On June 4, 2021 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 Company presented data from a phase I pharmacokinetic study of oral docetaxel plus encequidar ("oral docetaxel") and updated data from the phase III study of oral paclitaxel plus encequidar ("oral paclitaxel") illustrating tumor responses by molecular subtype (Press release, Athenex, JUN 4, 2021, View Source [SID1234583535]). The data are being presented in two posters at the American Society for Clinical Oncology 2021 (ASCO2021) Virtual Scientific Program, being held from June 4th to June 8th, 2021.

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An open label, pharmacokinetic study to determine the bioavailability, safety and tolerability of single dose oral docetaxel (Oradoxel) in metastatic prostate cancer mPC patients treated with IV docetaxel
Abstract 5050; Poster session: Genitourinary Cancer – Prostate, Testicular, and Penile

Data were presented from the open-label, two-way crossover phase I pharmacokinetic study of oral docetaxel vs IV docetaxel, which demonstrated the drug was well tolerated with no dose limiting toxicities, or drug-related serious adverse events. The mean absolute bioavailability was 15.9% (range 8% to 25%) with PK exposure becoming non-linear at 300 mg/m2. Based on these results and the results of other related studies, oral docetaxel 300 mg/m2 as divided doses is being further evaluated.

Confirmed Tumor Response by Molecular Subtype in Patients with Metastatic Breast Cancer (MBC): Sub analysis From a Phase 3 Clinical Study Comparing Oral Paclitaxel and Encequidar to IV Paclitaxel
Abstract 1073; Poster session: Breast Cancer – Metastatic

Updated data were presented from the phase III trial of oral paclitaxel, specifically tumor response rates by receptor subtype. Athenex presented the results of a post-hoc subgroup efficacy analysis based on additional tumor subtype data. Overall response rate in the intent-to-treat (ITT) population demonstrated that oral paclitaxel was superior to IV paclitaxel with confirmed response rates of 35.8% versus 23.4%, respectively (p=0.0107). Response based on tumor subtypes is listed in the table below.