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Clovis Oncology, Inc. (NASDAQ: CLVS) today announced the results from its LEAP (Low hENT1 and Adenocarcinoma of the Pancreas) study of CO-101 versus gemcitabine in metastatic pancreatic cancer. 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 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. Key prognostic variables, including performance status and age, were balanced between the hENT1-low and -high groups.
Importantly, the study also demonstrated that, contrary to the results of numerous published retrospective studies, hENT1 status had no impact on survival for patients on gemcitabine.
“We are obviously disappointed with these results, which are unambiguous,” said Patrick J. Mahaffy, president and CEO of Clovis Oncology. “We would like to thank the investigators, and mostly the patients, who participated in this trial and we wish the best for the developers of other agents to treat this devastating, very difficult to treat disease.”
As a consequence of these results, Clovis will suspend all development of CO-101, pending further evaluation of the LEAP data, and focus its resources on the three product candidates in its portfolio.
Clovis’ product pipeline includes: CO-1686, an orally-available, epidermal growth factor receptor (EGFR) covalent inhibitor, currently in a Phase I/II study for the treatment of non-small cell lung cancer (NSCLC) in patients with initial activating EGFR mutations as well as the T790M primary resistance mutation;
rucaparib, an orally-available, small molecule poly (ADP-ribose) polymerase (PARP) inhibitor being developed for certain ovarian and breast cancers that is currently in a Phase I/II clinical program both as monotherapy and in combination with chemotherapy; and, a novel
cKIT inhibitor targeting resistance mutations for the treatment of gastrointestinal stromal tumors (GIST), currently in the discovery phase.
For both CO-1686 and rucaparib, the Company currently anticipates presenting Phase I data at ASCO in June 2013. For CO-1686, Clovis expects to have evidence of efficacy data in the T790M population from the ongoing Phase I/II study in the second half of 2013, and, if data are positive, commence a registration study in the first half of 2014. Pending positive data from the rucaparib studies, the Company plans to initiate a global registration study in 2013 in platinum-sensitive ovarian cancer patients with deficiencies in BRCA and other DNA repair genes.