Patient enrollment for a phase III study was halted recently by Eli Lilly and Company (LLY) and Bristol-Myers Squibb Company (BMY) on the advice of an independent data monitoring committee (DMC). The companies, which are jointly developing necitumumab, an anti-cancer agent, said that they have stopped enrolling patients in one of two phase III studies being conducted with the candidate.
Safety Concerns Raised
The decision to halt enrollment in the INSPIRE study was based on safety concerns raised by the DMC. The DMC said that new or recently enrolled patients should not continue treatment with the candidate due to safety concerns regarding blood clots. However, the DMC noted that patients who have already undergone two or more treatment cycles with necitumumab could continue with the treatment as they appeared to have a lower ongoing risk for blood clots.
The randomized, multi-center, open-label phase III study is being conducted to compare the efficacy of necitumumab plus Alimta and cisplatin with that of Alimta and cisplatin for the first-line treatment of patients suffering from nonsquamous non small cell lung cancer (NSCLC).
Necitumumab continues to be evaluated in another phase III study, SQUIRE, which is evaluating the candidate for the treatment of squamous NSCLC. In this study, necitumumab is being studied in combination with Gemzar and cisplatin. The DMC said that no safety concerns have yet been observed in this study.
Necitumumab became a part of Eli Lilly’s portfolio through its acquisition of ImClone. While Eli Lilly and Bristol-Myers share development costs and any potential commercialization within the US, Canada and Japan, Eli Lilly has exclusive commercialization rights in all other countries.
Our Take
The emergence of safety concerns associated with necitumumab is disappointing. This is the latest pipeline setback for Eli Lilly over the past few months. In Jan 2011 itself, an advisory panel of the US Food and Drug Administration (FDA) voted against approving liprotamase, a non-porcine pancreatic enzyme replacement therapy, for the treatment of exocrine pancreatic insufficiency. Another advisory panel voted against granting approval to the company’s molecular imaging agent, Amyvid, based on currently available data.
Earlier in Dec 2010, the company suspended a phase III study that was being conducted with its metastatic melanoma candidate, tasisulam. The study was put on “full clinical hold” due to safety concerns.
In October, Eli Lilly had announced that Alimta failed to achieve its primary endpoint in a phase III study that was being conducted in patients suffering from recurrent or metastatic squamous cell cancer of the head and neck (SCCHN).
Then in August 2010, Eli Lilly announced that it was halting the development of semagacestat (LY450139), which was in late-stage studies for the treatment of patients suffering from Alzheimer’s disease.
We currently have a Zacks #4 Rank (short-term Sell rating) on Eli Lilly. With Zyprexa slated to lose US patent protection later this year, late-stage pipeline setbacks will weigh heavily on the stock.
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