Making CGP indispensable at a global level: progress, perspectives and what’s next

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I initially became an oncologist because, to me, treating cancer provided the biggest opportunity to make a difference for people. I learned quickly that the most valuable tool in treating this disease is knowledge, as each new patient presents with a list of unknowns. An oncologist’s investigations replace those unknowns with data—but the real key to helping a patient is figuring out how to turn that data into actionable insights. Insights that reveal the unique vulnerabilities of a patient’s disease and allow you to predict progression or response, guiding your approach to treatment.

This was the spark that ignited my interest in data and its huge potential in oncology. It has become a passion that has shaped my career path and I feel privileged to now be in the position of leading an organization like Foundation Medicine, which has been at the forefront of data-informed precision oncology for more than a decade.

From my perspective, since it was discovered that cancer is a disease of the genome, it has been clear that molecular profiling would one day be an indispensable part of cancer care and research. Comprehensive genomic profiling (CGP) provides a broad picture of the mutations, alterations, and interdependent pathways that characterize and drive a patient’s cancer. That data not only gives us the power to transform outcomes for individual patients; it delivers invaluable insights that help shape cancer care for patients in the future.

But the true potential of CGP can only be realized if we can successfully bring it to patients. We’ve made incredible progress towards this goal in the U.S. and other parts of the world; CGP has become part of the standard of care across multiple cancer types, and our genomic databases continue to deliver knowledge and insights that are transforming cancer care.

But to maintain this progress, we need to make CGP a reality for more patients, with more forms of cancer, in more communities and locations around the world.

Launch of Foundation One Liquid CDx in Japan

One country where we’ve made significant advances is Japan. The Ministry of Health, Labour and Welfare (MHLW) recently approved Foundation One Liquid CDx Cancer Genomic Profile for use in the country, and it is now commercially available for oncologists to use in their treatment planning. This is important news for patients and an exciting demonstration of why collaboration sits at the heart of our global approach.

In 2018 we partnered with Chugai, one of Japan’s leading research-based pharmaceutical companies, to bring CGP to Japanese patients as swiftly as possible. Chugai’s knowledge of the Japanese market and both organizations’ regulatory expertise have already resulted in multiple companion diagnostic approvals for Foundation One CDx Cancer Genomic Profile and most recently, the approval of Foundation One Liquid CDx Cancer Genomic Profile along with several companion diagnostic claims for therapies approved for NSCLC and other solid tumors.

However, bringing the benefits of tissue and blood-based CGP to patients at a local level is about much more than securing regulatory approval. Reaching patients means understanding each individual country’s systems, determining how molecular profiling might fit within a cancer care pathway or standard practice, and identifying and respecting potential barriers from a clinical and cultural perspective.

Our partnership with Chugai has helped us to build a robust understanding of where precision medicine sits in the Japanese oncology landscape, and this has allowed us to refine and adapt our approach and offerings to meet the needs of local physicians, patients, payers, and researchers.

Foundation One Liquid CDx Cancer Genomic Profile is Japan’s first blood-based CGP test that includes companion diagnostic claims, and its availability will unlock the power of precision medicine for significantly more patients across the country. It will also support the development of precision therapeutics in Japan, streamlining research and helping biopharma companies accelerate companion diagnostic development.

Looking beyond the U.S. and Japan

Outside of the U.S. and Japan, we are continuing to build our presence in other regions, including Europe and China. To date, Foundation Medicine’s services are commercially available in more than 100 countries. With over 40 countries in Europe and Asia alone, all with unique healthcare systems, it’s no surprise that local collaboration is fundamental to our approach here too.

As the number and availability of targeted cancer therapies continues to increase, the ability of CGP to change the way we approach cancer will continue to grow and the ability to reach a broader set of patients becomes more urgent.  We’ve partnered with academic centers and biopharma organizations to conduct more than 65 clinical research studies outside the U.S. to advance our global understanding of cancer and how to treat it. We expect this number to grow in the next year.

Through the creation of dynamic, long-term collaborations with global investigators and biopharma partners and by continually building our knowledge base and evolving our profiling portfolio, we are determined to accelerate progress towards our ultimate goal – to transform cancer care by making molecular profiling indispensable for clinical practice and research. By doing so, we will usher in a future where new insights and deeper understanding of the disease will help cancer patients make the most critical decisions of their lives; and that information will provide the foundation for the development of novel therapies that will allow those patients to live longer, better lives.

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