Tel Aviv, Israel – October 01, 2026 -- Lutris Pharma reported that its topical B-Raf inhibitor LUT014 achieved Treatment Success in 71.8% of patients with EGFR inhibitor-induced acneiform rash, compared with 38.5% on placebo (p=0.003), in updated Phase 2 data presented at the 35th EADV Congress in Vienna.
LUT014 0.1% gel cuts clinician-assessed rash severity and patient symptom burden
Among the composite endpoint's components, 56.4% of patients on LUT014 0.1% achieved at least a one-grade improvement on the CTCAE v5.0 acneiform rash scale versus 15.4% on placebo (p=0.0002). Using the FACT-EGFRI-18 patient-reported symptom score, 53.8% of treated patients reported at least a five-point improvement versus 28.2% on placebo (p=0.021).
Benefit persists to Day 55, beyond the 28-day treatment window
Treatment Success remained elevated at Day 55, with 69.2% of LUT014 patients maintaining response versus 31.8% on placebo (p=0.005), indicating durability after dosing ended.
Drug adherence to cancer therapy improves sharply with LUT014
Non-adherence to EGFRI anti-cancer therapy occurred in just 10.3% of LUT014-treated patients versus 28.2% on placebo (p=0.044), a result Lutris says supports patients staying on prescribed cancer dosing. The company reiterated that LUT014's safety profile remains favorable, consistent with prior disclosures.
The Phase 2 trial (NCT04759664) enrolled 118 adult colorectal cancer patients who developed CTCAE Grade 2 or non-infected Grade 3 acneiform lesions following cetuximab or panitumumab treatment. Patients received LUT014 0.1% gel (n=39), LUT014 0.03% gel (n=40), or placebo (n=39) once daily for 28 days, followed by a 28-day observation period.
Lutris targets expansion into pancreatic cancer rash indication
Antoni Ribas, Founder and Board Member of Lutris Pharma, said the company plans to initiate a Phase 2 study of LUT014 0.1% gel in daraxonrasib-induced acneiform rash among pancreatic ductal adenocarcinoma patients, citing the drug's mechanistic potential to address rash from other MAPK-pathway inhibitors through partnerships and independent studies.
Anisha Patel, professor of dermatology at The University of Texas MD Anderson Cancer Center, presented the data and noted the durability of benefit extended beyond the treatment period, including activity observed in patients with baseline antibiotic use.
The findings were presented in an oral session titled "Acneiform Rash from EGFR Inhibitor Therapy: Durable, Mechanism-Directed Reduction with Topical LUT014 (B-RAF Inhibitor) in a Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial" on October 2, 2026, at the EADV Congress in Vienna.