Quintiles is collaborating with US Oncology Research, a community-based research network specialising in Phase I–IV clinical trials for cancer, on an observational study of genomic ‘pre-profiling’ as a means to inform physician treatment decisions – including better targeting of patients for clinical trials.
The initiative is part of a broader strategy at the US-based provider of biopharmaceutical development and commercial outsourcing services to enhance the development of biomarker-guided therapies for cancer.
Early indications from the study suggest that pre-profiling could provide physicians and patients with early visibility on potentially actionable biomarkers within a two-week timeframe.
“This level and speed of analysis has promise to save valuable time in administering potentially life-saving therapies to patients, and reduce the development times of precision medicines,” commented Dr Jeffrey Spaeder, Quintiles’ chief medical and scientific officer.
Feasibility study
According to the registration details on the ClinicalTrials.gov database, the Feasibility Study of Biomarker Analysis for Patients With Metastatic Colorectal Cancer aims to enrol a total of 60 patients with colorectal neoplasms or advanced metastatic colorectal cancer (mCRC).
The study, which is supported by McKesson Specialty Health and The US Oncology Network, has a scheduled completion date of August 2014.
Tumour-tissue samples will be taken from these patients to determine the number of genetic changes in mCRC that are already targeted by cancer therapies approved by the US Food and Drug Administration, as well as those targeted by therapies in development.
The study will perform a broad-based biomarker analysis on mCRC patients, Quintiles explained. Results will then be reported to the treating physicians “in a clinically meaningful format to help identify higher-risk patients and aid in selecting better treatment options”.
Sequential approach
As things stand, Spaeder noted, the biopharmaceutical industry’s approach to stratifying patients through genomic screening is sequential – “testing for oncology biomarkers one at a time, and often only as part of screening for participation in a single clinical trial”.
Genomic pre-profiling may accelerate early testing of new biomarker-targeted therapies by enabling companies to focus on molecules with high potential for safety and effectiveness, Quintiles pointed out.
For cancer patients and physicians, pre-profiling enables efficient matching of the right patients to the right clinical studies, while expanding patient access to innovative therapies, it added.
“Our work is taking a critical step toward making precision medicine a reality,” Spaeder said.
