Athenex to Present Subgroup Analysis from Phase 3 Study of Oral Paclitaxel Plus Encequidar (KX-ORAX-001) in Metastatic Breast Cancer at SABCS 2021
Analysis of safety data demonstrated that patients with elevated liver tests were at increased risk of neutropenia related toxicities
Post hoc analysis of this subgroup of patients with hepatic impairment was conducted and showed a median survival rate of 18.9 months in patients treated with Oral Paclitaxel vs 10.1 months in those treated with IV Paclitaxel, with a hazard ratio of 0.59
This increase in overall survival counterbalanced the risk of complications of neutropenia related toxicities
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
For more information, please visit: www.sabcs.org
About Athenex, Inc.
Founded in 2003, Athenex, Inc. is a global clinical-stage biopharmaceutical company dedicated to becoming a leader in the discovery, development, and commercialization of next generation drugs for the treatment of cancer. Athenex is organized around three platforms, including an Oncology Innovation Platform, a Commercial Platform, and a Global Supply Chain Platform. The Company’s current clinical pipeline is derived mainly from the following core technologies: (1) Orascovery, based on P-glycoprotein inhibitor, (2) Src kinase inhibition, and (3) Cell therapy. Athenex’s employees worldwide are dedicated to improving the lives of cancer patients by creating more active and tolerable treatments. For more information, please visit www.athenex.com.
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Source: Athenex, Inc.