ASCO panel: Precision medicine in practice can be challenging – what we should all know . . .
February 7, 2018
ASCO – Highlights from an article on Immunotherapy and Precision Medicine:
Precision medicine encompasses at least three areas, including:
next-generation sequencing of tumor DNA leading to targeted therapies;
creating subsets of various diseases, allowing for greater prediction of outcomes; and
immunotherapies, including vaccines and engineered cellular therapies.
Precision medicine has been marked by FDA approvals of gene mutation-specific treatments, such as afatinib (Gilotrif, Boehringer Ingelheim) — an oral, once-daily EGFR tyrosine kinase inhibitor — which is indicated for the first-line treatment of patients with non-small cell lung cancer whose tumors have certain EGFR mutations.
“For a long time, people thought that [immunotherapy and targeted therapies] were two entirely different fields, and people were working in isolation at the beginning,” Suzanne Topalian, MD, melanoma program director at Johns Hopkins University, said during the panel. “I’m an immunologist; I didn’t know that there were many people working on molecular biology and targeted drugs. There are a lot of intersections between these two areas, and I think the hallmark of this intersection came last May when the FDA had a landmark approval to give immunotherapy to patients who had a genetic marker in their tumor. That is the intersection — the meeting of cancer genetics and cancer immunology.”
For effective implementation, precision medicine in practice requires the intersections of several fields and key elements, such as genomic testing facilities, according to panel moderator Richard L. Schilsky, MD, FASCO, FACP, chief medical officer of ASCO.
Determining the right test
Because there are many genetic tests available, clinicians may have a difficult time determining the right test.
“There are a lot of genetic tests out there, and they range from testing for a specific alteration and a specific gene to these large panel tests that report out findings on many hundreds of genes all at the same time,” Schilsky said.
Guidelines from the National Comprehensive Cancer Network and other professional groups can help direct physicians to the best genetic tests, according to Anna B. Berry, MD, pathologist and scientific director of the personalized medicine program at Swedish Cancer Institute in Seattle.
Genomic tests must be Clinical Laboratory Improvement Amendments-approved, and many are College of American Pathologists certified, although this is not a requirement.
Just like with drug products, clinicians should be cautious about genetic tests being offered and should evaluate them carefully, according to Berry.
When a company offers a genomic test, “clinicians should say, show me your validation data; show me how you’re meeting all the parameters that you should be meeting,” Berry said. “Aside from that, clinicians need to look at the report. What kind of information are you giving back to me?”
Some genomic testing reports include information on hundreds of genes, which can be overwhelming for clinicians.