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PCOC16: Immuno‐Oncology Agents in a World of Precision Medicine

Surabhi Dangi-Garimella, PhD
At the 5th annual meeting of Patient-Centered Oncology Care®, hosted by The American Journal of Managed Care, November 17-18 in Baltimore, Maryland, experts with diverse experiences and backgrounds discussed the contradiction presented by immuno-oncology agents in the world of precision medicine.
For decades, advances in cancer care have struggled with improving patient prognosis and extending survival by weeks or a few months at most, particularly in patients who may have developed an advanced form of the cancer. The advent of immunotherapy, however, has transformed this picture and has even raised the hope of being able to permanently cure these patients.

At the 5th annual meeting of Patient-Centered Oncology Care® (PCOC®), hosted by The American Journal of Managed Care (AJMC), November 17-18 in Baltimore, Maryland, Joseph Alvarnas, MD, associate professor in the Department of Hematology and Hematopoietic Cell Transplantation at the City of Hope in Duarte, California, engaged experts with diverse experiences and backgrounds to discuss the contradiction presented by immuno-oncology agents in the world of precision medicine. Alvarnas is also the editor-in-chief of Evidence-Based Oncology, published by AJMC.

Joining Alvarnas were David Fabrizio, leader of Cancer Immunotherapy at Foundation Medicine, Inc; Sean Khozin, MD, MPH, senior medical officer at the FDA; and David L. Porter, MD, director of Bone Marrow Transplantation and Jodi Fisher Horowitz Professor in Leukemia Care Excellence at the University of Pennsylvania Health System in Philadelphia.

Alvarnas first asked Fabrizio to share his opinion on how a patient’s genomic information could best be exploited in treatments that utilize the immune system and the strategy that Foundation Medicine was working on to improve the efficiency of immunotherapy to develop a standard practice.

According to Fabrizio, using an assay score comes down to the human interpretation of a qualitative score, and it makes it hard to adopt to standard best practices, which leads to genomic solutions. “One such assay is the tumor mutation burden. We do this with [comprehensive genomic profiling, CGP] to understand the number of somatic mutations in a person’s cancer genome,” Fabrizio said. CGP, he added, gives an estimate of how the immune system will respond, and the company has been making strides with looking for more unified methods of analysis.

How can we bring standardization to the diagnostic industry?

“I think standardization is a huge part of the equation,” Khozin said. CGP, he believes, requires a substantially different approach, one that has not been typically available at large organizations, including the FDA. “Academic institutions have more data mining skills…what we need is a new approach to data science to develop predictive algorithms.” Khozin emphasized the important role of the “omics” approach—proteomics, genomics, the entire microbiome—in patient response to therapy.

Porter added that there have been efforts to integrate omics data in the clinic. “We are looking at biomarkers on T cells. A part of this is committing to and being able to have the right samples and tests,” Porter explained. “We are probably missing huge opportunities right now with our clinical trials; we are banking a lot of samples…DNA, RNA etc…but we don’t know how to manage them right now, although we will in the future.” He also added that trial design would change in the future, and that we may have to settle with smaller and more unique subsets of patients.

Khozin added that the FDA is looking into such trial designs, as well. “We don’t have to run a large study, rather leverage [electronic health record] data that is at the point of care.” The FDA has focused its attention on how care can be advanced, especially with immunotherapy increasingly being a part of the equation. The recently commissioned Oncology Center of Excellence (OCE) is working to consolidate oncology functions across the FDA to address the continuum of care in a coherent fashion, Khozin told the audience.



 
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