- Confirmation of previously reported response rate and new data on durability of response reinforces the potential anti-tumor activity of the monalizumab cetuximab combination
- Clinical program advances with an expansion cohort in patients previously treated with PD-1/L1 therapies
- Management to host KOL call Monday, October 22, 4pm CEST (10am ET)
Innate Pharma SA (the “Company” - Euronext Paris: FR0010331421 – IPH), today announced updated data from the Phase II trial evaluating the safety and efficacy of the combination of monalizumab and cetuximab (anti-EGFR) in previously treated patients with recurrent and/or metastatic squamous cell carcinoma of the head & neck (R/M SCCHN). The data will be discussed today at the ESMO 2018 Congress in Munich, Germany, by Professor Jérôme Fayette, Medical Oncologist at the Centre Léon Bérard Lyon, France. Monalizumab is a first-in-class checkpoint inhibitor targeting NKG2A inhibitory receptors expressed on tumor-infiltrating cytotoxic CD8 T lymphocytes and NK cells.
“These results confirm the emerging clinical activity reported earlier this year at AACR.” commented Pierre Dodion, Chief Medical Officer of Innate Pharma. “This successfully executed study provides the rationale to advance our clinical program and to further investigate the potential benefits of this innovative and differentiated combination in patients who received both prior platinum-based chemotherapy and PD-1/L1 blockers. These patients represent a population with a high unmet medical need.”
As of August 31, 2018, a total of 40 patients with R/M SCCHN were evaluable for safety and efficacy. The highest dose tested for monalizumab in the dose-escalation part of the study (10 mg/kg every 2 weeks) was given in combination with the approved dose and schedule of cetuximab in the Phase II cohort expansion. All patients enrolled had been previously treated with platinum-containing regimens.
In the study evaluating the combination of monalizumab and cetuximab the overall response rate was 27.5% (by RECIST) including 1 confirmed complete response (2.5%) and 10 partial responses (25%). Disease control rate at 24 weeks (DCR) was 35%. Median progression-free survival (PFS) and overall survival (OS) reached 5.0 and 10.3 months, respectively. In addition, there were 3 (18%) responders among the 17 patients who had been previously treated with PD-1/L1 antibodies.
“These data show a response rate and durability of response that are of high interest across the totality of patients. The clinical results are supported by a strong preclinical dataset that demonstrated the synergy between the two components of this non-PD-1/L1 combination therapy,” commented Professor Jérôme Fayette, Investigator of the study. “Currently approved PD-1/L1 therapies have shown overall response rates of 13-16% in patients with head and neck cancer in the second-line setting. Almost half of the patients in the study were previously treated with immunotherapy, and achieving responses in this subpopulation with no treatment option is exciting. In today’s treatment landscape, there is much potential to explore other treatment paradigms that provide alternatives especially to non-responding PD-1/L1 patients.”
Among the 40 patients enrolled in the cohort expansion, the safety findings were consistent with previously presented data at AACR 2017 and 2018, with no additional safety concerns compared to monalizumab or cetuximab given alone. The majority of adverse events (AE) were of Grade 1-2 severity, rapidly reversible and easily manageable. No infusion-related reactions or treatment-related deaths occurred. The most frequent AEs (skin disorders) described with cetuximab were not potentiated by the combination with monalizumab.
The poster is available in the monalizumab section on Innate Pharma’s website.
A KOL call with Dr Cohen, Prof. of Medicine at the Hospital of the University of Pennsylvania, Associate Director of Clinical Research, Abramson Cancer Center Philadelphia and the lead investigator of the study, will be held
Monday, October 22, at 4pm CEST (10am ET)
Dial in numbers:
France and International: +33 (0)1 72 72 74 03 US only: +1 646 722 4916
PIN code: 69616804#
|PR in English||168.34 KB|
|CP en français||326.92 KB|
|ESMO 2018: Phase II study of monalizumab in combination with cetuximab in R/M SCCHN||1.23 MB|
|ESMO 2018: analyst and investor call presentation||698.29 KB|