Positive Phase 1/2 Results for Lutris Pharma's LUT014 in Treating Breast Cancer Patients' Radiation Dermatitis

Lutris Pharma, a biopharmaceutical firm in the clinical stage, has reported promising results from a phase 1/2 trial of their lead compound, LUT014, which is a novel B-Raf inhibitor applied topically. The study aimed to treat radiation-induced dermatitis (RD) in breast cancer patients and was published in JAAD International. The findings indicate that LUT014 is well-tolerated and may offer significant benefits for grade 2 RD.

The trial was divided into two parts: an open-label phase followed by a double-blind, placebo-controlled phase. In the open-label phase, 75% of the patients saw a complete resolution of their RD by day 28. The second part of the trial involved 20 patients and aimed to gauge the effectiveness of LUT014 against a placebo. The results showed that all eight women treated with LUT014 achieved treatment success, compared to 73% in the placebo group.

LUT014 works by harnessing the paradoxical effect of B-Raf inhibitors, promoting cell growth in normal cells while inhibiting it in cancerous ones. This approach is particularly beneficial for treating RD, which is caused by radiation therapy damaging the skin's cellular structures and immune response.

Currently, there is no FDA-approved treatment specifically for RD, with patients relying on supportive skin care. Lutris Pharma's LUT014 could potentially fill this gap, offering a new treatment option for breast cancer patients suffering from RD.

The study's endpoints included the incidence of treatment-emergent adverse events and changes in RD severity as measured by the Dermatology Life Quality Index (DLQI). LUT014 showed a high tolerability with no severe or serious adverse events reported. The time to recovery was also shorter for the LUT014 group compared to the placebo group.

While the study was not designed to show statistical significance due to its small size, the results are compelling and warrant further investigation. Lutris Pharma is dedicated to improving cancer therapy effectiveness and patient quality of life, particularly for those dealing with skin toxicity from EGFR inhibitors or radiation. Their lead asset, LUT014, is also being trialed for metastatic colorectal cancer patients with EGFR inhibitor-induced acneiform lesions.