Originally published June 3.
By Turna Ray
BOSTON — A new pharmacogenomic alliance kicked off this week with the aim of personalizing the care of cancer patients with data gleaned from their whole genome sequences
The Genomic Cancer Care Alliance — which currently involves Fox Chase Cancer Center, Scripps Genomic Medicine, Omicia, El Camino Hospital, and the Translational Genomics Research Institute — plans to launch a pilot study to investigate the ability of whole-genome sequencing to guide treatment for patients who have difficult-to-treat cancers and have responded poorly to initial therapy.
Life Technologies is providing the primary funding for the study. Though the participants did not disclose the amount of support the company has provided, Life Tech CEO Greg Lucier estimated at the Consumer Genomics Conference here today that that the study will cost “several million dollars.” He added that the target is to enroll 100 patients initially, possibly even Life Tech employees with cancer.
In a statement, Life Technologies said it is currently assessing the financial needs of the study as the protocols and parameters are established. The company also urged additional sponsors to join the initiative, which would enable researchers to enroll a greater number of patients.
Fox Chase Cancer Center, TGen, and El Camino will be involved in patient enrollment and will provide clinical care sites for the study. US Oncology will serve as the study's contract research and site management organization.
Enrollment for the pilot study will begin in the latter part of this year. Protocols for the study are currently under development.
As plans for GCCA's pilot study are ironed out, it is likely that enrollees will have their tumor and normal tissue sequenced by TGen, Scripps, and other research institutions using Life Technologies' SOLiD System to identify specific cancer mutations.
Researchers will validate results at a CLIA-certified lab that has not yet been identified. The data will be analyzed by TGen and genomic sequence interpretation firm Omicia. Additionally, a centralized tumor board for the study, involving physicians from Fox Chase Cancer Center, TGen, Scripps, and El Camino Hospital’s Genomic Medicine Institute, will consider the results and develop personalized treatment strategies with patients and their oncologists.
Life Technologies emphasized that the goal of the study is to work with the patients' doctors, and the intent is not to “usurp the physician’s role,” but to provide doctors with additional information through whole-genome sequencing to help them make treatment decisions for their patients.
“This is a groundbreaking initiative for oncologists and their patients that should demonstrate how whole-genome sequencing with analytics and counseling can identify a treatment plan customized specifically for each seriously ill patient,” Paul Billings, GCCA's chief medical officer and the chief scientific officer at the Genomic Medicine Institute at El Camino Hospital, said in a statement. “There is an urgent need to define and validate a complete medical workflow for genomic-based cancer care.”
Life Technologies' work with GCCA is an expansion of an effort announced in March in which the company, TGen, and US Oncology are sequencing the whole genomes of 14 patients with triple-negative breast cancer whose disease has advanced despite treatment. The current effort with GCCA will not just focus on breast cancer but on a wide range of cancer malignancies.
It is currently unclear whether the treatment for cancer patients identified by whole-genome sequencing data to be responsive to an off-label drug will be covered by their insurers.
Life Technologies said that if any of its employees participate in this study, the company will pay for off-label treatments recommended by researchers and their treating physicians. Lucier estimated that each year, within the 9,000-employee company, between 30 to 40 will get cancer.
The company also cited the 2009 Bisgrove breast cancer trial — a study led by TGen that used molecular profiling to identify targeted therapies for 66 cancer patients — and pointed out that “nearly all” patients' insurers agreed to cover the course of treatment recommended through the study.
Bisgrove, which used microarrays to profile patients' gene expression, was ultimately successful in improving patient survival rates.
Several of the institutes involved in GCCA are already invested in advancing genomically guided personalized medicine. Scripps Genomic Medicine, a program of the Scripps Health organization, is focused on using genetic information to create individual treatment plans. Additionally, in 2008, the Scripps Translational Science Institute announced that it was joining forces with Navigenics, Affymetrix, and Microsoft to conduct a 20-year study investigating whether arming individuals with their personal genomic information will motivate them to make preventative lifestyle changes or seek medical care (PGx Reporter 10/17/08).
The Genomic Medicine Institute at El Camino Hospital, meantime, is attempting to integrate the genomic data of patients presenting at the hospital located in Silicon Valley. The institute is working with DNA Direct to counsel patients about how their genomic data can impact their healthcare (PGx Reporter 04/01/09).
More information about enrollment in the study will be made available through GCCA in the coming months.