Date: 2015-07-07
Type of information: Publication of results in a medical journal
phase:
Announcement: publication of results in the Journal for ImmunoTherapy of Cancer
Company: ImmunID (France)
Product: ImmunTraCkeR® and ipilimumab
Action
mechanism: companion diagnostic. ImmunTraCkeR® is a proprietary CE-marked immune molecular diagnostics assay. It evaluates a patient’s immune status, from a simple liquid biopsy, based on T lymphocyte repertoire diversity. ImmunTraCkeR® provides information on the patient’s complex immune profile to evaluate clinical benefit or risk under treatment with immunotherapies.
Disease: melanoma
Therapeutic area: Cancer - Oncology - Diagnostic
Country: France
Trial details:
Latest
news: * On July 7, 2015, ImmunID, a French immune molecular diagnostic company, announced the publication of a short report in the * On January 21, 2015, ImmunID announced the enrolment of the first patients in its PREDICT-ID Melanoma study to assess the predictive value of immune profiles for response to ipilimumab. The first two clinical centers, in Lyon and Angers, have recruited five metastatic melanoma patients. These two hospitals will be shortly followed by six additional renowned French centers. * On December 10, 2014, ImmunID announced that the ethic committee and regulatory bodies have granted authorizations to start its PREDICT-ID Melanoma study to assess the predictive value of immune profiles for response to ipilimumab, an immunomodulatory agent approved in more than 40 countries. ImmunID strategic goal is to set the global immune Molecular Diagnostic (iMDx) standard. As part of its strategy, ImmunID is focusing on cancers and particularly on metastatic melanoma. After decades of disappointing results with chemotherapy or targeted therapy, recent clinical successes observed with immunotherapy in melanoma (ipilimumab, an anti-CTLA-4 antibody, nivolumab and pembrolizumab, two anti-PD-1 antibodies, as well as other immune checkpoint inhibitors) confirm the relevance of using the body’s own immune system against the tumor. However, only a small subset of patients achieves benefit from these immunotherapies, which at the same time, can cause serious adverse events. So far no marker predicting response or toxicity has been found for these therapies, which expose a high proportion of patients to unnecessary safety risk, potentially without benefit. Having already successfully showed in a retrospective case study that it is possible to stratify nonresponders to ipilimumab using the ImmunTraCkeR® test (results presented by Dr. Michael Postow from the Memorial Sloan Kettering Cancer Center at the Society for ImmunoTherapy of Cancer Annual Meeting on November 8th, 2014), ImmunID decided to initiate a nationwide French multicenter study for the use of immune competence profiles evaluated by ImmunTraCkeR® as a predictive biomarker of response to Ipilimumab in metastatic melanoma. The PREDICT-ID Melanoma study will start in January 2015 in more than 8 centers and will enroll 200 patients treated with ipilimumab according to the current clinical practices. ImmunTraCkeR® testing will be performed before the start of ipilimumab and regularly during the course of treatment, up to the clinical response assessment. Professor Luc Thomas, a medical oncologist in the Department of Dermatology of the Hospices Civils de Lyon (France), is the principal investigator of the study.
Journal for ImmunoTherapy of Cancer (JITC) showing that the analysis of peripheral T cell receptor diversity using the company’s ImmunTraCkeR® assay is associated with clinical outcomes following ipilimumab treatment in metastatic melanoma. Results from the study, conducted at Memorial Sloan Kettering Cancer Center, were first presented at the Society for ImmunoTherapy of Cancer (SITC) 2014 Annual Meeting. Study results suggest that ImmunTraCkeR® may ultimately be used as a companion diagnostic for
immune checkpoint agents, to determine eligibility to the treatment ("Peripheral T cell receptor diversity is associated with clinical outcomes following ipilimumab treatment in metastatic melanoma"). A larger multicenter study is currently underway (PREDICT-ID Melanoma, France) with the aim to validate prediction capabilities of ImmunTraCkeR® for response to immune checkpoint inhibitors.
