Yesterday, Amgen (AMGN) presented data from a phase III trial of its Vectibix in combination with Folfiri (an irinotecan based chemotherapy) as a second-line treatment for metastatic colorectal cancer at the 2009 ECCO 15 – ESMO 34 European Multidisciplinary Congress in Berlin.
In the trial, Vectibix significantly improved progression-free survival (PFS) in patients with tumors containing a specific gene known as KRAS. Tumor KRAS status was confirmed in 91% of the 1,186 patients enrolled in the trial, the highest number ever reported for a second-line trial.
The combination treatment of Vectibix and Folfiri achieved the co-primary endpoint by improving the median PFS by 2 months (5.9 months versus 3.9 months) compared to Folfiri alone. The combination also showed significant improvement (35% versus 10%) in tumor response rate in patients. However, even though the median overall survival was numerically better (14.5 months versus 12.5 months), it did not achieve statistical significance for Vectibix.
Amgen is also looking at Vectibix as a first-line treatment option. A study known as PRIME showed patients had a 1.6-month benefit for progression-free survival when treated with Vectibix as a first-line therapy.
Colorectal cancer is the fourth most common cancer in men and the third most common cancer in women worldwide. With more than 630,000 deaths worldwide per year, it is the second leading cause of cancer-related death in the Western world.
Although Vectibix is a key product in the anti-epidermal growth factor receptor therapy, Erbitux dominates the market. Erbitux, which recorded sales of $1.6 billion in 2008, was discovered by ImClone, a part of Eli Lilly (LLY), and is sold by Merck KGaA and Bristol-Myers Squibb (BMY). Amgen is trying hard to increase its presence in this market. We have a Neutral rating on the stock.
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