Topline results from the phase 2 NOVA-II trial showed clinical efficacy and an acceptable safety profile with OQL011.
OQL011, for cancer therapy induced skin toxicity, demonstrated a tolerable safety and acceptable efficacy profile, according to topline results of part 1 of the phase 2 NOVA-II trial reported by OnQuality Pharmaceuticals.
OQL011 is an ointment designed to treat hand-foot skin reaction (HFSR) which is a common adverse event of tyrosine kinase inhibitors, including VEGF inhibitors. HFSR caused by VEGF inhibitors can cause redness, swelling, discomfort or pain, and blistering in the palms of the hands or soles of the feet. Rates of occurrence can exceed 50% depending on the inhibitor used. Severe cases require dose modification or discontinuation, and no FDA-approved therapy exists for HFSR.
"While the outlook for many types of cancer has improved in recent years, largely due to advancements in anticancer treatments, the new and painful side effects of these treatments have not been addressed accordingly. The first part of our phase 2 trial demonstrated the potential of OQL011 in helping patients who are suffering from Hand-Foot Skin Reaction," said Hong Tang, MD, chief medical officer and co-founder of OnQuality Pharmaceuticals, in a press release. "Completing part one of this proof of concept study is a significant milestone, supporting our approach in cancer supportive drug development and bringing us one step closer to fulfilling our mission of bringing innovative new therapies to patients."
The NOVA-II study (NCT04088318) has an estimated enrollment of 112 participants and an estimated completion date of April 2023. The primary end point of the study is the proportion of patients who achieve NCI CTCAE v5.0 - Palmar-Plantar erythrodysesthesia grade 0 or 1. Secondary end points include the proportion of patients who saw improvement in HFSR severity, base change in quality of life, adverse events, and plasma concentration.
During the study, 3 dose levels will be tested. Additionally, 1 cohort will receive a placebo. Treatment will be applied topically 3 times a day for up to 6 weeks.
In order to participate in the study, patients must be at least 18 years of age or older, have a confirmed cancer diagnosis for which a VEGF inhibitor is indicated, have signs of HFSR, be able to use topical medication, and have an ECOG performance status of 2 or less. Patients with an unresolved hand or foot disorder, who are using other topical medication, have on uncontrolled concurrent illness, abnormal lab results, or inadequate renal or liver function are not eligible to participate.
"Due to the debilitating side effects of VEGF inhibitor treatment to combat cancer, up to 30% of patients reduce their therapy dose and up to 17% completely discontinue treatment. We are working to balance the scale in cancer therapy and provide a much-needed solution to side effects that will allow more patients to remain in treatment," said Michael McCullar, PhD, chief executive officer of OnQuality Pharmaceuticals, in a press release. "We are looking forward to advancing QOL011 to part 2 of the study at a higher dose level."
The study is currently recruiting in California, Colorado, Connecticut, Illinois, Kentucky, Maryland, Massachusetts, Missouri, Nebraska, Nevada, New York, Ohio, and Texas.