The HealthCare segment at
) and partner, Amgen (
), announced that their oncology drug Nexavar has performed
disappointingly in a phase III study (RESILIENCE: n=537) on breast
Results from the study revealed that treatment with Nexavar in
) 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 (
) and Endo International (
). While Allergan carries a Zacks Rank #1 (Strong Buy), Endo is a
Zacks Ranked #2 stock.
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