Amgen (AMGN) recently presented encouraging data on its oncology candidate AMG 386. The company presented updated data from a randomized phase II study that was conducted in patients suffering from recurrent ovarian cancer. Results from this study were initially presented at the annual meeting of the American Society of Clinical Oncology (ASCO) in June 2010.
The study was conducted with 161 patients who were randomized to receive paclitaxel plus AMG 386 (10 mg/kg) or AMG 386 (3 mg/kg) or placebo. Progression-free survival was the primary endpoint of the study.
Median progression-free survival was 7.3 months and 7.4 months in the 10 mg/kg and 3 mg/kg arms, respectively. The placebo arm demonstrated median progression-free survival of 5 months.
Meanwhile, overall survival was highest in the 10 mg/kg arm at 22.5 months compared to 20.4 months and 20.9 months for the 3 mg/kg and placebo arms, respectively.
Based on these promising results, Amgen is moving the candidate into a phase III randomized, double blind study (TRINOVA-1) that will evaluate AMG 386 in combination with paclitaxel. The study will evaluate the candidate for the treatment of ovarian, primary peritoneal and fallopian tube cancers.
Besides ovarian cancer, AMG 386 is being studied for a wide range of tumor types including renal cell carcinoma, metastatic breast cancer, gastric cancer and colorectal cancer. Results from phase II studies evaluating AMG 386 for other tumor types should be out in the next several months.
Neutral on Amgen
We currently have a Neutral recommendation on Amgen. Amgen received a major boost in July when it received US Food and Drug Administration (FDA) approval for Prolia. Amgen has a lot riding on the successful commercialization of Prolia, and approval for the treatment of bone metastases to reduce skeletal-related events in patients with cancer later this year would be another boost for the stock.
We are bullish on Prolia, but any hiccup, either with respect to delays in gaining approval for additional indications, or a miss in any of the ongoing phase III programs, or safety concerns post-launch, could be expected to weigh heavily on the stock.
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