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Reflections on biomarkers: so far along, so far to go

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Lynn Nye, PhD

December 2019—Presentations at the recent Cancer Biomarkers Conference IV, sponsored by the University of Mississippi Medical Center, prompt reflection on how far we have come since the introduction of Rituxan, the first monoclonal antibody to be approved by the Food and Drug Administration for the treatment of cancer in 1996. Before the launch of Rituxan, physicians were skeptical about the efficacy and safety of monoclonal antibody therapy because of the history of failures. In the early days, nurses had to learn how to manage the short-term side effects related to the IV infusion. But patients, many of whom I met, had exhausted all of their treatment options for non-Hodgkin lymphoma, and Rituxan gave them a new lease on life. At the time, because of the skepticism, it was hard to see the big opportunities for monoclonal antibody therapy and for Rituxan in the multiple indications for which it was subsequently approved.


Commentary


Dr. Nye

Today, almost a quarter of a century later, targeted monoclonal antibodies as well as small molecules are standard therapy, extending overall survival for many cancer survivors. At Cancer Biomarkers Conference IV in October, researchers from most of the major academic centers in the United States presented the latest findings in biomarkers and advances in targeted therapy. Many of the presentations focused on targeted therapy, using small-molecule tyrosine kinase inhibitors, immunotherapy by means of treatment with the checkpoint inhibitors PD-1 and PD-L1 monoclonal antibodies, and drugs that target the genetic abnormalities ALK, EGFR, BRAF, ROS1, and, most recently, NTRK. It was evident from discussions with the audience of pathologists, oncologists, and patient advocates that our understanding of disease mechanisms and associated biomarkers is advancing at an exponential pace that is making it difficult for the oncology community to keep up.

Although some patients are benefiting from these new discoveries, many challenges remain, as with the introduction of Rituxan. How do we make sure every patient receives biomarker testing and the appropriate first-line and subsequent therapy? Is there a way to predict which patients are likely to have severe and possibly fatal side effects from immunotherapy, and how can we mitigate the side effects? Should we perform next-generation sequencing on every patient to better understand the treatment options when a patient relapses on a specific targeted therapy?

In the late 1990s, Genentech funded the National Coalition for Cancer Survivorship’s development of the Cancer Survival Toolbox, a unique self-advocacy program for cancer survivors. We have worked on this program for more than 20 years, and over the years almost every major pharma company has supported its production and distribution. That the Cancer Survival Toolbox has been accessed by more than a million cancer survivors and is still available today is evidence of the importance of self-advocacy.

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