Phase 3 Trial of Oraxol for Metastatic Breast Cancer Is Fully Enrolled

Phase 3 Trial of Oraxol for Metastatic Breast Cancer Is Fully Enrolled

The Phase 3 trial assessing Athenex‘s Oraxol — an oral formulation of the chemotherapy paclitaxel — for the treatment of advanced breast cancer has completed its planned patient enrollment.

The progression of the study is following the anticipated schedule and the first data is expected to be available in the middle of the year, the company announced.

Oraxol is being developed as an alternative approach for treating tumors that are responsive to paclitaxel without the risk of infusion-related adverse reactions. In addition to paclitaxel, Oraxol also contains an inhibitor of a pump that prevents the intestine from properly absorbing chemotherapeutic agents.

Inhibiting this pump, HM30181, is expected to increase the absorption of paclitaxel by the gastrointestinal tract, increase its levels in the body, and produce better results.

Available clinical data suggests that oral chemotherapy plus HM30181 may yield a better clinical response and tolerability profile than intravenous injections. This is largely attributed to the new oral formulation’s improved stability and overall distribution in the body.

Oraxol was created under the Orascovery treatment development platform, which aims to develop several oral chemotherapeutic agents using the proprietary HM30181 compound. The platform was originally developed by Hanmi Pharmaceuticals, but Athenex acquired exclusive rights for all major worldwide territories except Korea, which is retained by Hanmi.

The ongoing Phase 3 study (NCT02594371) is evaluating the safety, tolerability, and anti-tumor activity of Oraxol in 360 women with confirmed metastatic breast cancer, for whom intravenous paclitaxel had been recommended by their physicians.

Participants were recruited at 45 sites across South America. They randomly received either oral Oraxol (240 patients) — 30-mg capsules of paclitaxel and 15-mg tablets of HM30181 — or paclitaxel injected into the blood (120 patients).

The trial’s main goals are to measure the proportion of patients achieving a response to treatment, and to determine its safety and tolerability through incidence of adverse events and severe adverse events, blood and urine analysis, and cardiac and physical performance.

Secondary measures include the time to disease progression or death and overall survival, examined for a period of two years.

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