On the eve of a $21 billion acquisition by medical device and pharma giant Abbott Laboratories, cancer screening company Exact Sciences is digging deeper into genetic testing that could fulfill the promise of precision oncology medicine and help drugmakers bring new treatments to the table.
Exact recently launched its Riskguard hereditary test designed to detect genetic risk for 10 tumor types including breast cancer, which remains the most commonly diagnosed cancer in the world. Riskguard includes what the company calls the STAT breast cancer panel, which chief medical officer of precision oncology Dr. Rick Baehner said will help doctors prescribe the most effective treatments as soon as possible.
Predictive tests like these provide the insight researchers need to find new targets and develop drugs that cut to the chase more quickly than broader interventions like chemotherapy and surgery. They also add to a growing body of population-level evidence that drugmakers can use to understand the intricacies of certain cancer types.
Other ties between Big Pharma and diagnostics companies include a $200 million licensing deal between Roche and cancer blood test maker Freenome last year.
The information gleaned from these tests, especially for the many types of breast cancer and the specific drugs designed for each one, contributes to more individualized treatment plans and better outcomes, Baehner said.
Here, Baehner explains Exact’s growing arsenal of genetic tests for breast cancer, the move toward precision medicine in oncology and the next generation of treatments on the horizon.
This interview has been edited for brevity and style.
PHARMAVOICE: How does the ongoing genomic revolution fit into what Exact Sciences’ aims to accomplish in oncology?
DR. RICK BAEHNER: It’s clear that you need a genetic test to understand baseline hereditary risk and whether those genes will impact the extent of surgery a patient needs. What we’re really trying to do is put together a platform that enables physicians to make seamless clinical decisions. What we hear from them is that they need to remove the friction of filling out forms and preserving tumor tissue. And we’re seeing maturation, particularly in breast cancer but also across multiple tumor types, where hereditary risk cancer testing and understanding molecular residual disease with comprehensive genomic profiling are critically important in developing the evidence as guidelines for physicians.
How has the breast cancer treatment landscape changed with the knowledge gained through screening processes, new biomarkers and genetic tests?
Over the course of 25 years or so, the identification of different types of breast cancer — ER positive or luminal, HER2-positive, triple negative, basal type — and the particular genes that are over- or under-expressed has given us the ability to conduct clinical trials that integrate genomic markers and significantly reduce the amount of chemotherapy being offered to patients. We’ve seen an evolution in targeted therapies like PARP inhibitors, and what’s exciting about that is their efficacy is founded upon identifying mutations in BRCA genes and how they evolve within a tumor. That’s an example of a biomarker having a meaningful impact on top of standard chemotherapy.
And there are examples across the board of incredible therapies in HER2-positive breast cancer. Trastuzumab [Roche’s Herceptin] was a game changer in targeting that receptor, and we’ve increasingly seen the development of ADCs where chemotherapy can be tethered to that monoclonal antibody model and be delivered more effectively, as well as immune checkpoint inhibitors in triple-negative disease that have led to incredible improvements in survival. Those two types of cancer in particular were very grim in terms of their outcomes.
How do these advances play into the overall healthcare landscape, particularly with regard to saving time and money getting patients to the correct treatment earlier?
[Exact’s] Oncotype [DX Breast Recurrence Score Test], [which I] worked on when we developed it 20 years ago … recently passed 2 million patients and has played a pivotal role in personalizing breast cancer care. We estimate we’ve helped about 1.6 million patients safely avoid potentially unnecessary chemotherapy. If you look at the savings impact, you’re talking billions. In the U.S. alone, real-world evidence shows us that it could have saved more than $14 billion to the American healthcare system. As the only predictive test on the market for adjuvant and ER-positive breast cancer treatment decisions, identifying which patients are going to benefit and which aren’t is critical for payers and regulators who require two decades of clinical evidence in these large trials. It’s that type of broad evidence across a wide variety of patients that’s foundational to de-escalate care with a huge impact on savings.
How does a diagnostics company like Exact work with drugmakers developing novel treatments?
Companies increasingly rely on Exact Sciences to understand information like genomic findings. They want to know the tumor mutations that are important for their targeted therapy, especially when they’re testing for new targets, and we can provide them the RNA-seq results for a unique snapshot of what’s happening inside tumor cells. That allows them to maximize the amount of information they’re getting from a tumor sample to inform their trials and then conduct the next generation of research to develop pharmaceutical agents.
That happened in lung cancer, for example, where it started off with just histologically differentiating non-small cell versus small cell, and then recognizing the particular cell type not only for specific drugs that were being developed but also to hypothesize whether drugs for other tumor types could potentially be useful. The HER2 mutation in lung cancer is a great example, and now there are over 10 targeted therapies. The same questions are being asked in colorectal cancer, and this broader understanding of a tumor in the context of testing a single marker and a drug provides fertile ground for understanding synergies in therapies across tumor types.
What are the most exciting changes incorporating gene sequencing and other cutting-edge technologies in oncology?
As we think about the future of cancer therapeutics and patient care, molecular residual disease is extremely exciting. It provides another layer of insight to identify patients at elevated risk of [disease] recurrence, and that information is not only useful for the physician today but to see if someone is developing metastatic disease in the future. There’s a lot of interest in pharma in knowing who’s very high-risk following standard chemotherapy, and that can be identified via MRD because those patients are ideal candidates as we think about moving therapies from the metastatic setting into the adjuvant setting. There’s a lot of excitement around moving these incredibly powerful targeted therapies earlier.
