Precision Medicine in Oncology®

Steven A. Rosenberg, MD, PhD, chief, Surgery Branch, senior investigator, head, Tumor Immunology Section, National Cancer Institute, explains advancements in adoptive cell therapy for the treatment of melanoma.

There is an objectively rational and scientifically valid alternative to evaluate N-of-1 experiences, and there is a critical need for the continued development of such approaches, which the oncology community increasingly recognizes as a necessary step to replace the established but untenable randomized clinical trial paradigm.

One of the most widely talked about trends in healthcare is precision medicine, which uses detailed genetic information about a patient’s cancer to more precisely treat the disease, effectively targeting the tumor. This heightened awareness raises an important question: are precision medicine and pathways compatible?

Frontline treatment with afatinib reduced the risk of progression or death by 27% compared with gefitinib for patients with EGFR-mutant non–small cell lung cancer.

It is simply unrealistic and highly counterproductive to the future of cancer care to believe that the only acceptable approach to determining the absolute or relative clinical utility of a specific drug, regimen, device, or procedure, is through the conduct of a so-called evidence-based randomized trial.

Gargi D. Basu, PhD, senior director of Clinical Curation, Ashion Analytics, discusses a study that examined alterations in the cell cycle checkpoint pathway in patients with breast cancer.

Omid Hamid, MD, Chief, Translational Research and Immunotherapy, Director, Melanoma Therapeutics, The Angeles Clinic, discusses a recent trial investigating the combination of vemurafenib and atezolizumab in melanoma in patients with previously untreated BRAF-positive unresectable or metastatic melanoma.

Gregory Riely, MD Medical Oncologist, Vice Chair, Clinical Trials Office, Department of Medicine, Memorial Sloan Kettering, discusses the benefits and challenges of using next-generation sequencing to identify mutations in lung cancer.

With the rapid pace of change in precision medicine, insurance companies and federal policymakers are going to have to adjust for far more variance in the ways patients are treated, even though insurance plans and federal policy by nature require a measure of standardization.

Mark R. Gilbert, MD, senior investigator, chief, Neuro-Oncology Branch, National Cancer Institute, Center for Cancer Research, discusses the use of precision medicine in treating patients with glioblastoma.

The deployment of precision medicine to develop safe and effective therapies to treat malignant brain tumors is an effort that poses both opportunities and challenges.

Jason Luke, MD, Assistant Professor of Medicine, the University of Chicago Medicine Comprehensive Cancer Center, discusses how inflammation in the tumor microenvironment can serve as a biomarker in melanoma.

The FDA has requested additional clinical trial data to support a new drug application for rociletinib as a potential therapy for pretreated patients with EGFR T790M mutation-positive NSCLC.

The FDA has granted an accelerated approval to osimertinib for patients with advanced EGFR T790M mutation positive non–small cell lung cancer following prior therapy on a prior EGFR TKI.

Geoffrey R. Oxnard, MD, Assistant Professor of Medicine, Harvard Medical School, Dana Farber Cancer Institute, discusses how to define resistance to EGFR-inhibitors in lung cancer.

Treatment of patients with non–small cell lung cancer should be based on the identification of rare molecular targets such as BRAF, RET, ROS1, and MET versus clinical characteristics.

Less than a decade after the FDA set the ground rules for developing assays that pair molecular targets with new drugs, experts say there have been strides in personalizing anticancer therapies but that many hurdles remain before next-generation sequencing and other precision medicine advances are incorporated into the diagnostic paradigm.

Pazopanib demonstrated significant clinical activity for patients with RAI-refractory differentiated thyroid cancer; however, a predictive biomarker for the therapy could not be uncovered.