ImCheck Presented Updated Positive Data from Phase I/IIa EVICTION-2 Trial of ICT01 in Combination with Low-dose IL-2 at SITC 2023

|   Science & Medicine

Interim data from EVICTION-2 study confirms safety and tolerability profile and broad anti-tumor immune response that is durable across multiple treatment cycles

ImCheck Therapeutics presented today updated data from its ongoing Phase I/IIa EVICTION-2 clinical trial at the Society for Immunotherapy of Cancer 38th annual meeting in San Diego, USA. The poster presentation entitled “ICT01 plus Low Dose SC IL-2 Produces a Robust Anti-Tumor Immune Activation in Advanced Cancer Patients (EVICTION-2 Study)” provided data from the Phase I/IIa study assessing ICT01, a humanized anti-BTN3A monoclonal antibody that selectively activates γ9δ2 T cells, in combination with low-dose IL-2 in patients with advanced solid tumors.

The data show a clear increase in γ9δ2 T cell counts as well as activation and mobilization of CD8 T cells and NK cells, indicating ICT01 in combination with low dose IL-2 can generate a broad immune response. The immune cell expansion and the positive safety and tolerability profile observed support the advance of the study toward the proof of concept stage in part 2,” commented Johann S. de Bono, PhD, Regius Professor of Cancer Research at The Institute of Cancer Research, The University of London,investigator in the EVICTION-2 study, and presenter of the data at SITC 2023.

The effect of ICT01 with low dose IL-2 on anti-tumor immunity suggests the combination regimen holds promise, notably for the treatment of patients with low circulating γ9δ2 T cells and, together with the results from the EVICTION study, underlines the strong immunotherapeutic potential of ICT01 in oncology,” commented Pierre d’Epenoux, Chief Executive Officer of ImCheck Therapeutics.

EVICTION-2 is a two-part, open-label, Phase I/IIa trial assessing the safety, tolerability, pharmacodynamics and anti-tumor effects of ICT01 in combination with low dose IL-2 in advanced-stage solid tumor patients. In the dose escalation Part 1 of the study, patients receive intravenous ICT01 administered on the first day of every 21-day cycle in combination with daily subcutaneous IL-2 on days 1-5 of cycles 1-3. The primary endpoint measured the incidence and severity of treatment-related adverse events and secondary outcomes included γ9δ2 T cell numbers and analysis of the disease control rate in order to select the best regimen(s) for testing in Part 2 of the trial where it will be combined with pembrolizumab. As reported in the poster, 19 patients have completed at least 1 cycle and no dose-limiting toxicities were observed. Reported treatment-related adverse events were mainly mild to moderate and correlated with the profile of ICT01 and IL-2 monotherapy. All cohorts demonstrated an elevation in γ9δ2 T cell counts that peaked at day 8-15. Further immunological observations included the activation, mobilization and proliferation of CD8 T cells and NK cells. Notably, the broad anti-tumor immune response induced by the combination regimen was durable across multiple treatment cycles.

Details of the presentation are:

  • Abstract title: “ICT01 plus Low Dose SC IL-2 Produces a Robust Anti-Tumor Immune Activation in Advanced Cancer Patients (EVICTION-2 Study)”
  • Session title: Clinical Trials in Progress
  • Abstract number: 715
  • Authors: Johann de Bono, Stéphane Champiat, Francois-Xavier Danlos, Martin Wermke, Volker Kunzmann, Aude De Gassart, Emmanuel Valentin, Marina Iché, Maelle Mairesse, Patrick Brune, Katrien Lemmens, Daniel Olive, Paul Frohna
  • Date/Time: Friday November 3rd, 2023, 12:00–1:30 pm and 5:10–6:40 pm PT
  • Location:  Ground Level - Exhibit Halls A and B1 - San Diego Convention Center

The SITC poster is available on ImCheck’s corporate website.