CP-4126: Development discontinued

Clavis and partner Clovis discontinued development of CP-4126 after data from the open-label, international, pivotal Phase II LEAP trial in 367 patients with metastatic pancreatic cancer showed that IV CP-4126 missed the primary endpoint of improving OS in patients with low levels of ENT1 expression vs. gemcitabine. The partners also said there was no difference in OS between treatment arms in the overall population. Median OS was about 6 months in each arm in the overall population (HR=0.99). Adverse events were comparable between treatment arms. CP-4126 was also in a Phase I trial to treat non-small cell lung cancer (NSCLC). Further analysis of the LEAP data will be conducted, but Clavis said it expects Clovis to return rights to the compound. In 2010, Clavis expanded a 2009 deal to give Clovis exclusive, worldwide rights to CP-4126. Under the original deal, Clovis had rights to the product in the U.S., Europe, Canada, and Central and South America (see BioCentury, Nov. 15, 2010). CP-4126 has Orphan Drug designation in the U.S. and Europe for pancreatic cancer.

Clavis said it will continue to focus on development of elacytarabine, a Lipid Vector Technology (LVT) derivative of cytarabine (Ara-C) in the Phase III CLAVELA trial to treat acute myeloid leukemia (AML) in patients who have failed prior therapy. Top-line data from CLAVELA are expected in 1Q13. ...