Date: 2015-11-17
Type of information: Interim results
phase:
Announcement: interim results
Company: Integragen (France) Institut Gustave Roussy (France)
Product: sequencing platform
Action mechanism:
Disease:
Therapeutic area: Cancer - Oncology - Diagnostic
Country:
Trial details:
Latest
news: * On November 17, 2015, Gustave Roussy and IntegraGen announced the completion of one thousand analyses over an initial 18 month time period with a clinical research sequencing platform. The sequencing platform, which is operated by IntegraGen at Gustave Roussy and was launched in May 2014, was utilized to identify genetic mutations from DNA and RNA extracted from the tumors of over 400 cancer patients. The molecular profiles of cancer patients were analyzed as part of the MOSCATO (Molecular Screening for Cancer Treatment Optimization) and MAPPYACTS (Molecular Profiling for Pediatric and Young Adult Cancer Treatment Stratification) personalized medicine clinical trials being conducted at Gustave Roussy. The ability to deliver these results in less than three weeks demonstrates the capability of these teams to routinely sequence DNA (exome) and RNA (transcriptome) from tumors for clinical research purposes.
With results of analyses available in less than three weeks, clinicians were able to enroll patients an appropriate personalized medicine clinical trial enabling the patient to receive the most suitable treatment for the genomic profile associated with their tumor within a timeframe compatible with therapeutic decision making. This included many patients benefiting from the ability to enter Phase 1 clinical trials being conducted at Gustave Roussy.
Data from the first 300 analyses performed were presented at the MAP conference recently held in Paris. Results obtained from the sequencing platform were as sensitive (94%) as those typically obtained from conventional methodologies utilized for the analysis of a targeted panel of 75 genes. Additionally, an analysis of the full exome sequencing data from these first cases demonstrated that 38% of the results provided contained clinically relevant information. In addition to the information provided by the targeted analysis, a variety of additional genetic anomalies which were not previously available were identified based on the analysis of the RNA from the patient’s tumors.
The objective of this approach is to optimize the treatment of patients with advanced disease in order to define more targeted and better adapted treatments. The sequencing data obtain from the current and future analyses of patient’s tumors will also generate a significant amount of information that can be processed and subsequently added to a database which catalogues the description of each tumor and provide insight on proliferation mechanisms, dissemination and resistance of each cancer in associated with the molecular findings. This information will ultimately assist in predicting the response to treatments, help patients avoid unnecessary therapies, and identify therapy approaches which are contraindicated based on the patient’s mutational status.
Based on the results obtain to date, Gustave Roussy and IntegraGen have agreed to move to a second stage of their partnership and plan to develop and expanded use of the platform by increasing access of this unit to new types of tests, including projects in the field of immune-oncology and the study of neoantigens.
Gustave Roussy and IntegraGen are also engaged in a separate partnership with INSERM and Sogeti High Tech which is aimed towards improving the availability of bioinformatic information to biologists and oncologists. This initiative, called the ICE (Interpretation of Clinical Exome) project, is focused on developing a scientific software solution that assist with the interpretation of data from the genome sequencing providing a decisionmaking tool for laboratories which analyze sequencing data from cancer patients.
