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OxOnc Development LP,
(OxOnc), today announced that it has entered into a co-development agreement
with Pfizer Inc., to conduct a pivotal clinical trial of Pfizer's
PFE crizotinib,
marketed under the trademark Xalkori®, for the treatment of patients with
advanced non-small cell lung cancer (NSCLC) harboring a ROS1 (c-ros) gene
rearrangement (ROS1-positive). ROS1 is a receptor tyrosine kinase of the
insulin receptor family.
The trial will be conducted at multiple sites in Japan, China, Taiwan and
South Korea to assess the safety and efficacy of crizotinib in patients with
ROS1-positive advanced NSCLC. Crizotinib is approved for the treatment of
patients with ALK-positive advanced NSCLC in the U.S., EU^1, Japan and other
countries.
Under the terms of the agreement, OxOnc will provide funding and supervision
for the trial, with the goal of generating the clinical data necessary for
Pfizer to submit crizotinib for review by regulatory authorities for the
treatment of advanced ROS1-positive NSCLC in the Asian region. If approved for
this indication, OxOnc will be eligible to receive milestone payments from
Pfizer. Additional terms were not disclosed.
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