Phase 1/2 Data Reveals Positive Effect of Topical LUT014 for Radiation-Induced Dermatitis in Patients With Breast Cancer

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Lutris Pharma has announced today¹ publication of phase 1/2 data in the Journal of the American Academy of Dermatology International,² wherein topical novel B-Raf inhibitor and lead compound LUT014 demonstrated positive effects in radiation-induced dermatitis among patients with breast cancer.

The phase 1/2 trial consisted of an initial open-label part 1 and a double-blind placebo-controlled part 2. In total, the randomized trial enrolled 20 patients with breast cancer and radiation-induced dermatitis. Upon enrollment, patients were randomized to receive topical LUT014 or a placebo for a 28-day treatment period. This treatment period was subsequently followed by a 2-month follow-up period.

As a result, researchers found that 6 of the 8 patients in part 1 who had developed grade 2 radiation dermatitis exhibited complete resolution upon treatment with LUT014. After the 28-day treatment period, 100% of patients who had been assigned to apply topical LUT014 had grade 0 or 1 radiation dermatitis as defined by Common Terminology Criteria for Adverse Events grading.

LUT014 was well-tolerated with no serious adverse events reported, and 7 of 8 patients reported that after treatment, their radiation dermatitis had little to no effect on their overall quality of life.

This success of part 1 prompted a randomized part 2 of the trial. At the conclusion of part 2, all 8 women treated with LUT014 achieved the primary endpoint of a change in severity of radiation dermatitis. These outcomes were determined based on improvements in overall patient quality of life and compared to only 73% of patients in the placebo arm of the trial achieving the same endpoint.

As early as day 7 of the second part of the trial, 75% of patients treated with LUT014 exhibited radiation dermatitis grade improvement, having improved from grade 2 to grade 1, versus 55% of patients assigned to the placebo.

At day 21, 50% of patients assigned to treatment with LUT014 achieved complete recovery versus 27% of patients assigned to the placebo.

"Our data suggest that LUT014 can be safely administered, with no serious adverse events (AEs) observed in either the open-label or randomized parts of the study," said Lutris Pharma Chief Medical Officer Benjamin W. Corn, MD, in the news release.¹

"In part 1 of the trial, by day 28, 6 of 8 (75%) of enrolled patients who developed grade 2 dermatitis at baseline, achieved complete resolution. Additionally, all 8 women in part 2 achieved treatment success, compared to 73% in the placebo arm, illustrating that a positive efficacy signal may be associated with this compound," Corn said.¹ "Importantly, the results support the need for further study of LUT014 in this radiation-induced dermatitis indication, especially since several expert professional bodies such as the Oncologic Nursing Society (ONS), the American Society of Radiation Oncology (ASTRO) and the Multinational Association of Supportive Care in Cancer (MASCC) recently concluded that there is currently no standard treatment for radiation dermatitis."

Lutris Pharma Chief Executive Officer Noa Shelach, PhD, described the publication of data in this journal as a testament to LUT014's potential not only to accelerate patients' recovery from radiation-induced dermatitis, but also to improve their overall quality of life.¹

"Given that the majority of women with breast cancer will develop some form of [radiation dermatitis], and that there remains a clinically meaningful, unmet medical need, with no current, effective treatment options, we believe LUT014 may be able to effectively treat this patient population," Shelach said.¹

References

1. Lutris Pharma announces publication of positive data from its phase 1/2 trial of LUT014 to treat radiation dermatitis in patients with breast cancer. News release. PR Newswire. February 21, 2024. Accessed February 21, 2024. https://www.prnewswire.com/news-releases/lutris-pharma-announces-publication-of-positive-data-from-its-phase-12-trial-of-lut014-to-treat-radiation-dermatitis-in-patients-with-breast-cancer-302066519.html
2. Katz S, Ciuba D, Ribas A, et al. A topical BRAF inhibitor (LUT-014) for treatment of radiodermatitis among women with breast cancer. JAAD Int. Accessed February 21, 2024. https://doi.org/10.1016/j.jdin.2023.11.009