ImCheck Presents Positive Safety and Efficacy Data from the Completed Phase 1 Dose Escalation Cohort of ICT01 plus Pembrolizumab in the EVICTION Trial at ESMO Congress 2022

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  • Broad antitumor immune responses and demonstration of durable disease control from solid tumor patients who previously failed one or more checkpoint-inhibitor regimen, across a range of ICT01 doses in combination with pembrolizumab

  • ICT01 demonstrated a favorable and consistent safety and tolerability profile without dose-limiting toxicities in combination, in line with monotherapy results

ImCheck Therapeutics today presented promising updated safety and patient response data from the completed dose escalation combination cohort of its ongoing EVICTION clinical trial during an oral session at the European Society for Medical Oncology (ESMO) Congress currently being held in Paris, France.  EVICTION is an open-label Phase I/IIa study evaluating ImCheck’s lead antibody ICT01 as a monotherapy in both solid tumor and hematological cancers, and in combination with pembrolizumab in solid tumors.

Results from the Phase I dose-escalation, combination cohorts (n=40 across 6 dose levels) demonstrated that treatment with ICT01 plus pembrolizumab induced disease control in 42% of melanoma (5/12), 22% of non-small-cell lung carcinoma (4/18), 22% of bladder cancer (2/9) patients and in 1 head and neck squamous cell carcinoma (HNSCC) patient, (1/1) as determined by RECIST1.1 criteria. All patients treated had previously failed at least one checkpoint inhibitor (CPI) regimen, which underscores the potential of ICT01 combination therapy as a novel option for relapsed/refractory patients post-CPI treatment, which remains a significant unmet medical need. Two partial responses were achieved in melanoma patients who reached follow-up beyond 6 and 16 months, with the latter patient also achieving a durable complete regression of a brain metastasis from 6 months onward. The broad antitumor response data suggest that higher baseline circulating γ9δ2 T cell levels correlate with better treatment outcomes. This supports the planned patient enrichment strategy utilizing lower baseline γ9δ2 T cell counts, as compared to ICT01 monotherapy, for eligibility in the upcoming Phase IIa combination groups of patients with CPI-refractory melanoma, chemotherapy-resistant bladder cancer, or CPI-refractory HNSCC.

“The data presented today demonstrate that the complementary mechanisms of action for ICT01 and pembrolizumab alter the tumor microenvironment to generate clinical responses against multiple CPI-resistant solid tumors,” commented Paul Frohna, MD, PhD, Chief Medical Officer at ImCheck Therapeutics. “It is encouraging to see a continued good safety profile for ICT01 in the combination setting in addition to robust activation of γ9δ2 T cells that promote tumor infiltration of CD8 and NK cells, which can be fully unleashed to attack the cancerous cells by concomitant PD-1 blockade.”

Pierre d’Epenoux, Chief Executive Officer of ImCheck Therapeutics added: “With these positive data, we further substantiate the potential of ICT01 as a novel, differentiated therapeutic approach for a broad population of cancer patients. We feel confident that we have achieved our goals for the first part of the EVICTION trial, both in monotherapy with cohort expansion already underway and in combination with pembrolizumab. We eagerly anticipate exciting clinical efficacy results from the Phase IIa next year.”

The oral presentation, titled “The Combination of ICT01, a γ9δ2 T cell-activating mAb, plus Pembrolizumab Induces a Broad Antitumor Immune Response and Disease Control in Patients with CPI-Failure Melanoma, NSCLC and Bladder Cancer: EVICTION Trial”, was given by Dr. Stéphane Champiat, lead study investigator of the EVICTION trial at the Gustave Roussy Cancer Center, Paris, France. The data was presented during the investigational immunotherapy session from 14:45 to 16:15 CEST on Saturday September 10, 2022.