism and maculo-papular rash. The only grade greater than or equal to3 AE that occurred in more than 2% of patients in the Libtayo arm was hypertension. AEs led to permanent discontinuation of treatment in 10% of patients who received Libtayo and 2% of patients who received placebo. Two patients in each arm experienced an AE leading to death.