As oncology care continues to advance, numerous groundbreaking precision therapies have gained approval in recent years. Since Keytruda (pembrolizumab) became the first drug approved for a tumor-agnostic indication (MSI-high) in 2017, several histology-agnostic approvals across multiple disease states have followed. Last year, Rozlytrek (entrectinib) became the third cancer treatment approved by the FDA based on a commonly expressed biomarker.
The expansion of molecular targets and genomic understanding of carcinogenesis is redefining precision medicine to the extent that protein/gene analysis is being performed for nearly every advanced cancer. Next generation sequencing (NGS) is at an inflection point, where it no longer serves as a last resort when all standard therapies have failed but is required before initiating the first systemic therapy for a metastatic cancer.
We can expect this trend to continue in 2020 and beyond: IO drug predictive testing will move from PDL-1 expression to tumor mutational burden (TMB) and other gene profiles, an explosion of additional tumor-agnostic treatments will be approved, and a greater understanding of existing biomarkers, e.g., BRCA in Pancreatic cancer, will expand their use in pre-treatment testing. In order to determine the right drug for the right patient at the right time, adoption of earlier use next-generation sequencing testing will be required. Currently, many community oncology practices face significant hurdles in employing NGS. In the June 2018 issue of Oncology Insights by Cardinal Health Specialty Solutions, oncologists cited difficulty interpreting results, a lack of clinical evidence to support the use of NGS and how the high cost of these tests will impact patient copays as the main barriers to adoption. The paradigm shift for early NGS will require the buy-in of all stakeholders and evidence that it provides the best clinical and financial outcomes.
Regardless of the methods being used to identify potential candidates for precision treatments, continued refinement and personalization in oncology is likely to transform all systemic drugs into targeted therapies. The new standard of care will require that all metastatic cancer patients undergo biomarker screening, meaning practices will need to implement and deploy the right diagnostic tools to meet the demand. We believe artificial intelligence (AI), automated, real time, point of care decision support, virtual tumor boards, automated benefit investigation and prior authorization support will be introduced to support this demand. As if that weren’t enough, new financial modeling like value based contracts will emerge to address the financial impact to payers, providers and patients. It will truly be a brave new world in cancer care.