Innate Pharma SA’s test of monalizumab, an anti-NKG2A antibody partnered with AstraZeneca, as a single agent in patients with advanced gynecologic malignancies.
Innate on Wednesday announced preliminary safety results from the dose-ranging part of a Phase I/II trial, which showed that monalizumab was well tolerated by 18 patients with advanced, heavily pretreated ovarian cancer. The patients randomly received three dose levels of monalizumab; 1, 4 and 10mg/kg, every two weeks – six patients at each dose level, and no major differences in terms of safety were observed across the different dose levels.
The most common adverse events (AEs) reported include fatigue and headaches. AEs were mostly low grade and rarely resulted in treatment delays. Preliminary efficacy data showed short-term disease stabilization in 41% of patients, including one patient with a mixed response.
Lesley Seymour, MD, PhD, Professor in Oncology at Queen`s University in Kingston, Ontario and Director of the Investigational New Drug Program at CCTG, said: “Monalizumab was well tolerated in this patient population with advanced gynecologic malignancies. These refractory tumors are an area of unmet need, and are typically treated with cytotoxic chemotherapy which is often poorly tolerated. Building on these initial results, further investigation of monalizumab in these patients is warranted and we are therefore continuing to enroll patients with relapsed and refractory gynecologic malignancies into the expansion phase of the study.”
Pierre Dodion, Chief Medical Officer of Innate Pharma, said: “These are the first clinical data reported with monalizumab in cancer patients and they suggest a favorable safety profile. Preliminary results support the continuation of the ongoing cohort expansion part of this study and we look forward to its results. A comprehensive exploratory clinical plan investigating monalizumab in several indications, as both a monotherapy and combination treatment, is underway. We look forward to reporting further data as we move into 2017.”