Clavis Pharma announces negative outcome of pivotal LEAP Trial with CP-4126 in Patients with Metastatic Pancreatic Cancer

19-Nov-2012 - Norway

Clavis Pharma ASA announced results of the LEAP (Low hENT1 and adenocarcinoma of the Pancreas) study of CP-4126 (also known as CO-101), versus gemcitabine in metastatic pancreatic cancer. The trial, which was conducted by partner Clovis Oncology, Inc., showed that there was no difference in overall survival between the two arms in either the primary analysis of the hENT1-low patient population, or in the overall intent-to-treat population. Median survival in each arm was approximately six months with a hazard ratio of 0.99, and is consistent with the survival results from other gemcitabine studies in metastatic pancreatic cancer.  Adverse events were comparable between the two arms, and no differences were observed in any subgroup analyses.

Contrary to the results of numerous published retrospective studies, the study demonstrated that hENT1 status had no impact on survival for patients with metastatic pancreatic cancer treated with gemcitabine. All development work with CP-4126 across all indications is now suspended by both Clavis Pharma and Clovis Oncology.

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