Bayer/Amgen's Nexavar Does Not Show Resilience in Study


The HealthCare segment at Bayer (BAYRY) and partner, Amgen (AMGN), announced that their oncology drug Nexavar has performed disappointingly in a phase III study (RESILIENCE: n=537) on breast cancer.

Results from the study revealed that treatment with Nexavar in combination with Roche’s (RHHBY) Xeloda (capecitabine) failed to improve progression free survival compared to placebo plus Xeloda in advanced breast cancer patients thereby not meeting the study’s primary endpoint. The key secondary endpoints of the study were overall survival, time to progression, overall response rate, disease control rate, duration of response and patient reported quality of life and safety.

The patients evaluated in the study were either resistant to or have failed prior therapies by a taxane/an anthracycline or when further treatment by an anthracycline was not applicable. The companies will report detailed safety and efficacy data from the study at an upcoming medical conference.

We note that this is not the first setback faced by the companies regarding Nexavar this year. In March, the companies announced disappointing results from a phase III study on Nexavar, which was evaluating the clinical benefit of the drug compared to placebo as an adjuvant treatment for patients suffering from hepatocellular carcinoma who had no detectable disease following surgical resection or local ablation. Nexavar failed to meet the primary objective of the study of improving recurrence-free survival.

We are disappointed by the results of these studies aimed at expanding Nexavar's label. We note that Nexavar is already approved for oncology indications like advanced renal cell carcinoma.

Bayer carries a Zacks Rank #3 (Hold). Better-ranked stocks in the healthcare space include Allergan (AGN) and Endo International (ENDP). While Allergan carries a Zacks Rank #1 (Strong Buy), Endo is a Zacks Ranked #2 stock.

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