Foundation Medicine, Inc. today announced a collaboration with Eli Lilly and Company (Lilly) for the development of Foundation Medicine’s tissue- and blood-based assays as companion diagnostics for RETEVMO® and other therapies in Loxo Oncology at Lilly’s pipeline. The partnership will initially explore the use of FoundationOne®CDx for adult patients with metastatic rearranged transfection (RET) fusion across tumor types who may be eligible for Lilly’s RET inhibitor, RETEVMO in the United States and 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, chief biopharma business officer at Foundation Medicine. “This broad partnership will tap into our portfolio of end to end solutions to generate meaningful evidence and help optimize Lilly’s therapy development, and ultimately bring more targeted treatment options to cancer patients.”

“We are pleased to collaborate with a widely-utilized and experienced laboratory like Foundation Medicine to ensure broad access to high quality, comprehensive genomic profiling for cancer patients who do not have access to such testing in their home institutions,” said Anthony (Nino) Sireci, M.D., Vice President, Clinical Biomarkers 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 therapy specifically indicated for the treatment of adult patients with metastatic 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 RET-mutant medullary thyroid cancer (MTC) who require systemic therapy, or advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). RET fusions have been identified in approximately 2% of non-small cell lunger cancer (NSCLC) patients, 10% to 20% of papillary thyroid cancer patients, 60% of sporadic medullary thyroid cancer patients, over 90% of hereditary medullary thyroid cancer patients, 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 across 8 targeted therapies.

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 www.F1CDxLabel.com.

About FoundationOne®Liquid CDx

FoundationOne Liquid CDx is a qualitative next generation sequencing based in vitro diagnostic test for prescription use only that uses targeted high throughput hybridization-based capture technology to analyze 324 genes utilizing circulating cell-free DNA (cfDNA) isolated from plasma derived from anti-coagulated peripheral whole blood of advanced cancer patients. The test is FDA-approved 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 the Intended Use) in accordance with the approved therapeutic product labeling. Additional genomic findings may be reported and are not prescriptive or conclusive for labeled use of any specific therapeutic product. 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. Patients who are negative for companion diagnostic mutations should be reflexed to tumor tissue testing and mutation status confirmed using an FDA-approved tumor tissue test, if feasible. For the complete label, including companion diagnostic indications and complete risk information, please visit www.F1LCDxLabel.com.

About Foundation Medicine

Foundation Medicine is a molecular information company dedicated to a transformation in cancer care in which 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 assays to identify the molecular alterations in a patient’s cancer and match them with relevant targeted therapies, immunotherapies and clinical trials. Foundation Medicine’s molecular information platform aims to improve day-to-day care for patients by serving the needs of clinicians, academic researchers and drug developers to help advance the science of molecular medicine in 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-driven cancers: lessons from 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 experience on RET genetic screening in hereditary MTC: an update on the prevalence of germline RET 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 high-recurrence risk papillary thyroid cancer. Cancer Res Treat. 2017;49(4):906-914. 9

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