LEAP is an international, randomized, controlled 360-patient, pivotal trial designed to demonstrate that CO-101 improves overall survival versus gemcitabine in hENT1-low metastatic pancreatic cancer patients. Patients enrolled in the trial are being randomized on a one-to-one basis to receive either CO-101 or gemcitabine. Metastatic tumor tissue is collected from all patients to enable hENT1 assessment and patient classification, although investigators and Clovis are blinded to each patient’s hENT1 status until the end of the study. The hENT1-low patients are the target population for CO-101 and the subject of the primary overall survival analysis in LEAP. If the study meets the primary endpoint, the efficacy of CO-101 in other patient populations contained within the trial will be prospectively examined in statistical step-down fashion.
About the hENT1 Companion Diagnostic Test
Clovis has established a collaboration with Ventana Medical Systems, Inc. to develop an in vitro diagnostic (IVD) to reliably measure tissue hENT1 expression and enable prospective classification of patients as either hENT1-high or hENT1-low. Clovis utilized this IVD to establish the definition of hENT1-high and hENT1-low patients from a number of clinical studies of gemcitabine, which allowed outcome data to guide an optimized definition of “hENT1-low” that identifies patients who are expected to derive little benefit from gemcitabine therapy. These studies consistently demonstrated that the percentage of hENT1-low patients was approximately two-thirds. This percentage was prospectively confirmed in LEAP when Clovis announced in January 2012 that 65 percent of the initial 250 patients enrolled in the study were classified as hENT1-low. As part of the development plan for CO-101, Clovis and Ventana have completed the necessary analytical validation studies for the IVD, and it is currently undergoing clinical validation in LEAP. Ventana intends to submit the Pre-Market Approval Application, or PMA, in coordination with Clovis’ New Drug Application, or NDA, for CO-101.About Pancreatic Cancer According to the American Cancer Society, over 43,000 new cases of pancreatic cancer occurred in the United States in 2010. In addition, according to Pancreatic Cancer Action Network, over 60,000 new cases are reported each year in the European Union and according to a study published in Cancer Chemotherapy and Pharmacology in 2004, over 20,000 new cases are reported annually in Japan. According to Medical, Surgical & Radiation Oncology (9 th Edition, 2005), 85 percent of patients with pancreatic cancer present with unresectable, locally advanced, also referred to as Stage III, or metastatic, also referred to as Stage IV, disease. Even after surgical resection and adjuvant chemotherapy or radiotherapy for apparently localized disease, these patients often experience early recurrence and rapid disease progression. As a result, according to the American Cancer Society, pancreatic cancer has one of the highest mortality rates among all cancers, with estimates for one- and five-year overall survival of 24 and 5 percent, respectively, in the United States. 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, and has additional offices in San Francisco, California and Cambridge, UK.
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