CAYMAN ISLANDS, June 02, 2017 (GLOBE NEWSWIRE) — OxOnc Development LP (OxOnc) today announced that co-development partner, Pfizer, Inc., has received regulatory approval in both Japan and Taiwan to market crizotinib (Xalkori®) 200 mg/250 mg capsules for the treatment of patients with ROS1-positive advanced non-small cell lung cancer (NSCLC). ROS1 is a receptor tyrosine kinase of the insulin receptor family.
Pursuant to terms of the co-development agreement with Pfizer, OxOnc was the sponsor of study OO-1201 (the “Study”), a Phase 2 open-label, multi-center, single-arm study of crizotinib in 127 East Asian patients with ROS-1 positive metastatic NSCLC. The Study was the largest ROS1-positive NSCLC cohort reported and was conducted in the People’s Republic of China (PRC), Japan, Taiwan and South Korea. As announced in June 2016, the Study met its primary objective of demonstrating a high objective response rate. OxOnc is entitled to certain milestone payments from Pfizer subject to successful regulatory approvals in selected countries. Terms were not disclosed.
The Study results showed that ROS1-positive NSCLC patients treated with crizotinib had an objective response rate of 69% (95% CI: 61,77) as determined by an independent radiology review. Further, the safety profile of crizotinib in these patients was consistent with the known overall safety profile for the drug.
Wenn Sun, Ph.D., managing partner of OxOnc, stated, “The approval for Xalkori for patients with ROS1-positive NSCLC in Japan and Taiwan is an exciting achievement and provides immediate access to biomarker-driven therapy for patients suffering from this rare form of cancer. We are honored to have partnered with Pfizer on the development of Xalkori for this indication and offer our congratulations to all parties involved in the effort.”
Xalkori is a receptor tyrosine kinase inhibitor developed and commercialized by Pfizer Inc., and is approved in the United States, European Union, Japan and Taiwan for the treatment of ALK-positive and ROS1-positive advanced non-small cell lung cancer.
OxOnc Development LP is an oncology development company founded by pharmaceutical executives and oncology experts who previously held leadership positions at GSK, Sanofi and Quintiles, and has been funded by OrbiMed Advisors, a leading venture capital group in life sciences.
CONTACT: For additional information: Wenn Sun, Ph.D. OxOnc Development LP T: 609.228.5757 ext: 102 F: 609.935.0918 Email: Info@oxfordoncology.com