By Julia Karow
This article, originally published June 3, has been updated from a previous version to include comments from Life Technologies CEO Greg Lucier.
A new initiative launched by Life Technologies last week, called the Genomic Cancer Care Alliance, plans to evaluate the utility of whole-genome sequencing for making treatment decisions for patients with a variety of difficult-to-treat cancers in a clinical trial.
Founding partners of the alliance, which is primarily funded by Life Technologies at the moment and will use the company's SOLiD 4 sequencing platform, include the Fox Chase Cancer Center, Scripps Genomic Medicine, and the Translational Genomics Research Institute. US Oncology, which has expertise in managing clinical cancer trials, is expected to be the contract research and site management organization for the trial. Life Tech announced the initiative at the Consumer Genomics conference in Boston last week.
The aim is "to create a mechanism where consumers can access genomic medicine in the course of their cancer care," Life Technologies' chairman and CEO, Greg Lucier, said during a conference presentation. All qualifying members of Life Tech's company health plan, as well as others, will be eligible to enroll.
Late this year, the initiative plans to start enrolling participants with a wide range of cancer types for a pilot study that will most likely focus on patients with advanced cancer who have failed first rounds of therapy.
Lucier said the target is to enroll 100 patients — depending on the available funding — and that the trial has an estimated cost of several million dollars. However, protocols for the study, including the number of patients and cancer types to be included, have yet to be finalized.
TGen, Scripps, and two other currently undisclosed organizations will use the SOLiD 4 system to sequence the genomes of these patients' tumors and matched control tissues in order to identify somatic mutations. These centers will build out their sequencing capacity for the project, Lucier said.
A yet to be announced CLIA-certified lab will validate the results, which will be interpreted by TGen and Omicia, a genome data analysis firm that will develop clinical interpretation algorithms.
Physicians from Fox Chase Cancer Center, TGen, Scripps, and El Camino Hospital's Genomic Medicine Institute will form a centralized tumor board that will study the results and consult with patients' oncologists on how to use them to guide their treatment.
The new study follows a research trial that Life Tech, TGen, and US Oncology announced earlier this year (IS 3/9/2010). For that study, the partners are going to sequence and analyze the genomes of 14 patients with triple negative breast cancer whose tumors have progressed despite multiple therapies, and compare their progression-free survival with 14 control patients whose tumors are not sequenced. Lucier said enrollment for the breast cancer study is currently underway.
Life Tech is the primary sponsor of the new initative and is currently assessing its financial needs, based on protocols and parameters under development. The company said it welcomes additional funders to join the initiative, which would enable it to grow and enroll more patients.
"We strongly believe that genome sequencing will allow physicians to treat their patients not just based on the type of cancer they have, but on the biological pathways that led to mutations which ultimately resulted in the development of cancer," Lucier said in a statement. “We look forward to exploring how sequencing can provide the medical community with more specific, accurate data that can help guide cancer treatment options."
During his talk, he added that Life Tech will pay for the treatment if one of its 9,000 employees who enrolls in the study is treated with an off-label drug that is selected based on the genetic profile of his or her cancer. "These will be patients that have exhausted all other therapy — we think this is the right thing to do," he said.