3 oncology trends for 2020 and beyond

 

The past decade saw unprecedented clinical developments in cancer medicine, reshaping the field as we know it. These exciting and promising innovations have ushered in a new era of oncology patient care and with it, new opportunities for community oncology practices.

As a new year and a new decade begins, here are three treatment and technology trends that we believe will have major implications in 2020 and beyond.

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.

Artificial Intelligence (AI) and machine-learning technology have been quickly integrated across a wide number of industries and it is rapidly being deployed in healthcare. A 2019 survey of 500 hospitals, health plans, life science companies and employers found that 62 percent of organizations have implemented AI strategies—an increase of nearly 88 percent from 2018. Oncologists have expressed enthusiasm for implementing AI in their practices and believe that will have a significant impact over the next few years. The June 2019 issue of Oncology Insights by Cardinal Health Specialty Solutions reported that more than 50 percent of participating oncologists are excited about AI’s potential to support care and enhance practice efficiency, and they cited identifying treatment paths, predicting patients at risk of complications and improving diagnostic tools as the greatest opportunities for using AI.

VitalSource™ GPO practices who have deployed the Jvion Machine, an AI-powered tool, have reported impressive results. Using the Jvion machine, practices have been able to better identify patients at-risk of 30 day mortality who would have been missed by conventional predictive analytic approaches. These results have enabled them to deliver more coordinated, comprehensive patient care.

As AI tools become more common, integration with current EMRs presents a challenge. Many current EMR platforms don’t readily support this functionality, but we anticipate that vendors will quickly adjust. With the total cost of cancer care likely to reach $174 billion this year, current diagnostic practices may no longer be sustainable, as we alluded to above. AI and machine learning have tremendous potential to reduce waste while driving improvements in evidence-based medicine and more efficient, smarter workflows.

The FDA has stated that cell and gene therapy approvals are anticipated to expand significantly in this new decade, estimating that they will likely approve up to 20 cell and gene therapies of the nearly 300 currently in development by 2025[1]. While the FDA has approved two CAR-T therapies for treating B-cell lymphoma to date (targeting CD19), we anticipate that the indications for these products and newer products targeting CD19 will be expanded to treat additional B-cell Non-Hodgkins Lymphomas, including follicular lymphoma, and mantle cell lymphoma.

With over 300 CAR-T clinical trials actively accruing, it is likely that the field will expand dramatically. Newer CAR-T agents targeting CD19 with improved toxicity profile may potentially be approved in the near future. We also anticipate that new CAR-T approvals will expand into more common hematologic malignancies, such as multiple myeloma. Beyond 2020, we expect the CAR-T principle to be applied to certain solid tumors which can lead to a remarkable shift in the treatment paradigm given the higher incidence of solid tumors. Another distant trend is the development of “off-the-shelf” CAR-T therapies, which would shorten the time needed to develop autologous product, a current impediment to CAR-T therapy.

The promise of gene therapy as a potentially curative option for chronic lifelong diseases is being realized in hematological conditions such as beta thalassemia. Additionally, treatments for other hematologic diseases—including Hemophilia A and B, Sickle cell anemia and rare conditions that cause immunodeficiency such as Wiskott-Aldrich syndrome, Chronic Granulomatous Disease (CGD) and Severe Combined Immunodeficiency (SCID)—are currently undergoing gene therapy trials in advanced phases.

With new benign hematology therapies coming to market, hematologists and oncologists may be unaware of new treatments, which could potentially result in these new therapies being underutilized, hindering adoption and improved outcomes for patients, particularly those with non-malignant hematologic disease.  

Multiple gene therapy trials are ongoing in a variety of solid tumors as well especially in cervical, bladder, melanoma and glioblastoma. While there are currently only a handful of FDA-approved cellular and gene therapies, there are hundreds of clinical trials under way in oncologic, neurological, cardiovascular and ophthalmologic conditions, almost half of them focused on solid tumors or hematologic indications. As these are approved, the treating oncologists and hematologists will learn to utilize and manage effects of this new class of drugs.   

These therapies represent a monumental shift in medicine—from simply managing symptoms to curing these chronic diseases. While these revolutionary therapies have demonstrated impressive outcomes, they present a new set of real-world challenges that community practices will need to navigate.

Clinicians will need to increase their awareness and understanding of these new therapies as they come to market. A recent survey by Cardinal Health Specialty Solutions shows one in five oncologists do not know enough about CAR-T therapy to prescribe it. With most patients beginning their cell and gene therapy treatment journey in the community setting, this lack of awareness may hinder overall adoption of these therapies.

The population of patients eligible for CAR-T therapies currently on the market is still relatively small; however, the likelihood of broader indications for more common cancers may result in increased volume. Understanding these therapies and creating streamlined flows for moving patients from referral to recovery will likely be a need for community practices going in the future.

With these revolutionary advances in cancer treatment, the outlook for oncology and hematology patients may be improving. Yet, as the standards of patient care rapidly change, the burden will be on physicians to implement a dynamic treatment landscape. Rather than broadly treating all cancers with a set number of therapies, personalized medicine is moving us closer to getting the right drug to the right patient at the right time. Such a paradigm shift will require insights generated from artificial intelligence that have the potential to greatly enhance diagnostic capabilities and treatment pathways that incorporate both precision medicine and cell/gene therapies. For forward-thinking oncology practices, now is the time to understand how these emerging fields will reshape oncology care and take action to ensure their practices are ready to take advantage of the opportunities they present.

1. Statement from FDA Commissioner Scott Gottlieb, M.D. and Peter Marks, M.D., Ph.D., Director of the Center for Biologics Evaluation and Research on new policies to advance development of safe and effective cell and gene therapies, FDA, January 15, 2019