Patient enrolment milestone for Anthenex’s Oraxol Phase III Study

Expanded breast cancer indication for Lynparza in Europe
Credit: Guschenkova

Athenex has this week successfully enrolled its target of 360 patients in the Oraxol Phase III clinical trial in metastatic breast cancer.

In company update, the biopharma company said that top line data from the study is slated for min-2019.

The study

Oraxol is an innovative oral formulation of paclitaxel, a very effective and commonly used anti-cancer chemotherapy, combined with HM30181A, a novel gastrointestinal tract specific P-glycoprotein pump inhibitor.

The Oraxol Phase III study is an open-label, randomised, multicenter study to determine the safety, tolerability, and tumour response of Oraxol compared with IV paclitaxel in patients with metastatic breast cancer.

Secondary endpoints will measure progression-free survival and overall survival.

The Orascovery platform was initially developed by Hanmi Pharmaceuticals and licensed exclusively to Athenex for all major worldwide territories except Korea, which is retained by Hanmi.