Clovis Oncology, Inc. (Nasdaq: CLVS) announced today that it has reached
the target enrollment in its pivotal LEAP (Low hENT1 and Adenocarcinoma
of the Pancreas) study of CO-101 in metastatic pancreatic cancer. CO-101
is the Company's lipid-conjugated form of the anti-cancer drug
gemcitabine.
LEAP is an international, randomized, controlled 360-patient, pivotal
trial designed to demonstrate that CO-101 improves overall survival
versus gemcitabine in hENT1-low metastatic pancreatic cancer patients.
LEAP is the first study to utilize a companion diagnostic in metastatic
pancreatic cancer, and enrollment required collection of metastasis
biopsies prior to randomization, necessary to allow comprehensive
assessment of tumor hENT1 expression as a modifier of treatment outcome.
The study is being conducted at 99 centers in 15 countries. Top-line
overall survival data from LEAP are expected in the fourth quarter of
2012. If the trial is successful, Clovis intends to file for approval in
the US and EU by mid 2013. CO-101 has an orphan drug designation in the
United States and European Union for the treatment of pancreatic cancer.
"This is the first registration study that attempts to bring
personalized medicine to patients with pancreatic cancer, and our team
and our investigators did a superb job in completing enrollment in only
19 months," said Patrick J. Mahaffy, President and CEO of Clovis
Oncology. "If successful, this trial has the potential to be
practice-changing in the management and treatment of metastatic
pancreatic cancer, a disease for which only limited options are
available today."
Study validates deep learning model for predicting future lung cancer risk in Black population