On January 16, 2018 Athenex, Inc. (Nasdaq:ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, reported that the United States Food and Drug Administration ("FDA") has provided positive feedback on the design of the currently ongoing Phase III Clinical Trial for Oraxol, an innovative oral formulation of paclitaxel combined with HM30181A (a novel P-gp inhibitor) (Press release, Athenex, JAN 16, 2018, View Source;p=RssLanding&cat=news&id=2326701 [SID1234523137]). Specifically, the FDA indicated that if the study meets the primary endpoint with an acceptable Benefit/Risk profile, it could be adequate as a single comparative trial to support registration of Oraxol for a metastatic breast cancer indication in the United States.
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The Oraxol Phase III clinical study (KX-ORAX-001) is a randomized controlled international clinical trial investigating the superiority of Oraxol over intravenous ("IV") paclitaxel in the treatment of patients with metastatic breast cancer. The primary endpoint is confirmed tumor response rate assessed by a blinded independent radiologic imaging analysis center using the RECIST Criteria, a generally accepted clinical response criteria for efficacy in tumor reduction. The study has a target sample size of 360 patients. The study has completed the first of two planned interim analyses. The second interim analysis based on 180 evaluable patients is planned for the middle of 2018. The positive US FDA feedback would allow an Oraxol US registration submission upon successful completion of this single Phase III study.
Dr. Rudolf Kwan, Athenex’s Chief Medical Officer, commented, "This positive feedback from the U.S. FDA is an important step in bringing Oraxol closer to the doctors and patients. Our Phase III trial also recently received the unanimous recommendation to continue by an independent Data and Safety Monitoring Board. The recommendation was based on the positive overall response rate of Oraxol and the very low incidence of neuropathy, which is a severe dose-limiting side-effect of IV paclitaxel."
Dr. Johnson Lau, Athenex’s Chief Executive Officer, added, "We are delighted with the positive feedback from the FDA on the Phase III Clinical Study Design for Oraxol, which provides further validation of our regulatory pathway for Oraxol. With the recent allowance of the Oraxol Investigational New Drug application in China and the receipt of the Promising Innovative Medicine designation from the United Kingdom Medicines and Healthcare products Regulatory Agency, we continue to advance towards our goal of improving the lives of cancer patients worldwide."
Athenex previously announced that the Data and Safety Monitoring Board unanimously recommended the continuation of its Phase III clinical trial comparing Oraxol versus IV paclitaxel in the treatment of metastatic breast cancer after the interim analysis of the first 90 patients on October 5, 2017. Additionally, the Company announced the receipt of the Promising Innovative Medicine designation for Oraxol by the United Kingdom Medicines and Healthcare products Regulatory Agency on December 27, 2017, qualifying Athenex to apply for Step II of the Early Access to Medicines Scheme to provide patients early access to Oraxol prior to receiving marketing authorization. Athenex also recently announced that the Chinese FDA has allowed the Investigational New Drug application for Oraxol on January 8, 2018, enabling Athenex to initiate clinical studies in China.