Foundation Medicine’s Novel Companion Diagnostic Test, Developed in Collaboration with Clovis Oncology, Identifies Expanded Subgroup of Cancer Patients with the Potential to Respond to Clovis Oncology’s PARP inhibitor, Rucaparib

Interim Phase 2 Data Presented at EORTC-NCI-AACR Symposium

CAMBRIDGE, Mass. & BARCELONA, Spain--()--Foundation Medicine, Inc. (NASDAQ: FMI) today announced the presentation of new data from its ongoing collaboration with Clovis Oncology (NASDAQ: CLVS) to develop a novel companion diagnostic test to identify patients who have the potential to benefit from rucaparib, Clovis Oncology's poly (ADP-ribose) polymerase inhibitor (PARPi). These new data suggest that Foundation Medicine’s novel companion diagnostic can identify both BRCA-mutant patients and non BRCA-mutant patients who are more likely to benefit from rucaparib than patients who are biomarker negative.

The interim findings, being presented today in an oral plenary session at the 26th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics in Barcelona, are the first reported clinical data from ARIEL2 (Assessment of Rucaparib In Ovarian Cancer Trial), a single-arm, open-label Phase 2 study currently enrolling patients with relapsed, platinum-sensitive ovarian cancer. The study demonstrated an overall response rate of 70% in BRCA-mutant patients; these responses were observed in both germline and somatic BRCA-mutant tumors. Notably, 40% of patients identified by Foundation Medicine’s companion diagnostic as not BRCA-mutant, but with a “BRCAness” signature demonstrated a response to rucaparib, versus only 8% of patients without the signature, suggesting a potentially expanded group of patients who may benefit from rucaparib therapy.

Rucaparib has previously demonstrated activity in ovarian cancer patients with germline BRCA1/2 mutations; however, predicting response to a PARPi beyond tumors harboring germline BRCA1/2 mutations is a key challenge. Clovis Oncology and Foundation Medicine have partnered to develop a comprehensive genomic profiling-based assay to identify patients with BRCA1/2 mutations in tumor tissue, as well as those with a “BRCAness” signature, a tumor demonstrating homologous recombination deficiency (HRD) due to mechanisms other than a BRCA1/2 mutation. The test, which will be submitted for FDA premarket approval, assesses all classes of genomic alterations, and utilizes advanced bioinformatics based on Foundation Medicine's molecular information platform, to identify women with ovarian cancer who are more likely to respond to rucaparib.

The American Cancer Society estimates that in 2014 alone, about 21,980 new cases of ovarian cancer will be diagnosed, and 14,270 women will die of ovarian cancer in the United States, making it the fifth leading cause of cancer-related death among women.

“We are pleased to share these positive findings from our collaboration with Foundation Medicine demonstrating initial clinical utility of their companion diagnostic test in identifying the patients most likely to benefit from rucaparib,” said Andrew R. Allen, Ph.D., executive vice president of clinical and pre-clinical development and chief medical officer, Clovis Oncology. “A large percentage of patients identified as likely rucaparib responders had BRCAness tumors, which is especially compelling as these patients would not otherwise have been identified as candidates for rucaparib treatment based on screening with currently available BRCA diagnostics. An encouraging overall response rate was observed in this patient population, and more than half of these patients are now continuing treatment with rucaparib. We look forward to sharing updated results from ARIEL2 in the first half of 2015."

“Using our comprehensive genomic profiling capabilities and novel tissue-based diagnostics, we are uniquely positioned to analyze ovarian tumors for alterations and signatures predicting sensitivity to rucaparib. These capabilities have potentially important implications in other tumor types, including breast, prostate, pancreatic and even some lung cancers,” said Vincent Miller, M.D., chief medical officer, Foundation Medicine. “In ARIEL2, we have identified an expanded, novel population of ovarian cancer patients who are more likely to respond to rucaparib. The initial findings from this study further illustrate the value of Foundation Medicine’s molecular information platform in supporting the clinical development of our partners’ investigational therapies and ultimately bringing new treatment options to patients.”

Key ARIEL2 Interim Data

Elizabeth Swisher, M.D., professor of obstetrics and gynecology and adjunct professor of medical genetics at the University of Washington School of Medicine, presented, “ARIEL2: A Phase 2 study to prospectively identify ovarian cancer patients likely to respond to rucaparib,” during an oral plenary session today. Key findings include:

  • Foundation Medicine’s novel companion diagnostic test can identify ovarian cancer patients who are likely to respond to rucaparib by assessing all relevant BRCA1/2 mutations and a BRCAness signature in tumor tissue samples
  • Overall response rate (ORR) of 70% in BRCA-mutant patients; responses observed in patients with both germline and somatic mutations
  • ORR of 40% in patients with BRCAness signature
  • ORR of only 8% in patients without BRCA1/2 mutation or BRCAness signature
  • Approximately 67% of patients treated to date exhibit BRCA-ness signature or BRCA-mutant status
  • Rucaparib is well-tolerated; no drug discontinuations due to treatment-related adverse events
  • Molecular tumor analysis may identify a broad selection of ovarian cancer patients who could benefit from rucaparib therapy

About Rucaparib

Rucaparib is an oral, potent inhibitor of PARP1 and PARP2 being developed for the treatment of platinum-sensitive ovarian cancer in patients with BRCA mutations (genes that are linked to breast and ovarian cancers) and other DNA repair deficiencies. Rucaparib is also being explored in patients with BRCA-mutant pancreatic cancer in the RUCAPANC study.

About Clovis Oncology

Clovis Oncology, Inc. is a biopharmaceutical company focused on acquiring, developing and commercializing innovative anti-cancer agents in the U.S., Europe and additional international markets. Clovis Oncology targets development programs at specific subsets of cancer populations, and simultaneously develops diagnostic tools that direct a compound in development to the population that is most likely to benefit from its use. Clovis Oncology is headquartered in Boulder, Colorado.

About Foundation Medicine

Foundation 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's clinical assays, FoundationOne for solid tumors and FoundationOne Heme for hematologic malignancies, sarcomas and certain pediatric cancers, provide a fully informative genomic profile to identify the molecular alterations in a patient's cancer and match them with relevant targeted therapies 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 (@FoundationATCG).

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

Cautionary Note Regarding Forward-Looking Statements

This 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 patients who may be likely responders to rucaparib; the ability of Foundation Medicine to develop a companion diagnostic test able to identify BRCA-mutant patients and non BRCA-mutant patients; the clinical utility of the companion diagnostic test in identifying patients likely to benefit from rucaparib; and the value of Foundation Medicine’s molecular information platform in supporting the clinical development of investigational therapies. 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 risks that the companion diagnostic development is not completed; rucaparib or its companion diagnostic does not receive regulatory approval; 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, 2013, which is on file with the Securities and Exchange Commission, as well as other risks detailed in subsequent filings with the Securities and Exchange Commission, may be realized. 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.

Contacts

Media Contact:
Pure Communications, Inc.
Dan Budwick, 973-271-6085
dan@purecommunicationsinc.com
or
Investor Contact:
Khaled Habayeb, 617-418-2283
ir@foundationmedicine.com

Contacts

Media Contact:
Pure Communications, Inc.
Dan Budwick, 973-271-6085
dan@purecommunicationsinc.com
or
Investor Contact:
Khaled Habayeb, 617-418-2283
ir@foundationmedicine.com