Top line results from a clinical trial treating breast cancer patients with radiation dermatitis (RD) have been positive.
Lutris Pharma, based in Israel, is a biopharma company focused on improving cancer therapies. It announced its results from the open label part 1 and double blinded part 2 of it phase 1/2 trial yesterday (September 7).
It was testing its lead compound, LUT014, a topically applied B-Raf inhibitor – a drug that attacks the B-Raf protein directly. They can shrink or slow the growth of tumors in some people whose melanoma has spread or can’t be removed completely.
Part 1 results showed that, of the eight patients who developed grade 2 RD at baseline, 75% had complete resolution, improving to grade 0 dermatitis with 100% of patients with 1 or 0 as assessed by the Common Terminology Criteria for Adverse Events (CTAE) after 28 days of daily, topically applied LUT014 gel reaching the same result.
The patients all reported in a validated self-reporting questionnaire an improvement in quality of life by day 28 with seven out of eight patients experiencing no or small effect of the dermatitis on their respective quality of life after the treatment course.
Noa Shelach, chief executive officer of Lutris Pharma, said: “We are extremely encouraged by the strong part 1 results and the equally impressive part 2 data, which show 100% of patients with radiation dermatitis in the LUT014 treatment arm experiencing a clinically meaningful treatment effect.
“The secondary endpoints reported were all supportive, as well, and further highlight the potential, unique ability of LUT014 to expedite patient recovery within just one to two weeks and to make a marked difference in quality of life.
“Given the fact that the majority of patients with breast cancer will develop radiation dermatitis, these results further empower our thesis about the promise of LUT014 to treat this patient population.”
The primary endpoint of the open-label part 1 was the incidence of Treatment-Emergent Adverse Events as assessed by CTAE at 12 weeks and the data showed that LUT014 was generally well tolerated, no severe or serious adverse events occurred and no adverse events were associated with discontinuation of the study drug.
The primary endpoint of the double blinded part 2 of the phase 1/2 trial was the change in severity of radiation dermatitis, based on a validated self-reporting.
Of note, all patients treated with LUT014, compared to 73% of patients treated with placebo, achieved the primary endpoint.
Benjamin Corn, chief medical officer of Lutris Pharma, added: “Part 2 of the phase 1/2 study provided us with impactful information that supports the need for further study of LUT014 in this radiation-induced dermatitis indication.
“Based on the top-line results, the 100% success rate indicates that the active arm response is saturated and that there might be an even a greater effect that cannot be detected in the current study design.
“That said, we believe we may be able to see a higher effect between treatment and placebo arms if LUT014 is started earlier, right after a patient’s radiation treatment.”
Secondary endpoints examined further quality of life variables as well as treatment effect. Improvement in the questionnaire score at day seven was noted by an increase of 30% in the treated arm versus placebo arm.
The proportion of patients who showed improvement from grade 2 to grade 1 by day seven was 75% for patients who received LUT014 versus 54% for patients who received placebo; and the proportion of patients who achieved complete recovery to grade 0 by day 28 was 50% for LUT014 versus 36% for placebo.
Antoni Ribas, chairman of the board of directors of Lutris Pharma, said: “These favorable results in patients with radiation dermatitis, coupled with the highly encouraging data generated, thus far, in the company’s study of LUT014 in patients with mCRC with EGFR inhibitor induced acneiform lesions.
“This tells us that the LUT014 compound is active to treat skin conditions that could benefit from the topical administration of this small molecule BRAF inhibitor, which opens the door to its use in numerous additional indications, and we look forward to exploring these options and expanding the pipeline in the future.”