Recently, Bristol-Myers Squibb Co. (BMY) announced positive results from a mid-stage study designed to evaluate its lung cancer drug ipilimumab in combination with standard chemotherapy. The patients enrolled in the study totaling 203 were previously untreated and suffering from advanced non-small cell lung cancer (NSCLC).
The trial, known as 041, studied two distinct regimens of ipilimumab combined with a chemotherapy regimen commonly used to treat patients suffering from advanced NSCLC in the first-line setting compared to the same chemotherapy regimen given alone.
The multi-center, randomized, double blind, three arm study, met the predefined criteria for significant improvement in immune-related progression -free survival (irPFS) compared to chemotherapy alone. An additional analysis of progression-free survival, also met statistical significance in one of the two dosing schedules that combined ipilimumab with standard chemotherapy.
The results from the study indicated that ipilimumab, a novel immunotherapy, which augments the body’s immune response by inhibiting certain proteins, delayed the worsening of advanced NSCLC about a month longer when given with the chemotherapy regimen. The immune-related adverse events in the mid-stage study included gastrointestinal, skin, liver or endocrine systems.
The encouraging data has caused the company to plan a larger late-stage study to evaluate ipilimumab in patients suffering from NSCLC. Ipilimumab, acquired with the acquisition of Medarex in 2009, is being studied for treating other cancer forms too.
Even though, patent expiration will loom large on Bristol in the near future, the company has taken some measures like the Medarex acquisition amongst others to counter the loss of revenues resulting from the patent expirations of its key drugs.
The company intends to launch five other compounds — apixaban, belatacept, brivanib, dapagliflozin and ipilimumab — by 2012, subject to their approval by regulatory authorities. The new launches are expected to drive growth in 2013 and beyond. We have a Neutral recommendation on the stock, which is supported by the Zacks #3 Rank.
Our Neutral stance on the New York based company indicates that the stock is expected to perform in line with the US equity market over the next six to twelve months. We advise investors to retain the stock over the time period.
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