On December 17, 2015 Innate Pharma SA (the "Company" – Euronext Paris: FR0010331421 – IPH) reported the opening of the Phase Ib/II trial of monalizumab (previously IPH2201), a first-in-class NKG2A checkpoint inhibitor, in combination with cetuximab in patients with relapsed or metastatic squamous cell cancer of the head and neck (SCCHN) (Press release, Innate Pharma, DEC 17, 2015, View Source [SID:1234508588]). This multicentric trial, which will include up to 70 patients, will be performed in Europe and the United States. It is the second trial testing monalizumab in head and neck cancer, after the monotherapy neo-adjuvant trial opened in 2014.
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Pierre Dodion, MD, Chief Medical Officer at Innate Pharma, said: "HLA-E is frequently expressed by head and neck cancer cells. Monalizumab is a new checkpoint inhibitor targeting both T and NK cells and preventing their inhibition by HLA-E on tumor cells. Furthermore, monalizumab enhances antibody dependent cellular cytotoxicity (ADCC), one of the mechanisms of action of cetuximab, setting a sound rationale for their combination". He added: "All trials from Innate’s initial clinical development plan are now recruiting patients, involving reference centers. We look forward to continuing on expanding this plan to fully explore the potential of monalizumab".
Dr. Roger Cohen, Associate Director of Clinical Research at the Abramson Cancer Center and Professor of Medicine at the Hospital of the University of Pennsylvania, and lead investigator for the study, said: "Cetuximab is the only targeted therapy approved in recurrent/metastatic head and neck cancer. However, its response rate of about 13% and response duration of less than 6 months leave a significant unmet medical need for this patient population. Immuno-oncology could play a key role in the treatment of head and neck cancer, as demonstrated by a variety of emerging and very promising data. The combination of monalizumab and cetuximab could enhance the efficacy of cetuximab by activating the immune system. This is a very appealing dual mechanism rationale".
This trial is part of a global co-development and commercialization agreement with AstraZeneca for monalizumab. Within this framework, four Phase I/II trials are ongoing: the cetuximab combination trial in SCCHN, two single agent trials respectively in SCCHN and in ovarian cancer*, and a combination trial with ibrutinib in chronic lymphocytic leukemia. The co-development plan also includes a combination clinical trial with monalizumab and durvalumab (MEDI4736), a PD-L1 immune checkpoint inhibitor, in solid tumors, which will be performed by AstraZeneca/MedImmune.