274 Complete clearance of actinic keratosis observed from day 8 of tirbanibulin treatment, along with good tolerability: post-hoc analysis of two Phase 3 studies

Tirbanibulin 1% ointment was approved for actinic keratosis (AK) of face or scalp based on two Phase 3 trials. Pooled rates complete (100%) clearance (CC) and partial (≥75%) (PC) in these trials were reported Day (D) 57 treatment, being 49% 72% respectively. We present post-hoc efficacy safety analyses evaluating earlier time points. Participants (N=702) the had 4-8 clinically visible AK lesions (25 cm2 area); 353 randomized to tirbanibulin (self-applied once daily, 5 consecutive days). At study visits (D8-D15-D29-D57) assessed through CC/PC, local skin reactions (LSR) including erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation erosion/ulceration. Each LSR scored between 0-3 (absent-severe). Individual scores added resulting a composite score 0-18. The maximum reached up D57 averaged participants achieving CC at each visit. rate 13.4% D8, increasing during treatment 24.7%(D15), 36.4%(D29) 49.3%(D57). PC 20.2% D8 gradually rose 41.2%(D15), 62.8%(D29) 72.2%(D57). Among patients reaching visit, baseline characteristics similar except trend higher percentage treatments those D8-D15 vs. D29-D57. mean (±standard deviation) follow-up similarly low regardless if obtained D8(4.7±1.8), D15(4.8±2.2), D29(4.9±2.1) D57(4.9±2.1). Although highest with observed D57, this analysis confirms that can show much responses (from D8). These not accompanied by an increase severity LSRs, thus showing good tolerability as compared later responders.