Nicholas Robert: Community Oncology Is Driving the Future of Cancer Research

“Precision medicine and targeted therapies have transformed the treatment of cancer for millions of patients in the U.S. and around the world. With the oncology community’s increased understanding of the causes of cancer at the genetic level, precision medicine is enabling clinicians to tailor treatments specific to the patient and their biomarker-driven disease. This radical shift in care has been marked by a move away from a one-size-fits-all approach to treatment and is driven, in large part, by data.

Using data, researchers and clinicians can build databases around certain biomarkers, including mutations, from a broad population of patients to draw important inferences about how each biomarker-defined cancer subtype may respond to a therapy or in combination. The net effect of this advanced research is an ever-broadening range of tumor types and, ultimately, better patient care.

One way to examine outcomes of targeted therapies is by using real-world data (RWD), which relates to a patient’s health status and delivery of care. This information is typically collected from a variety of sources, usually at the point of care in the form of clinical notes, lab tests, radiological images, sensor readings, genomics, operational and financial data. Using an electronic health record (EHR), like McKesson’s proprietary iKnowMed, Ontada can gather anonymized records of patients with similar cancers sharing the same mutation and examines their response to a particular therapy.

The question is, how – and where – can we collect these vast amounts of data and structure it in ways that allow researchers to pull out actionable insights that guide the accurate diagnosis and treatment of cancer?

Therein lies the challenge. One of the greatest problems that healthcare systems face today is that approximately 80% of all data remains unstructured and, given the enormity of processing these data, an estimated 97% of it goes unanalyzed or unused.

For example, Ontada holds more than 150 million pieces of unstructured oncology data, with that number increasing on a daily basis. In the past, this data needed to be processed manually, a laborious process that could not reasonably organize the data in a way that provided key insights for researchers.

Ontada’s recent partnership with Microsoft to use their new Azure OpenAI Global Batch offering is one solution to help efficiently process this incredible volume of data and improve the ability to extract valuable clinical information from it.

While much of the data that guides diagnostic and treatment decisions comes from interventional clinical studies, RWD plays an important role in that it can demonstrate how treatments actually work in practice within a real-word patient population, specifically coming from the community oncology setting. To level set, while some of the clinical research still takes place in academic medical centers, the reality is that approximately 85% of cancer patients in the U.S. receive care in community settings.

For example, a 2021 oncology-based observational study assessed real-world clinical outcomes among patients with c-ros oncogene 1 (ROS1)- positive advanced NSCLC treated with crizotinib, a multitargeted tyrosine kinase inhibitor, in a community oncology setting perfectly illustrates the important role of this RWD.

The real-world population in this observational study was older, had a higher proportion of smokers and had poorer Eastern Cooperative Oncology Group (ECOG) performance status – all considered negative prognostic factors – than those investigated in clinical trials. The outcomes from this real-world, community-based analysis were generally consistent with clinical trial outcomes data, supporting the clinical benefit of this targeted therapy in appropriate patients.

This impact of this shift from the exclusive use of clinical data to an approach that also accounts for real-world evidence is being felt at the regulatory level as well. Between January 2019 and June 2021, 85% of U.S. Food and Drug Administration (FDA) approved applications for new drugs had incorporated RWE in some form, and more than half of those approvals noted that the RWE influenced the FDA’s final decision.

This is particularly relevant for rare cancers, where interventional trials are not always feasible due to small patient populations, with is magnified by today’s biomarker-driven approach to cancer research. This approach was demonstrated by the 2019 FDA approval of alpelisib, the first therapy for hormone receptor–positive/HER2-negative advanced or metastatic breast cancer with a PCK3CA mutation, a cancer that affects just 14 of every 1 million individuals.

Recognizing that a randomized clinical trial would be difficult to conduct, the agency attributed RWE as a factor in its decision to approve this targeted therapy.

Given the potential for RWD to supplement clinical data in driving research in rare cancers, the FDA selected Ontada in 2023 to conduct a study designed to advance the use of RWD in the U.S. community oncology setting. The goal of this research is to enhance understanding of how patients with rare cancers present and are treated in order to inform drug development for life sciences companies and the FDA.

In this project, Ontada will use RWD from the iKnowMed electronic health records (EHR) system to study the natural history of patients with rare cancers in U.S. community cancer practices and compare results with other data sources, including national cancer registries, to gain a comprehensive understanding of how best to interpret the findings.

As the oncology community continues to gain more insight into the various subsets of cancers, from the most common to the rarest subtypes, the value of community-based RWD cannot be understated. It already has demonstrated to be a powerful tool for researchers as they look to validate the benefits of targeted therapies in real-world settings and as they explore the next generation of treatments that promise better outcomes for individuals living with these cancers.”

written by Nicholas Robert
Chief Medical Officer at Ontada

Dr. Nicholas Robert, Chief Medical Officer at Ontada, a McKesson company, specializes in oncology data and real-world insights. He previously served as Medical Director for McKesson Specialty Health, Vice President of Medical Affairs at McKesson, and held leadership roles at Virginia Cancer Specialists and Tufts Medical Center, focusing on clinical oncology and research. With over 150 publications, he is a member of ASCO and ISPOR, focusing on improving biomarker testing and advancing precision oncology through collaborative efforts across healthcare sectors.