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Prostate and Urological Health

Breaking Down the Biggest Developments in Precision Medicine

Brian Alexander

Physician and Chief Medical Officer, Foundation Medicine

The field of precision medicine is constantly changing and evolving. We sat down with Brian Alexander, physician and chief medical officer at Foundation Medicine, to talk about the current state of cancer care.

How is Foundation Medicine advancing the field of precision medicine in cancer care?

Cancer is a complex disease of the genome, and from my experience treating patients and leading Foundation Medicine’s research and development team, I believe the more we understand cancer on a molecular level, the faster we can transform cancer care for patients. I’m excited to come to work every day because, at Foundation Medicine, we’re uniquely positioned to lead a paradigm shift in the collective understanding of cancer.

In 2010, we pioneered our breakthrough comprehensive genomic profiling approach to look inside an individual patient’s tumor to find clues about which treatment might be best for her specific cancer according to her unique genomic profile. Now, our tests analyze the tumors of thousands of patients, and we continue to expand our offerings.

In addition to our tests, we also have the largest consolidated genomic profiling database in the country, FoundationCORE™, which houses more than 300,000 cases. Researchers can examine this database to help answer the countless questions we all have about the molecular underpinnings of cancer, which have potential implications for the way we treat and advance cancer care for patients.

What developments in precision medicine are most exciting to you?

The more we learn about cancer genomics, the more we’re realizing cancer is increasingly defined by genomic signatures of cancer growth, not the tissue of origin. This is evidenced by the fact we continue to see approvals of pan-tumor therapies that oncologists can prescribe based on a tumor’s genomic signature regardless of tissue of origin.

Foundation Medicine continues to explore the role of pan-tumor biomarkers, such as MSI and NTRK, which can be detected by our tests and are now associated with FDA-approved therapies. Additionally, we have led the research in advancing the clinical utility of tumor mutational burden (TMB) as a predictive genomic biomarker for response to immunotherapy. We are involved with a number of ongoing clinical studies with our biopharma partners, including Bristol-Myers Squibb, Merck, and Genentech, to evaluate TMB as a predictive biomarker for response to immunotherapy across multiple tumor types.

Moreover, we are proud to participate in the research and development of therapies that target novel biomarkers like PIK3CA. Recent studies with alpelisib (Piqray), a compound targeting this biomarker, showed promising results in patients with hormone receptor-positive/HER2-negative breast cancer and led to its recent FDA approval.

Liquid biopsy technology is another important development because it can open doors to comprehensive genomic profiling (CGP) for patients who may not be eligible for tissue testing. This is particularly important for patients whose tumors are difficult to access, such as those with non-small cell lung cancer, where up to 30 percent of patients may not have adequate tissue available for standard CGP testing.

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I’ve been hearing a lot of excitement around liquid biopsies. Where does FoundationOne Liquid fit in the treatment paradigm today?

I have seen firsthand that there are patient cases that call for tissue tests and patient cases that call for liquid tests. We believe all advanced cancer patients should receive CGP testing at diagnosis and offer a full portfolio of CGP tests to give all oncologists a range of testing options for their patients. These include FoundationOne®CDx, the first FDA-approved broad companion diagnostic with Medicare coverage for qualifying patients across all solid tumors; FoundationOne®Liquid, our liquid biopsy test for solid tumors; and FoundationOne®Heme for hematologic malignancies and sarcomas.

We believe determining a treatment plan for advanced solid tumors should start with CGP testing at diagnosis, whether it’s tissue-based or blood-based when tissue may not be the best option for the patient. FoundationOne CDx and FoundationOne Liquid are important complementary tools and longitudinal reporting makes it possible to compare results over time, even if two different tests are used.

The next version of our liquid biopsy test received FDA “breakthrough device” designation and, if approved, could be the first FDA-approved liquid biopsy test to incorporate multiple companion diagnostics and multiple biomarkers to provide oncologists with a more complete view of their patients’ cancers.

What data did Foundation Medicine share at ASCO that you were really excited about?

At ASCO, we presented data that further supports the utility of CGP to inform precision medicine in advanced cancer, including data on potential pan-tumor biomarkers FGFR and TMB. We were excited to share the results of a collaboration with Friends of Cancer Research to further characterize TMB as a predictor of immunotherapy response. We also presented data in three subtypes of metastatic breast cancer analyzing the landscape of immunotherapy predictive biomarkers, including TMB.

What do you see as some of the biggest challenges in furthering the field of precision medicine? 

I see expanding patient access to analytically and clinically validated CGP testing as one of the biggest challenges in the field. Currently, only about 12 percent of people with advanced cancer are getting comprehensive genomic profiling, about 26 percent are receiving single maker testing, and about 62 percent are getting no genomic testing at all. This means the majority of people with cancer and their doctors aren’t getting the information they need to make the most informed treatment decisions.

We are committed to improving access and education around CGP so those numbers can drastically improve. We believe CGP is an essential, not optional, component of personalized healthcare, and some cancer treatment guidelines are already suggesting broad molecular profiling. Without it, oncologists do not have the full information they would need to match patients to the growing number of targeted therapies that are newly approved or in clinical trials.

Another big challenge is how to make CGP test results as accessible and actionable as possible for clinicians. We’re addressing this challenge by giving clinicians the results of our CGP tests in an easy-to-read report, which includes information and guidance on result interpretation, as well as clinical and logistical support.

Additionally, our Client Services and Medical Affairs teams have MDs and PhDs available to help oncologists make decisions that could transform patients’ lives. These experts also provide oncologists with a plethora of cancer genomics information like thought leadership, publications, publication updates, monthly webinars, and molecular tumor boards.

Foundation Medicine has more than 50 relationships with biopharmaceutical partners. What solutions do you provide them?

We recognize collaboration is essential to accelerating our ability to help more patients today and in the future. We’ve long partnered with biopharmaceutical companies to discover and study new targets and help advance the development of new treatments. Additionally, when evidence supports approval of those new treatments, our partnerships enable us to develop companion diagnostic tests that can determine patients’ eligibility for these personalized therapies.

Our partners also benefit from FoundationCORE™, which I mentioned is the largest genomic profiling database in the United States with over 300,000 cases, and can be used to accelerate drug discovery and development.

A partnership with Flatiron Health to integrate our world-class genomic data with their leading real-world clinical outcomes data has led to the creation of a clinico-genomic database. This novel database is validated, continuously growing, and currently contains more than 50,000 de-identified matched clinico-genomic profiles, which are already being used by our research partners in both academia and biopharma R&D groups. We are particularly proud that this database predominantly comprises clinical outcomes from community oncology settings reflecting real-world treatment settings.

How are you ensuring all patients have access to CGP testing?

Our CGP tests were designed to bring clinically relevant developments in cancer biology to patients everywhere, including in the community oncology setting. We have teams that support treating oncologists with interpretation of results, clinical, and logistical information so oncologists can truly use the test’s results.

To support our patient-centric mission of advancing cancer care, Foundation Medicine is dedicated to reducing financial barriers that may keep patients from accessing our products, and we offer a financial assistance program to help patients navigate the insurance billing process and reduce the out-of-pocket costs for our tests.

Staff, [email protected]

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