Bayer and Onyx’s sorafenib Phase III breast cancer trial fails to meet primary endpoint

28th July 2014 (Last Updated July 28th, 2014 18:30)

Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals have reported results from an investigational Phase III trial of sorafenib (Nexavar) tablets plus capecitabine in patients with advanced breast cancer.

Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals have reported results from an investigational Phase III trial of sorafenib (Nexavar) tablets plus capecitabine in patients with advanced breast cancer.

The Phase III trial called RESILIENCE did not meet its primary endpoint of improving progression-free survival (PFS).

During the trial, the efficacy and safety of sorafenib was evaluated in combination with capecitabine, an oral chemotherapeutic agent, compared to placebo plus capecitabine.

The trial was carried out in patients with HER2 negative breast cancer who are resistant to or have failed prior taxane, and are resistant to or have failed an anthracycline or for whom further anthracycline therapy is not indicated.

"While the primary endpoint of this trial was not met, the results do not affect the currently approved indications for Nexavar."

A total of 537 patients in more than 20 countries, including the US, Europe, Japan and Australia were enrolled in the randomised, double-blind, placebo-controlled Phase III trial.

The primary endpoint of the trial was progression-free survival, while secondary endpoints included overall survival, time to progression, overall response rate, disease control rate, duration of response, and patient reported quality of life and safety.

During the trial, patients were randomised to receive 600mg of oral sorafenib or matching placebo daily on a continuous schedule, in addition to 1,000mg/m2 of capecitabine twice-daily for 14 days of a 21 day cycle.

Bayer HealthCare member of the Executive Committee and head of Global Development Joerg Moeller said: "We are disappointed that the trial did not show an improvement in progression-free survival in patients with advanced breast cancer.

"While the primary endpoint of this trial was not met, the results do not affect the currently approved indications for Nexavar.

"We would like to thank the patients and the study investigators for their contributions and participation in this study."

Based on initial review of the data, the types of adverse events observed were generally comparable with those known for either sorafenib or capecitabine.

Nexavar is an oral anti-cancer therapy currently approved in over 100 countries across the world.

The drug is co-developed by Onyx Pharmaceuticals, an Amgen subsidiary, and Bayer, except in Japan where Bayer is responsible for managing all development.