Evolving World of Biomarker Testing and Therapeutic Strategies: Realizing the Promise of Personalized Medicine

For the future of precision medicine, many health care providers hope to see a flood of new therapies for biomarker testing to be approved in the next few months while working as a team with other institutions to address any gaps, according to a session at the virtual 2021 Community Oncology Alliance (COA) Virtual 2021 Conference.

Led by moderator Bobby Green, MD, chief medical officer at Flatiron Health, the panel consisted of Martin Dietrich, MD, PhD, medical oncologist at Florida Cancer Specialists and assistant professor of Internal Medicine, University of Central Florida Cancer Center; Geoffrey R. Oxnard, MD, vice president and global medical lead at Liquid Portfolio at Foundation Medicine; Anthony “Nino” Sireci, MD, vice president, Diagnostics Development & Medical Affairs at Loxo Oncology, Lilly; and Byeong Yoon, executive director of Oncology Global Medical Affairs at Amgen.

When Green asked the panel about calling the tests next-generation sequencing (NGS) or comprehensive genomic profiling (CGP), there was a mixture of responses. For example, Dietrich said there was no standing definition for either as they evolve over time, whereas Yoon explained how it is more important that NGS or CGP provides clinically relevant information rather than just ensuring that is available to the physician.

For Sireci, the importance lies in what exactly you are testing for.

“There has to be an understanding of what the differences are and what is reported,” he said. “We are moving towards a uniform understanding of NGS, but we are not there yet, as we need to work on our part as to what we are actually testing.”

In terms of which patients are being tested, Dietrich went into detail on how there are a lot of data in cancer with immunotherapy and biomarker dependency, which should include an FDA-approved test.

“Every cancer patient that is metastatic should have FDA test attached, especially in the beginning,” Dietrich said. “There is also a lot of cost saving here, as we can do multiple tests on NGS profiles on 1 round of chemotherapy.”

Oxnard said that the more you test the patients, the more value you can get as a provider.

“Make it a part of their patient care so that patients can take advantage of this,” he said. “More than 50% of patients recur, so we need to get them so they can use them in the beginning.”

Green mentioned how one-third of cancer deaths would not happen if there were not as many health care disparities. As for potential solutions, Sireci discussed how some of the disparities are driven by payer policy, with many discrepancies between public and private payer systems. Yoon said this issue is complex and will need a lot of different groups working together to address the entire continuum of care.

Oxnard suggested that although blood tests have helped, we can do more to stop health disparities, noting that the FDA approval of liquid biopsies will help.

“A vast majority have no co-pays, but making testing available and accessible is in reach,” he said.

On the topic of liquid biopsies, Dietrich said they help but only will help so much. According to Yoon, it is crucial to obtain a quality test to help identify variants. Sireci added that whether you are enrolled liquid or non-liquid, it does not matter as there is always negotiation on the backend.

“We are always trying to meet regulatory requirements, even when trying to help patients as much as possible,” he said.

Looking forward, Oxnard said that the FDA has the power to change the narrative because they have information on how to use biomarker tests, and this could be the tipping point for access to tests. Dietrich said that abolishing the 14-day rule is a start for patients to get the right care and use their therapies immediately.

REFERENCE

Dietrich M, Green B, Oxnard GR, Sireci A, Yoon B. Evolving World of Biomarker Testing & Therapeutic Strategies: Realizing the Promise of Personalized Medicine. Presented at: COA Community Oncology Conference 2021. Presented April 8, 2021. Accessed April 12, 2021.