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Topical Tirbanibulin Under Study for the Treatment of Actinic Keratosis

By: Julia Fiederlein
Posted: Monday, March 15, 2021

Actinic keratosis is a precursor of squamous cell carcinoma. Andrew Blauvelt, MD, of the Oregon Medical Research Center, Portland, and colleagues conducted two identically designed double-blind phase III trials to evaluate the safety and efficacy of the tubulin polymerization and Src kinase signaling inhibitor tirbanibulin as a topical treatment for such lesions. Their results were published in The New England Journal of Medicine.

“Tirbanibulin 1% ointment…was superior to [placebo] for the treatment of actinic keratosis at 2 months but was associated with transient local reactions and recurrence of lesions at 1 year,” the investigators commented. “Trials comparing tirbanibulin with conventional treatments and that have longer follow-up are needed to determine the effects of tirbanibulin therapy on actinic keratosis.”

A total of 702 patients with actinic keratoses on the face or scalp were randomly assigned in a 1:1 ratio to receive topical tirbanibulin or a placebo ointment. For 5 consecutive days, the patients applied the assigned treatment once daily to an area containing four to eight lesions.

In trial 1, the rate of complete clearance was 44% with tirbanibulin and 5% with the placebo (P < .001); the rates in trial 2 were 54% and 13%, respectively (P < .001). According to the investigators, the partial clearance rate seemed to be significantly higher with tirbanibulin than with the placebo. The estimated rate of recurrence at 1 year was 47% among patients with a complete response to tirbanibulin.

The most frequently reported local reactions to tirbanibulin were erythema (91%) and flaking or scaling (82%). Application-site pain and pruritus occurred in 10% and 9% of patients, respectively, and all adverse events were resolved.

Disclosure: For full disclosures of the study authors, visit nejm.org.



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