CAMBRIDGE, Mass.—Foundation Medicine Inc., and Chugai Pharmaceutical Ltd., have entered into an agreement with the National Cancer Center (NCC) of Japan for the use of Foundation Medicine’s laboratory-developed liquid biopsy test, FoundationOne Liquid, in the third stage of SCRUM-Japan, the country’s largest cancer genomic screening consortium. Concurrently, a new and improved version of the liquid biopsy test is currently under review by the U.S. Food and Drug Administration (FDA), after having received Breakthrough Device Designation in 2018.
SCRUM-Japan is a multinational program working in collaboration with more than 200 hospitals in Japan and other countries in Asia to provide genomic screening and investigating genomic changes in cancers. It aims to accelerate the development of biomarker-driven precision medicine cancer therapies, and represents a step toward shifting from a paradigm of defining cancer by its site of origin and toward thinking of cancer as a disease of the genome.
“Historically, there’s been a saying that ‘tissue is the issue’—in order to understand a cancer, one needed a tissue biopsy followed by a battery of tests,” says Dr. Prasanth Reddy, vice president of medical affairs at Foundation Medicine. “As technology has evolved, we’ve become better at sequencing the human genome. Tissue-based genomic sequencing is important to decipher the genomic changes in a patient’s cancer, and you can use liquid biopsy to assess those same changes by measuring tumor cells shed into the bloodstream.”
The companies see the liquid biopsy test benefitting researchers in the drug discovery and development space by accelerating and improving basket trials, in which cancer patients are matched to potential therapies based on a specific mutation or biomarker. Using liquid biopsy tests to accelerate the cycle of matching patients to therapies that act on specific alterations can speed clinical trials by helping to accurately identify patient cohorts who will receive benefit from a treatment and helping to encourage patient enrollment, which ultimately may reduce time to market for developmental therapies.
“Drug discovery is often underpinned by biomarker discovery,” says Reddy. “Researchers are asking, ‘how can we design a drug that goes after as specific target?’ A high-quality, extensively validated, FDA-approved liquid biopsy can help researchers to define a target and reduce the risks inherent in companion diagnostic development.”
Liquid biopsy, conducted via a blood draw, is intended to complement tissue biopsy rather than replace it. Tissue-based testing delivers more tumor DNA that can be biopsied; not all cancers and cancer types shed sufficient tumor cells into the bloodstream to be tested. However, liquid biopsy offers several advantages. Tissue heterogeneity can be a challenge for patients with multiple tumors, because different tumor cells can show distinct profiles; liquid biopsy, however, can be used to assess the shed DNA from tumors throughout the body, giving a broader picture of the patient’s disease. In addition, liquid biopsy is minimally invasive, so it can be used to assess patients who are too ill to undergo a tissue biopsy procedure or to evaluate tumors that occur in an anatomical site that may be too risky to biopsy.
“Extensive validation allows a high degree of confidence that the results collected from liquid biopsy are real and actionable,” remarks Reddy.
In April 2018, Foundation Medicine received Breakthrough Device Designation from the U.S. FDA on a forthcoming, next-generation version of the liquid biopsy test, FoundationOne CDX, which is currently under FDA review. In anticipation of the test’s approval by the FDA, Chugai and Foundation Medicine are preparing for the regulatory filing of this version of the test in Japan in the hopes that the product will be approved for use under the country’s universal health coverage. They anticipate that the SCRUM-Japan program will also transition to the FoundationOne CDX test following its anticipated approval by the U.S. FDA this year and subject to the terms of their collaboration agreement.
The next-generation FoundationOne test includes improvements to the test itself and the potential for several additional applications. The new version of the test gives the potential to evaluate blood-based tumor mutational burden as a predictor of clinical benefit, according to a study published in Nature Medicine in September 2018. A BFAST analysis, the results of which were presented at the ESMO Congress 2019, showed that the test can be used successfully to identify DNA mutations in the cells of patients with non-small cell lung cancer suitable for targeted therapies. Additional applications include monitoring a patient’s tumor with a blood test instead of imaging and using a liquid biopsy test post-surgery to determine whether there a patient shows evidence of residual disease.
“There is a critical need for minimally invasive solutions and for getting them to patients,” states Reddy. “We believe this is critical for both patients and their physicians to make the most informed decisions about personalized care.”
Chugai Pharmaceutical, based in Tokyo, is one of Japan’s leading research-based pharmaceutical companies with strengths in biotechnology products, and is a member of the Roche Group. Foundation Medicine, based in Massachusetts, is a molecular information company that offers a full suite of comprehensive genomic profiling assays to identify the molecular alterations in a patient’s cancer and match them with relevant targeted therapies, immunotherapies and clinical trials.