Global Implementation of Precision Oncology

Abstract

Advances in sequencing technologies have provided unprecedented insights into the molecular landscape of tumors. With next-generation sequencing (NGS), comprehensive molecular profiling of tumors can be generated expediently and at a fraction of the costs associated with traditional sequencing methods. On the shoulders of these scientific advances in sequencing technology, genome-driven therapy has been pushed to the forefront of cancer medicine (precision oncology). Since cancer is a disease driven primarily by alterations in the genetic code, it follows that identifying specific alterations driving the malignant process should fuel the development of novel therapeutic strategies. Therein lies the concept of precision oncology—an opportunity to personalize care, with the promise of greater efficacy with less toxicity for the individual patient. Indeed, for a number of patients, this dream has been fulfilled with the recent regulatory approvals of targeted and immunooncology agents in a histology agnostic setting, including the approval of the TRK inhibitor, larotrectinib, for patients with TRK fusion–positive solid tumors and more recently the approval of pembrolizumab for patients with tumor mutational burden–high solid tumors. Further, targeted therapies previously approved in a histology-specific setting, such as BRAF inhibitors in melanoma and trastuzumab in human epidermal growth factor receptor 2 (HER2)–positive breast cancer, have demonstrated promise in other tumor types harboring the relevant alterations, leading to regulatory approvals in these settings. However, critics of precision oncology have questioned the costeffectiveness of large-scale implementation of NGS as a means to improve outcomes for patients with cancer. Indeed, rising healthcare costs are a significant concern, especially in countries with a universal health insurance system where budgetary limitations are an important consideration in care delivery.