LUT014 Gel Demonstrates Statistically Significant Efficacy in Treating Acneiform Rash Associated with EGFR Inhibitor Therapy in Patients with Advanced Colorectal Cancer

Lutris Pharma, a clinical-stage biopharmaceutical company, has announced the presentation of results from a double-blind, placebo-controlled phase 2 randomized clinical trial of its lead compound, LUT014 gel. The study demonstrated statistically significant efficacy of LUT014 in improving acneiform rash in patients treated with cetuximab or panitumumab, both EGFR inhibitors used to treat advanced colorectal cancer. The trial enrolled 118 patients with grade 2 or non-infected grade 3 acneiform rash, who were randomized to receive either LUT014 gel 0.03%, LUT014 gel 0.1%, or a placebo gel. The primary endpoint was the proportion of patients who achieved treatment success, measured by an improvement of at least one grade in CTCAE scoring or an improvement of at least 5 points in the FACT-EGRF-18 HRQoL skin-specific assessment.

Key Takeaways:

• LUT014 gel demonstrated statistically significant rates of success in improving acneiform rash in both cetuximab and panitumumab INT groups compared to placebo, with a success rate of 64.3% in the high dose LUT014 group for panitumumab-treated patients (p=0.028) and 81.8% for cetuximab-treated patients (p=0.021).
• Patients randomized to LUT014 gel had lower rates of interruption of cetuximab or panitumumab therapy due to acneiform rash.
• The high dose of LUT014 showed a statistically significant benefit over placebo in both cetuximab and panitumumab-treated patients, while the low dose of LUT014 showed meaningful efficacy, especially in the open-label extension, where up to 69% of patients in the per-protocol population achieved improvement.
• LUT014 was well-tolerated, with fewer and mostly mild adverse events compared to placebo.
• The study's findings underscore LUT014's potential to be a key therapeutic, offering significant benefits to patients by enabling them to remain on optimal anti-EGFR treatment without interruption.
• The trial's results also highlight the urgent need for an effective solution in the underserved market of EGFR inhibitor-associated cutaneous toxicity, where current approved drugs are limited and there is no established standard of care.

Statistics:

• Success rate in high dose LUT014 (0.1%) for panitumumab-treated patients: 64.3% (p=0.028)
• Success rate in high dose LUT014 (0.1%) for cetuximab-treated patients: 81.8% (p=0.021)
• Success rate in low dose LUT014 (0.03%) for panitumumab-treated patients: 47.6% (p=0.321)
• Success rate in low dose LUT014 (0.03%) for cetuximab-treated patients: 47.4% (p=0.448)
• Rate of interruption of cetuximab or panitumumab therapy due to acneiform rash: significantly lower in LUT014-treated patients compared to placebo

Sources:

• Lutris Pharma. (2025, July 7). Lutris Pharma Announces Presentation of Results from Phase 2 Clinical Trial of LUT014 Gel for the Treatment of Acneiform Rash Associated with EGFR Inhibitor Therapy in Patients with Advanced Colorectal Cancer. PR Newswire.
• Ramchandra, S., et al. (2025). A double-blind placebo-controlled randomized phase 2 clinical trial to assess the efficacy of a topical BRAF inhibitor for acneiform rash toxicities from anti-EGFR therapies. Oral presentation at the European Society for Medical Oncology (ESMO) Gastrointestinal Cancers Congress 2025.