On November 22, 2021 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 an abstract for a subgroup analysis of its Phase 3 study of oral paclitaxel and encequidar (Oral Paclitaxel) for the treatment of metastatic breast cancer has been accepted for poster presentation at the 2021 San Antonio Breast Cancer Symposium (SABCS), to be held from December 7 to December 10, 2021 (Press release, Athenex, NOV 22, 2021, View Source [SID1234595885]).
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The abstract and poster provide data from a post hoc, subgroup analysis of safety, progression free survival and overall survival of patients with elevated liver enzymes (AST or bilirubin) from study KX-ORAX-001, a Phase 3 study of weekly Oral Paclitaxel plus Encequidar vs IV Paclitaxel 175mg/m2 every three weeks. 402 subjects were randomized in a 2:1 ratio to Oral Paclitaxel and Encequidar vs IV Paclitaxel.
Prior to treatment, 122 patients out of 402 total study patients (30.3%) had elevated AST or bilirubin, primarily mild hepatic dysfunction. For patients with elevated liver enzymes receiving Oral Paclitaxel, the median survival was 18.9 months compared to 10.1 months for patients receiving IV Paclitaxel: with a hazard ratio of 0.593 (95.5% CI 0.382 – 0.921) favoring Oral Paclitaxel. Although metastatic breast cancer patients with mild hepatic dysfunction at baseline are at increased risk of early serious neutropenic and infectious/septic complications this risk may be counterbalanced by a potential increase in efficacy after treatment with Oral Paclitaxel.
Details of the poster presentation is as follows:
Abstract Title: Oraxol + Encequidar (OPac+E) vs IV paclitaxel (IVPac) in the treatment of patients with metastatic breast cancer (mBC) (Study KX-ORAX-001): Subgroup survival analysis of patients with hepatic dysfunction
Session: 1
Program Number: P1-16-05
Date and Time: Wednesday, December 8, 2021. 7:00 am CT