FMI Foundation Medicine, Inc. (delisted)

Foundation Medicine, Inc. (NASDAQ:FMI) today announced that new data generated from its comprehensive genomic profiling (CGP) assays will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting from June 1-5, 2018 in Chicago. The company and its collaborators will present a total of 28 studies, including two oral presentations. Highlights of these presentations include:

• studies demonstrating the importance of known and novel genomic biomarkers of immunotherapy response, including tumor mutational burden (TMB), microsatellite instability (MSI) and PBRM1 alterations across a diverse range of cancer types that could inform more precise use of these treatments;
• new data from PURE-01, a phase II study evaluating neo-adjuvant pembrolizumab in urothelial bladder cancer demonstrates the ability of CGP to detect genomic biomarkers (RB1, PBRM1 and TMB) when combined with T-cell inflammation signatures to potentially predict response to immunotherapy;
• new data showing that high tissue TMB is associated with higher likelihood of response and longer duration of response to atezolizumab in non-small cell lung cancer, metastatic urothelial carcinoma and melanoma;
• data from FoundationACT® liquid biopsy assay, describing the landscape of kinase fusions and rearrangements from ctDNA in more than 9,000 clinical cases across multiple cancer types; and
• updated data from the precision oncology I-PREDICT clinical trial showing improvements in patient outcomes with integration of molecular tumor boards informed by CGP into treatment planning.

These studies further underscore the importance of Foundation Medicine’s portfolio of CGP assays and molecular data services in supporting precision treatment approaches using tissue or blood samples.

“The role of comprehensive genomic profiling in cancer treatment is evolving very quickly, particularly in predicting who will respond best to new treatments, such as immunotherapy. Foundation Medicine has led essential discoveries in advancing TMB and other genomic biomarkers of immunotherapy response that will help shape the treatment landscape and advance our understanding of how best to use personalized immunotherapy treatment in clinical care,” said Vincent Miller, M.D., chief medical officer at Foundation Medicine. “Our studies presented at ASCO underscore our patient-centric approach using CGP to further refine the clinical utility of existing biomarkers while discovering new ones that can help better inform precision treatments across a broad range of cancer types with the ultimate goal of improving patient care.”

Comprehensive genomic profiling is helping to uncover the predictive power of TMB and other pathogenic biomarkers in different types of cancer. In data to be presented in an oral session, biomarker analysis by CGP in metastatic urothelial carcinoma has the potential to identify patients who could benefit from a bladder sparing approach through the opportunity to respond to immune checkpoint inhibitors.

“The near 40% frequency of complete pathologic response to the neoadjuvant pembrolizumab regimen in this bladder muscle invasive urothelial carcinoma trial is unprecedented. These results substantially improved by selecting patients harboring molecular alterations, regardless of PD-L1 expression,” said Andrea Necchi, M.D., department of medical oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy. “Our data indicate that biomarker-based patient selection using the comprehensive genomic profiling and gene expression profiling has the potential to identify patients destined to achieve complete tumor eradication and raises the possibility that this sub-group of patients could be managed in the future without radical cystectomy.”

In another oral presentation, a pooled analysis of seven clinical studies of the anti-PD-L1 immunotherapy agent atezolizumab found that high TMB was associated with improved response and duration of response in non-small cell lung cancer, metastatic urothelial carcinoma and melanoma. Additionally, in a separate presentation, investigators from the Moffitt Cancer Center worked with Foundation Medicine scientists utilizing CGP to show that within a group of 57 advanced Merkel cell carcinoma (MCC) patients, nearly all had either high TMB or evidence of the Merkel cell polyomavirus as measured by viral content detection. Patients with neither marker were unlikely to respond to immunotherapy, which may help guide use of this treatment in MCC in which high response rates to immunotherapy have been observed but predictive factors of response have not been well elucidated.

New studies also characterize the landscape of PBRM1 alterations, a new potential biomarker of immunotherapy response. Recent evidence suggests that PBRM1 alterations are associated with clinical benefit from checkpoint inhibitor immunotherapy in clear cell renal carcinoma (ccRCC), an immunotherapy-responsive tumor type which characteristically lack high MSI or TMB. In a new study presented at ASCO, CGP was performed on more than 140,000 solid tumors and hematologic malignancies and found that PBRM1 alterations were highly enriched in ccRCC (45 percent) compared with other tumor types (2.6 percent). Another study of mesothelioma found that PBRM1 alterations were present in 11 percent of samples, suggesting that immunotherapy may also serve as an important treatment option in this cancer type.

Because a tissue sample may not be readily available for some cancer patients, especially those with advanced disease, liquid biopsy is becoming an increasingly important option to help inform personalized treatment approaches. In new data presented, FoundationACT was used to help describe the pan-cancer landscape of kinase rearrangements, which are established therapeutic targets. Analysis of circulating tumor DNA (ctDNA) from blood samples of nearly 9,000 clinical cases showed that kinase fusions and rearrangements exist across tumor types and can be detected using FoundationACT, which may help inform both treatment decisions and clinical development.

Following is a list of abstracts that will be presented at the meeting.

Abstract #     Title     Day/Time     Location

Immunotherapy/TMB Data

4507 (Oral Presentation) Preoperative pembrolizumab (pembro) before radical cystectomy (RC) for muscle-invasive urothelial bladder carcinoma (MIUC): Interim clinical and biomarker findings from the phase 2 PURE-01 study. June 3, 10:12am-10:25am Arie Crown Theater 12000 (Oral Presentation) Association of high tissue TMB and atezolizumab efficacy across multiple tumor types June 5, 8:00am-8:12am Room S406 11553 Primary pulmonary sarcomas (PSRC): A comprehensive genomic profiling (CGP) study June 2, 8:00am-11:30am Hall A 11576 Genomic subtypes of angiosarcoma: a comprehensive genomic profiling (CGP) study June 2, 8:00am-11:30am Hall A 4547 APACHE: An open label, randomized, phase 2 study of Durvalumab (Durva), alone or in combination with Tremelimumab (Treme), in patients (pts) with advanced germ cell tumors (GCT): results at the end of first stage June 2, 8:00am-11:30am Hall A 4531 FGFR3 driven metastatic urothelial carcinoma of the urinary bladder (mUCB): A comprehensive genomic profiling study June 2, 8:00am-11:30am Hall A 4595 PECULIAR: An open label, multicenter, single-arm, phase 2 study of neoadjuvant pembrolizumab (PEM) and epacadostat (EPA), preceding radical cystectomy (Cy), for patients (pts) with muscle-invasive urothelial bladder cancer (MIUBC). June 2, 8:00am-11:30am Hall A 4536 Prognostic values of genetic alterations of DNA repair genes in advanced bladder cancer. June 2, 8:00am-11:30am Hall A 11579 Frequency of genomic biomarkers of response to immunotherapy in sarcoma June 2, 8:00am-11:30am Hall A 3574 MSI-high and MSI-stable colorectal carcinomas (CRC): A comprehensive genomic profiling (CGP) Study June 3, 8:00am-11:30am Hall A 8562 PBRM1 genomic alterations in mesothelioma: potential predictor of immunotherapy efficacy June 3, 8:00am-11:30am Hall A 12091 PBRM1 mutation and immunotherapy efficacy: A comprehensive genomic profiling (CGP) assessment June 4, 1:15pm-4:45pm Hall A 12092 PD-L1 genomic alterations (GA) in solid tumors and hematologic malignancies: A comprehensive genomic profiling (CGP) study June 4, 1:15pm-4:45pm Hall A 9587 Comprehensive genomic profiling of metastatic cutaneous adnexal carcinomas to reveal multiple routes to targeted and immunotherapies June 4, 1:15pm-4:45pm Hall A

Targeted Therapy Data

5521 (Poster Discussion) Genomic mutation profiles of paired ovarian cancers (OC) across time June 4, 4:45pm-6:00pm Room S100bc 1074 Efficacy of olaparib monotherapy in patients (pts) with HER2-negative metastatic breast cancer (MBC) with germline BRCA mutation (gBRCAm) or lesional BRCA mutation (lBRCAm) June 2, 8:00am-11:30am Hall A 4555 Comprehensive genomic characterization of chemotherapy-resistant testicular germ cell tumors (TGCT) June 2, 8:00am-11:30am Hall A 6089 Comprehensive genomic profiling of anaplastic thyroid carcinoma June 2, 1:15pm-4:45pm Hall A 2039 Comprehensive genomic profiling of brain tumors provides targeted therapy options and diagnostic certainty for oligodendrogliomas June 2, 1:15pm-4:45pm Hall A 4063 Co-existing alterations in cell-cycle pathway genes and impact on benefit from trastuzumab in advanced esophagogastric cancers (EGC): Analysis of 527 Her2-amplified cases June 3, 8:00am-11:30am Hall A 9035 Multi-kinase RET inhibitor vandetanib combined with mTOR inhibitor everolimus in patients with RET rearranged non-small cell lung cancer June 3, 8:00am-11:30am Hall A 2531 Investigation of Profile-Related Evidence Determining Individualized Cancer Therapy (I-PREDICT) in heavily pre-treated patients: A role for combinatorial precision cancer therapy June 4, 8:00am-11:30am Hall A 12083 Clinicopathologic characteristics and molecular features of BRG1-deficient non-small cell lung cancer (NSCLC) June 4, 1:15pm-4:45pm Hall A 5590 Assessment of activating estrogen receptor 1 (ESR1) mutations in gynecologic malignancies June 4, 1:15-4:45pm Hall A

Liquid Biopsy Data

9040 Characterization of 1,233 NSCLCs with non-del19/L858R EGFR mutations (EGFRm) using comprehensive genomic profiling (CGP) June 3, 8:00am-11:30am Hall A 12041 Landscape of kinase rearrangements (kRE) detected in circulating tumor DNA (ctDNA) June 4, 1:15pm-4:45pm Hall A

About Foundation MedicineFoundation Medicine (NASDAQ:FMI) 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 http://www.FoundationMedicine.com or follow Foundation Medicine on Twitter (@FoundationATCG).

Cautionary Note Regarding Forward-Looking Statements for Foundation MedicineThis press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the value and impact of CGP, including Foundation Medicine’s suite of CGP assays, and molecular information from CGP; the ability of TMB, MSI, PBRM1, or any other biomarkers to predict response to immunotherapy; and the ability of research and discovery of biomarkers to improve access to personalized cancer treatment. All such forward-looking statements are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include the risk that the results presented are found to lack scientific, medical or clinical utility or that subsequent research renders the results presented less useful or not useful in clinical practice; Foundation Medicine's assays and molecular information platform will not be able to identify genomic alterations in the same manner as prior clinical data; and the risks described under the caption "Risk Factors" in Foundation Medicine's Annual Report on Form 10-K for the year ended December 31, 2017, which is on file with the Securities and Exchange Commission, as well as other risks detailed in Foundation Medicine's subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Foundation Medicine undertakes no duty to update this information unless required by law.

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

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Foundation MedicineMedia:Lee-Ann Murphy, 617-245-3077pr@foundationmedicine.comorInvestors:Kimberly Brown, 617-418-2215ir@foundationmedicine.com