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Nexavar fails to meet primary endpoint in HER-2–negative breast cancer
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Results from a phase 3 trial have found that sorafenib plus capecitabine did not meet its primary endpoint of improving PFS for the treatment of locally advanced or metastatic HER-2–negative breast cancer, manufacturers Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals reported.
The phase 3, double-blind, placebo-controlled study – RESILIENCE – evaluated sorafenib (Nexavar, Bayer) in combination with capecitabine (Xeloda, Hoffmann-La Roche) in 537 patients with patients with locally advanced or metastatic HER-2–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.
Patients were randomized to receive 600 mg of oral sorafenib or matching placebo daily on a continuous schedule, in addition to 1000mg/m2 of capecitabine twice daily for 14 days of a 21-day cycle.
The primary endpoint of the study was PFS. Secondary endpoints included OS, time to progression, overall response rate, disease control rate, duration of response and patient reported quality of life and safety.
“We are disappointed that the trial did not show an improvement in progression-free survival in patients with advanced breast cancer,” Joerg Moeller, member of the Bayer HealthCare Executive Committee and head of Global Development, said in a press release. “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.”