Foundation Medicine Announces Global Collaboration with Lilly to Develop FoundationOne®CDx and FoundationOne®Liquid CDx as Complementary Diagnostics for RETEVMO® and Loxo Oncology in Lilly’s Pipeline Programs

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Foundation Medicine, Inc. today announced a collaboration with Eli Lilly and Company (Lilly) to develop Foundation Medicine’s tissue and blood tests as companion diagnostics for RETEVMO® and other therapies in Loxo Oncology in Lilly’s pipeline. The partnership will initially explore the use of FoundationOne®CDx for adult patients with rearranged metastatic transfection (RET) fusion between tumor types that may be eligible for Lilly disease RET inhibitor, RETEVMO in the United States and the European Union.

“Foundation Medicine’s deep regulatory and genomics expertise makes us an essential partner for companies like Lilly who share our commitment to transforming cancer care,” said Sanket Agrawal, MPH, MBA, Director of biopharmaceutical affairs at Foundation Medicine. “This broad partnership will leverage our end-to-end portfolio of solutions to generate meaningful evidence and help optimize Lilly’s therapy development, and ultimately bring more targeted treatment options to cancer patients.

“We are delighted to collaborate with a widely used and experienced laboratory like Foundation Medicine to ensure broad access to comprehensive, high-quality genomic profiling for cancer patients who do not have access to such tests at their institutions. origin,” Anthony (Nino) said. Sireci, MD, Vice President, Clinical Biomarker and Diagnostics Development, Loxo Oncology at Lilly. “This global partnership offers this important patient population the opportunity to benefit from recent advances in precision oncology.”

RETEVMO was approved by the Food and Drug Administration (FDA) in May 2020 as the first treatment specifically indicated for the treatment of adult patients with metastases RET fusion-positive non-small cell lung cancer (NSCLC), and the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic cancer RET– mutant medullary thyroid cancer (MTC) requiring systemic treatment, or advanced or metastatic RET fusion-positive thyroid cancers that require systemic treatment and are refractory to radioactive iodine (if radioactive iodine is appropriate). RET fusions have been identified in approximately 2% of patients with non-small cell lung cancer (NSCLC), 10% to 20% of patients with papillary thyroid cancer, 60% of patients with sporadic medullary thyroid cancer, more than 90% of patients with hereditary medullary thyroid cancer. , and rarely in other cancers. I, ii, iii

Foundation Medicine has the most FDA-approved companion diagnostic claims on the market, across multiple cancer indications: FoundationOne CDx with 26 companion diagnostic claims and two group claims across 28 targeted therapies, and FoundationOne Liquid CDx with 9 companion diagnostic claims on 8 targeted therapies.

About FoundationOne®CDx

FoundationOne CDx is next-generation sequencing based on in vitro diagnostic device for the detection of substitutions, insertion and deletion alterations (indels) and copy number alterations (CNA) in 324 genes and rearrangements of selected genes, as well as genomic signatures, including the microsatellite instability (MSI) and tumor mutational load (TMB) using DNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue samples. 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 for use by qualified healthcare professionals in accordance with professional oncology guidelines for patients with solid malignant neoplasms. Use of the test does not guarantee that a patient will be matched to a treatment. A negative result does not exclude the presence of an alteration. Some patients may require a biopsy. For a complete list of targeted therapies for which FoundationOne CDx is indicated as a companion diagnostic, please visit www.F1CDxLabel.com.

About FoundationOne®Liquid CDx

FoundationOne Liquid CDx is a next-generation sequencing-based qualitative in vitro diagnostic test for prescription use only that uses high-throughput hybridization-based targeted capture technology to analyze 324 genes using cell-free DNA (cfDNA) isolated from plasma derived from peripherally anticoagulated whole blood of patients with advanced cancer. The test is FDA-cleared to report short variants in over 300 genes and is a companion diagnostic to identify patients who may benefit from treatment with specific therapies (listed in Table 1 of Intended Use) in accordance to the labeling of the approved therapeutic product. Additional genomic findings may be reported and are not prescriptive or conclusive for the labeled use of a specific therapeutic product. Use of the test does not guarantee that a patient will be matched to a treatment. A negative result does not exclude the presence of an alteration. Patients who are negative for associated diagnostic mutations should be referred for tumor tissue testing and mutation status confirmed using an FDA-cleared tumor tissue test, if possible. For the full label, including associated diagnostic indications and complete hazard information, please visit www.F1LCDxLabel.com.

About basic medicine

Foundation Medicine is a molecular information company dedicated to transforming cancer care where treatment is informed by a deep understanding of the genomic changes that contribute to each patient’s unique cancer. The company offers a full suite of comprehensive genomic profiling tests to identify molecular alterations in a patient’s cancer and link them to relevant targeted therapies, immunotherapies and clinical trials. Foundation Medicine’s Molecular Information Platform aims to improve everyday patient care by meeting the needs of clinicians, academic researchers and drug developers to help advance the science of molecular medicine in the treatment of cancer. For more information, please visit www.FoundationMedicine.com or follow Foundation Medicine on Twitter and LinkedIn.

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

Source: Foundation Medicine

I Drilon A, Hu ZI, Lai GGY, Tan DSW. Targeting RET-induced cancers: lessons from the evolving preclinical and clinical landscapes. Nat Rev Clin Oncol. 2018;15(3):150.

ii Elisei R, Tactio A, Ramone T, et al. Twenty-five years of experience in RET genetic screening in hereditary MTC: an update on the prevalence of RET germline mutations. Genes (Basel). 2019;10(9). doi:10.3390/genes10090698

iii Lee MY, Ku BM, Kim HS, et al. Genetic alterations and their clinical implications in papillary thyroid cancer at high risk of recurrence. Treating Cancer Res. 2017;49(4):906-914. 9

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