On February 15, 2018 Athenex (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 enrollment of patients is on target for the Company to be able to conduct a second interim analysis in the Oraxol KX-ORAX-001 Phase III clinical trial in the third quarter of 2018 (Press release, Athenex, FEB 15, 2018, View Source;p=RssLanding&cat=news&id=2332730 [SID1234523998]).
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Oraxol, an innovative development in the treatment of cancer, is a novel oral formulation of paclitaxel, a very effective and commonly used chemotherapy treatment for many cancers, combined with HM30181A (a novel orally non-absorbable gastrointestinal tract P-glycoprotein pump inhibitor). The Oraxol KX-ORAX-001 Phase III clinical trial is an international randomized controlled clinical trial comparing Oraxol monotherapy against intravenous (IV) paclitaxel monotherapy in patients with metastatic breast cancer, with target sample size of 360 patients. The study is designed to show superiority of clinical efficacy of Oraxol over IV paclitaxel based on independently confirmed response rates.
In accordance with the protocol the Company conducted a first interim analysis when 90 patients completed 18 weeks of treatment in October 2017. Based on that analysis, the independent Drug Safety Monitoring Board (DSMB) unanimously recommended continuation of the study. The DSMB was impressed by the conduct of the study in achieving a good overall response rate. The DSMB noticed that neuropathy was rare with Oraxol treatment. Neuropathy is a dose limiting toxicity of IV paclitaxel. The DSMB encouraged the rapid patient recruitment toward the scheduled second interim analysis at 180 patients.
Athenex has already enrolled more than 180 patients and therefore expects the second interim analysis in the third quarter of 2018.
Dr. Rudolf Kwan, Chief Medical Officer, commented, "In January 2018, we had positive feedback from the FDA that if this 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. We are looking forward to seeing results from the second interim analysis of this clinical trial."
Dr. Johnson Lau, Athenex’s Chief Executive Officer and Chairman of the Board, stated, "We are very proud of the excellent planning and execution of our clinical team. To be able to deliver both the enrollment for the Oraxol Phase III study on target time and the enrollment of two Phase III studies for KX-01 Ointment for the treatment of actinic keratosis ahead of schedule reflect the hard work, quality and the commitment of our clinical operation team. We are delighted that we are going to again deliver an interim analysis of the topline Oraxol Phase III study results on schedule as planned. Athenex is also conducting clinical studies on Oraxol in other geographic areas as well as for the expansion of clinical indications. We are also proud that Oraxol has recently obtained the Promising Innovative Medicine (PIM) designation by the United Kingdom Health Authority MHRA and also the allowance of two IND (HM30181A and oral paclitaxel capsules) by the Chinese FDA."