Clavis Pharma ASA reports that Clovis Oncology, its partner for CP-4126 (also known as CO-101), has been informed by the Independent Data Monitoring Committee that 64% of the 360 patients enrolled into the pivotal LEAP study were classified as hENT1-low.
The hENT1-low patients comprise the target population in which the primary survival endpoint of the LEAP trial, which is evaluating CP-4126 in metastatic pancreatic cancer patients, will be assessed.
The final hENT1 classification is in line with the previously reported results, announced in January 2012, and those from retrospective analyses (the 002 study) of hENT1 expression in pancreatic cancer tissues, that approximately two thirds of metastatic pancreatic patients are likely to be hENT1-low.
Studies have shown that hENT1-low patients derive little or no benefit from standard gemcitabine therapy (refs 1-4).
The final size of the hENT1-low population among the 360 patients in the fully enrolled LEAP study also confirms that the trial is well-powered.
Top-line results from the trial are expected to be announced in the fourth quarter of 2012, and if positive, regulatory filings are anticipated in the US and Europe in mid-2013.
Olav Hellebø, Clavis Pharma CEO, said: "The size of the hENT1-low population for the primary endpoint analysis in the LEAP study confirms our belief that there is a significant proportion of pancreatic cancer patients who are not likely to benefit from standard gemcitabine therapy and that CP-4126 could provide a new treatment option for these patients. We look forward to results of the LEAP study later in 2012 with great anticipation.”