- Data from the dose-ranging part of a Phase I/II trial of monalizumab in 18 patients with advanced gynecologic malignancies;
- Monalizumab had no dose-limiting toxicities, highest dose level chosen for cohort expansion part;
- Expansion cohort in four indications of gynecologic malignancies is ongoing.
Innate Pharma SA (the “Company” - Euronext Paris: FR0010331421 – IPH) today announces preliminary safety results from the dose-ranging part of a Phase I/II trial investigating monalizumab as a single agent in patients with advanced gynecologic malignancies.
The data are presented today as a poster at the EORTC-NCI-AACR Molecular Targets and Cancer Therapeutics Symposium (Munich, Germany) 10:15 a.m. – 5:00 p.m. CET and will be discussed by Dr Anna Tinker, Medical Oncologist (British Columbia Cancer Agency, Vancouver) on behalf of CCTG during the Spotlight session at 1:10 – 1:20 p.m. CET. Monalizumab is Innate Pharma’s first-in-class anti-NKG2A antibody partnered with AstraZeneca. The trial is sponsored and conducted by the Canadian Cancer Trials Group (CCTG).
In this dose-ranging part of the study, 18 patients with advanced, heavily pretreated ovarian cancer were randomized to receive three dose levels of monalizumab (1, 4 and 10 mg/kg, every two weeks – six patients at each dose level). The data showed that monalizumab was well tolerated in this patient population, with no dose-limiting toxicities observed. 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.”
The cohort expansion part of this trial (up to 98 patients) is ongoing at the recommended Phase II dose (10 mg/kg) in patients with platinum sensitive ovarian cancer, platinum-resistant ovarian cancer, epithelial endometrial cancer and squamous cell carcinoma of the cervix.
- Poster title: “Dose ranging study of monalizumab (IPH2201) in patients with gynecologic malignancies: A trial of the Canadian Cancer Trials Group (CCTG): IND221”
- Presenter: A. Tinker, Canadian Cancer Trials Group
- Location: International Congress Center, Munich, Germany
The poster #296 is available on Innate Pharma’s website.