OQ011, a topical ointment for hand-foot skin reaction-related pain, yielded positive safety and efficacy in part 1 of 2 phase 2 NOVA-II trial.
Investigators reported that treatment with OQ011 yielded positive patient-reported outcomes in hand-foot skin reaction (HFSR)–related pain associated with VEGFR inhibitor-based therapies, according to findings from part 1 of the phase 2 NOVA-II trial (NCT04088318) .
OQ011 is a topical ointment designed to target locally active VEGF downstream signaling pathways. As such, the treatment may help restore VEGF signaling in cell functionality and viability in VGFR inhibitors, thus improving HFSR symptoms.
“Due to the debilitating side effects of VEGFR 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 [adverse] effects [AEs] that will allow more patients to remain in treatment. We are looking forward to advancing OQL011 to part 2 of the study at a higher dose level,” Michael McCullar, PhD, chief executive officer at OnQuality Pharmaceuticals, said in a press release.
The randomized, double-blind, vehicle-controlled, dose ranging NOVA-II trial, which aimed to improve the quality of life in patients who are receiving anticancer medications, will enroll an estimated 112 patients. In order to be eligible for the study, patients need to receive treatment with a VEGFR inhibitor-based anticancer therapy including monotherapies or combination therapies, and have HFSR severity of grade 2 or higher.
A total of 4 experimental arms will be included in the study. In arms 1 to 3, patients will receive OQ011 at different doses applied topically 3 times a day up to 6 weeks at varying doses. In arm 4, patients will receive the vehicle applied topically 3 times a day up to 6 weeks.
HFSR is often seen as an adverse reaction to tyrosine kinase inhibitors and VEGFR inhibitors. In particular, VEGFR inhibitors hinder vascular repair mechanisms high-impact areas such as the hands and feet. The toxicity is associated with symptoms such as redness, swelling, discomfort, or pain. Approximately half of all patients or more treated with a VEGFR inhibit experience HFSR, with severe cases requiring dose reductions or discontinuation.
The primary end point of the study is the proportion of patients who achieve National Cancer Institute Common Terminology Criteria for Adverse Events for palmar-plantar erythrodysesthesia of grade 0 or 1 within 3 weeks. Secondary end points included those with improved HFSR, those who achieve Common Terminology Criteria for Adverse Events within 6 weeks and change from baseline in HFSR in a quality-of-life questionnaire.
Currently, OnQuality is working with the FDA to improve protocols from part 1 to part 2. Results will be presented at an upcoming conference, and part 2 of the study is set to begin in the first quarter of 2022.
“While the outlook for many types of cancer has improved in recent years, largely due to advancements in anticancer treatments, the new and painful [AE] 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 [HFSR]. 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,” Hong Tang, MD, chief medical officer and co-founder at OnQuality Pharmaceuticals, concluded.
OnQuality Pharmaceuticals reports topline data from phase 2 trial of treatment for cancer therapy included skin toxicity that met expectations. News Release. OnQuality Pharmaceuticals. January 4, 2022. Accessed February 2, 2022. https://prn.to/3rjo84G