Sequenta Inc. and the Eastern Cooperative Oncology Group (now part of the ECOG-ACRIN Cancer Research Group) announced an agreement to use Sequenta’s LymphoSIGHT next-generation sequencing method for the measurement of minimal residual disease (MRD) in a prospective clinical trial.
E1411, whose primary goal is to study the effect of bortezomib and lenalidomide in induction and consolidation therapy, will also compare two methods of MRD detection – the LymphoSIGHT platform and flow cytometry – as prognostic markers. Consenting patients will undergo testing for MRD during treatment and for up to three years of clinical follow-up.
The randomized Phase 2 clinical trial, E1411, will recruit 322 patients 60 years of age and older with Mantle cell lymphoma from clinical sites participating with ECOG, which designed and is leading the study. The trial is also available at clinical sites associated with two other cooperative groups, SWOG and the Alliance for Clinical Trials in Oncology.
“Sequenta’s innovative technology will allow us to gain new insight into the prognostic value of MRD testing and to directly test its performance against state-of-the-art flow and imaging techniques,” said Mitchell R. Smith, MD, PhD, of Fox Chase Cancer Center and ECOG study chair for the trial. “Interventions based on subclinical disease progression combined with novel treatment regimens hold the promise of improving outcomes in this difficult disease.”
LymphoSIGHT is a proprietary method for the amplification and sequencing of immunoglobulin and T cell receptors, enabling the ultra-sensitive detection and monitoring of T and B cells (white blood cells). The platform leverages the power of next-generation sequencing to detect individual B cells (in E1411, Mantle cell lymphoma cells) at levels as low as one cell per million white blood cells using a universal reagent set and routinely available blood samples. Previous results using LymphoSIGHT have shown significantly improved sensitivity to detect MRD compared with flow cytometry, with greatly improved workflows over current real-time polymerase chain reaction assays.
“Our participation in a high-profile clinical trial such as this one represents a great opportunity for our technology platform and provides a demonstration of the value Sequenta can deliver as an integrated testing lab,” said Sequenta CEO Tom Willis.
Sequenta announced last week the inclusion of LymphoSIGHT in the SWOG S1106 Mantle cell lymphoma clinical trial to measure MRD.
Date: August 13, 2012
Source: Sequenta Inc.
Filed Under: Drug Discovery
