Clovis Oncology, a biopharmaceutical company, has announced the results from its LEAP (Low hENT1 and Adenocarcinoma of the Pancreas) study of CO-101 versus gemcitabine in metastatic pancreatic cancer.
The study was based on previous research suggesting that patients with low levels of a protein, which is involved in moving molecules including some drugs into cells, called tumour cell hENT1 (human equilibrative nucleoside transporter-1), benefit less from gemcitabine than patients with high levels.
The trial was testing the theory that pancreatic tumours expressing low levels of hENT1 will respond better to CO-101 (a derivative of gemcitabine called gemcitabine elaidate) than to gemcitabine because this new drug does not depend on hENT1 to enter the tumour cells.
Unfortunately, there was no difference in overall survival between the two arms of study 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, and is entirely consistent with the survival results from other gemcitabine studies in metastatic pancreatic cancer. Toxicities were comparable between the two arms, and no differences were observed in any subgroup analyses.
The study also demonstrated that, hENT1 status had no impact on survival for patients on gemcitabine, contrary to the results of numerous published retrospective studies.
As a consequence of these results, Clovis will suspend all development of CO-101, pending further evaluation of the LEAP data.
Alex Ford, CEO, Pancreatic Cancer UK comments, "We had been very hopeful that this study would be successful and provide improved treatment for patients with advanced pancreatic cancer. Whilst we commend Clovis for undertaking it, we are naturally very disappointed by the results. They show no benefit to patients and do not help us to further understand which patients will benefit from gemcitabine.
"This emphasises even more the urgent need for further research into pancreatic cancer; which we are calling for as part of our Raise for Research campaign this November."
Source: Clovis Oncology press release