Lutris Pharma, a clinical-stage biopharmaceutical company, has announced that new clinical data from its Phase 2 trial of LUT014 will be presented at the upcoming American Association for Cancer Research (AACR) Annual Meeting 2025. The presentation will feature results from a double-blind, placebo-controlled randomized clinical trial evaluating LUT014 gel for the treatment of acneiform rash caused by epidermal growth factor receptor (EGFR) inhibitor therapy.
The data will be presented by Dr. Anisha B. Patel, Associate Professor in the Department of Dermatology at the University of Texas MD Anderson Cancer Center, during the Clinical Trials Plenary Session titled "New Frontiers in Precision Oncology" on Sunday, April 27, 2025, in Chicago, Illinois.
Novel Approach to Managing EGFR Inhibitor Side Effects
LUT014 represents an innovative approach to addressing one of the most common and troublesome side effects of EGFR inhibitor cancer therapies. The topically-applied B-Raf inhibitor is specifically optimized to harness the paradoxical MAPK activation effect, which may help mitigate the acneiform rash that frequently limits patients' ability to continue their cancer treatment.
EGFR inhibitors are widely used in treating various cancers, including colorectal, lung, head and neck, urinary bladder, pancreatic, and breast cancers. While effective as anti-cancer agents, these therapies frequently cause dermatological toxicities that can significantly impact patient quality of life and treatment adherence.
"The papulopustular skin rash associated with EGFR inhibitors affects the majority of patients receiving these therapies and can lead to dose reductions or even treatment discontinuation," explained Noa Shelach, Ph.D., Chief Executive Officer of Lutris Pharma. "Our goal with LUT014 is to enable patients to maintain their cancer treatment regimens while reducing these debilitating side effects."
The Science Behind LUT014
LUT014 works through a unique mechanism that leverages the paradoxical effect of B-Raf inhibitors. In cancer cells with BRAF mutations, inhibiting the B-Raf protein leads to cell death and tumor shrinkage. However, in normal cells without mutations, blocking this pathway has the opposite effect—it activates the MAPK pathway and stimulates cell growth.
By applying LUT014 topically to the skin, Lutris Pharma aims to enhance cell proliferation and counterbalance the cell destruction that occurs with EGFR inhibitor therapy, potentially reducing the severity of acneiform lesions.
The EGFR signaling pathway plays a crucial role in regulating cell growth, survival, proliferation, and differentiation. B-Raf, a protein encoded by the BRAF gene, functions as a downstream component of this pathway. When EGFR inhibitors block the signals responsible for cell growth as part of cancer treatment, they also affect normal skin cells, resulting in the characteristic rash.
Clinical Trial Design and Significance
The Phase 2 trial being presented at AACR evaluated LUT014 in patients with metastatic colorectal cancer who developed acneiform lesions while receiving EGFR inhibitor therapy. The study's double-blind, placebo-controlled design provides robust evidence regarding the efficacy of this novel approach.
The selection of this data for an oral presentation at the Clinical Trials Plenary Session highlights the significance of addressing treatment-limiting toxicities in cancer care. Improving the management of side effects can potentially enhance treatment adherence and outcomes for cancer patients.
Broader Portfolio and Company Focus
Lutris Pharma's development pipeline focuses on improving anti-cancer therapy effectiveness by addressing cutaneous toxicities that often lead to reduced treatment compliance. Beyond the current application for EGFR inhibitor-induced rash, LUT014 has also shown promise in a Phase 1/2 study for radiation-induced dermatitis in breast cancer patients.
The company's approach represents an important advancement in supportive care for cancer patients, potentially allowing more patients to receive the full benefit of their anti-cancer treatments without interruption or dose reduction due to skin toxicities.
The AACR Annual Meeting 2025 will be held from April 25-30 in Chicago, with Lutris Pharma's presentation scheduled for April 27 at 3:30 pm CT. The abstract number for the presentation is CT018.
