Clovis Oncology Announces Size of Initial hENT1-Low Population in Pivotal LEAP Trial and Provides Financial Guidance for 2

  • 65 percent of the initial 250 patients enrolled in the study are hENT1-low
  • Percentage consistent with retrospective analyses Clovis performed from other pancreatic cancer studies
  • Company expects $67 - $72 million cash burn for 2012

BOULDER, Colo.--(BUSINESS WIRE)-- Clovis Oncology, Inc. (NASDAQ: CLVS) announced today that the Independent Data Monitoring Committee (IDMC) for its pivotal trial of CO-101 in metastatic pancreatic cancer, LEAP (Low hENT1 and Adenocarcinoma of the Pancreas), has informed the Company that approximately 65 percent of the patients enrolled in LEAP have been classified as hENT1-low. This analysis is based on patients enrolled in the study through late October 2011, representing over two-thirds of the planned 360 patients expected to be enrolled in the study. The hENT1-low patients are the target population for CO-101, the Company’s lipid-conjugated gemcitabine. 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. The Company expects to complete enrollment in LEAP at the end of the first quarter 2012.

“It is very encouraging that initial information from LEAP has confirmed all of the retrospective work we conducted to develop an assay and predict the percentage of hENT1-low pancreatic cancer patients. It also affirms the robustness of LEAP, since we clearly now have a sufficiently large patient population and thus sufficient power to test our primary hypothesis,” said Patrick J. Mahaffy, President and CEO of Clovis Oncology.

The hENT1 Hypothesis

The standard first-line treatment for patients with metastatic pancreatic cancer is gemcitabine, given either as monotherapy or in combination with other cytotoxic agents. For gemcitabine to kill cancer cells, it must enter through specific membrane transporters on the surface of the cells, and human Equilibrative Nucleoside Transporter 1 (hENT1) has been shown to be the dominant transporter for gemcitabine. Tumor cells with low hENT1 expression have been shown to be resistant to gemcitabine therapy in vitro and in vivo, and retrospective analyses from multiple published studies of gemcitabine in pancreatic cancer have shown a strong correlation of overall survival outcomes to hENT1 expression, with patients that have low hENT1 expression receiving effectively no benefit from gemcitabine therapy. LEAP is the first trial that seeks to prospectively demonstrate this correlation.

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, all of which demonstrated that the percentage of hENT1-low patients was approximately two-thirds. This percentage has now been prospectively confirmed in LEAP. 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 CO-101

CO-101 (also known as CP-4126) is a novel, patented, lipid-conjugated form of the anti-cancer drug gemcitabine. In contrast to gemcitabine alone, CO-101 was designed to enter cancer cells regardless of hENT1 expression. CO-101 is intended to address the unmet need of patients with pancreatic cancer whose tumors express low amounts of hENT1 and therefore, are expected to be resistant to standard gemcitabine therapy.

About LEAP

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, although Clovis will be blinded to each patient’s hENT1 status until the end of the study when the primary analysis is completed. The study is designed to show that CO-101 has superior efficacy to gemcitabine in hENT1-low patients, in whom gemcitabine is believed to be minimally active.

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 (9th 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.

2012 Financial Guidance

The Company also provided financial guidance for 2012, stating that it expects a cash burn of $67 to $72 million for 2012, ending the year with approximately $70 million in cash which should allow the Company not only to complete the LEAP study but also demonstrate proof of concept for the Company’s other two programs under development. The planned cash burn for 2012 includes $4 million for an anticipated milestone payment associated with the Company’s CO-1686 development program.

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.



CONTACT:

Clovis Oncology, Inc.
Anna Sussman, 720-412-1159
[email protected]
or
Breanna Burkart, 720-412-4146
[email protected]

KEYWORDS:   United States  North America  Colorado

INDUSTRY KEYWORDS:   Health  Biotechnology  Clinical Trials  Genetics  Oncology  Pharmaceutical

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