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Foundation Medicine and Bristol Myers Squibb Expand Partnership to Focus on Companion Diagnostic Development

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Bristol Myers Squibb (NYSE: BMY) has expanded its collaboration with Foundation Medicine to develop the FoundationOne CDx as a companion diagnostic for its investigational tyrosine kinase inhibitor, repotrectinib. This drug is currently under evaluation in the TRIDENT-1 Phase 1/2 trial for patients with ROS1+ non-small cell lung cancer (NSCLC) and NTRK+ solid tumors. If successful, the FoundationOne CDx will help identify suitable patients for treatment with repotrectinib. Foundation Medicine leads in the U.S. with approximately 60% of all companion diagnostic approvals for next-generation sequencing (NGS) testing, enhancing personalized treatment options.

Positive
  • Expansion of collaboration with Foundation Medicine enhances the potential for new treatment options in oncology.
  • FoundationOne CDx aids in identifying patients for targeted therapy, which could improve treatment effectiveness.
Negative
  • None.

Expanded collaboration aimed at developing FoundationOne CDx as a companion diagnostic for Bristol Myers Squibb’s investigational tyrosine kinase inhibitor, repotrectinib

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Foundation Medicine, Inc., a pioneer in molecular profiling for cancer announced today, an expanded collaboration with Bristol Myers Squibb (NYSE: BMY) to develop Foundation Medicine’s tissue-based test, FoundationOne®CDx as a companion diagnostic for Bristol Myers Squibb’s investigational tyrosine kinase inhibitor, repotrectinib.

Repotrectinib is an orally administered TKI (tyrosine kinase inhibitor) being evaluated in an ongoing registrational Phase 1/2 trial called TRIDENT-1 for patients with TKI-naive or TKI-pretreated ROS1+ advanced non-small cell lung cancer (NSCLC) and NTRK+ advanced solid tumors. If the companion diagnostic is approved for these indications, and separately, the therapy is approved, oncologists would be able to use FoundationOne CDx to help identify appropriate patients for treatment with repotrectinib.

Foundation Medicine’s portfolio of FDA-approved comprehensive genomic profiling tests offer physicians blood and tissue-based testing options for detecting genomic alterations that help guide personalized treatment decisions. Currently, Foundation Medicine is the leader in companion diagnostic approvals with approximately 60% of all companion diagnostic approvals for NGS testing in the U.S.

“We’re proud to broaden our collaboration with Bristol Myers Squibb as they work to bring this exciting investigational therapy to patients living with ROS1 positive non-small cell lung cancer and NTRK positive solid tumors,” said Jason Adams, Vice President of Biopharma Enterprise Partnerships, Foundation Medicine. “This new collaboration builds on our ongoing research-driven partnership and furthers our shared commitment to deliver more treatment options to patients who need them.”

About Foundation Medicine: Your Essential Partner in Cancer Care
Foundation Medicine is a pioneer in molecular profiling for cancer, working to shape the future of clinical care and research. We collaborate with a broad range of partners across the cancer community and strive to set the standard for quality, scientific excellence, and regulatory leadership. Our deep understanding of cancer biology helps physicians make informed treatment decisions for their patients and empowers researchers to develop new medicines. Every day, we are driven to help our partners find answers and take action, enabling more people around the world to benefit from precision cancer care. For more information, please visit us on www.FoundationMedicine.com and follow us on Twitter and LinkedIn.

About FoundationOne®CDx
FoundationOne CDx is a next-generation sequencing based in vitro diagnostic device for detection of substitutions, insertion and deletion alterations (indels), and copy number alterations (CNAs) in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue specimens. FoundationOne CDx is for prescription use only and is intended as a companion diagnostic to identify patients who may benefit from treatment with certain targeted therapies in accordance with their approved therapeutic product labeling. Additionally, FoundationOne CDx is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with solid malignant neoplasms. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Some patients may require a biopsy. For a full list of targeted therapies for which FoundationOne CDx is indicated as a companion diagnostic, please visit http://www.foundationmedicine.com/genomic-testing/foundation-one-cdx.

Foundation Medicine® and FoundationOne® are registered trademarks of Foundation Medicine, Inc.

Source: Foundation Medicine

Foundation Medicine:

Erin Smith, 262-914-2779

newsroom@foundationmedicine.com

Source: Foundation Medicine

FAQ

What is the purpose of the expanded collaboration between Bristol Myers Squibb and Foundation Medicine?

The collaboration aims to develop FoundationOne CDx as a companion diagnostic for the investigational drug repotrectinib.

What are the main indications for the drug repotrectinib?

Repotrectinib is being evaluated for ROS1+ advanced non-small cell lung cancer and NTRK+ advanced solid tumors.

What percentage of companion diagnostic approvals does Foundation Medicine hold?

Foundation Medicine holds approximately 60% of all companion diagnostic approvals for next-generation sequencing testing in the U.S.

What is FoundationOne CDx?

FoundationOne CDx is a tissue-based test used to detect genetic alterations to guide personalized cancer treatment.

How does FoundationOne CDx benefit oncologists?

It helps oncologists identify appropriate patients for targeted therapies like repotrectinib.

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