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Quintiles’ Study Offers View of How Pre-screening for Personalized Cancer Treatments Would Work

How do you match up the appropriate patient with the right drug and implement treatment rapidly? That is a question at the heart of personalized medicine and the focus of a study by Quintiles to develop best practice.

In a study of patients with colorectal cancer, it’s investigating how pre-profiling and genomic sequencing data, including the number of genetic changes that occur, could support physician treatment decisions, including the identification of appropriate clinical trials for patients. The Feasibility study of Biomarker Analysis for Patients with Metastatic Colorectal Cancer is expected to go on for 10 weeks. US Oncology Research is participating in the study and it’s supported by McKesson Specialty Health and the US Oncology Network.

The tumor analysis and assessing the bioanalytic requirements is done in Quintiles labs in Durham, North Carolina. Those observations and assessments are being packaged into a report for physicians.

In a phone interview with Quintiles Chief Medical and Science Officer Jeffrey Spaeder, he said: “Instead of looking at just one biomarker and method of action and determining if the patient is appropriate for inclusion in a study, we are looking at a much larger number of genomic variants and allowing the healthcare provider and patient to make more informed decisions about [which treatment to go forward with.”

It’s about matching FDA-approved therapies, as well as therapies in development that have a specific benefit-risk profile for specific patient populations. Instead of bench to bedside, it’s more like bedside to bench and back again.

Spaeder said: “We have the capabilities to do this appropriately and think it is a new way of providing information to the treatment of patients and clinical research.”

Many groups see the benefit of personalized medicine since, based on our genetic makeup, two people with the same condition are likely to respond better to one treatment than another. But one of the challenges has been how to implement that approach. The Quintiles study represents an important piece of that puzzle.

Source: MedCity News

Quintiles Asks, ‘Why Not Test for Many Biomarkers at Once?’ When Evaluating Therapies for Cancer Patients

Calling the concept “pre-profiling,” Quintiles (Research Triangle Park, NC) is collaborating with US Oncology Research (the research arm of McKesson Specialty Health) to test the value of running multiple biomarker tests at once for cancer patients—in this case those with metastatic colorectal cancer (mCRC). Either for initial therapy, or as a step to selecting candidates for clinical trials, the current practice is to look for genomic data that is relevant to one type of therapy; if the suitable genomic variant is found, the clinician then knows that the patient is a good trial candidate, or that the patient could benefit from a specific therapy. Quintiles is suggesting to look at many variants or makers initially and then make treatment or trial recruitment decisions.

In practice, says Dr. Jeffrey Spaeder, CMO at Quintiles, a biopsy would be retrieved from the patient, DNA and other genomic information sequenced, abnormalities identified, and bioinformatics analysis conducted, then returning the results back to the clinician. “All these steps sound intuitively straightforward, but they involve complex handoffs of information and clinical decisions,” he says. Understanding what the clinician can do with the data needs to be determined; what choices the patient might have for one therapy or another; and in the final analysis, whether better outcomes could be achieved remain to be evaluated. Eventually, the multiple-biomarker process could become a step in the clinical pathways that various organizations have developed for treatment of cancers. “Early indications from this study suggest that we can provide physicians and patients with early visibility on potentially clinically actionable biomarkers within a rapid 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.”

The biomarker field, while demonstrating exciting new potential and spurring the evolution of personalized (or “precision”) medicine, is fraught with operational difficulties. Insurers are selective about what biomarker tests they are willing to pay for; practitioners have varying enthusiasm for the tests, and the clarity around which tests lead to beneficial outcomes are not clear. Even so, this study could be one of a series of medical innovations to make biomarkers a standard element of cancer therapy.

Source: Pharmaceutical Commerce