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A Lilly Lung Cancer Drug Provides A Welcome Surprise


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In a surprise development, Eli Lilly reported that a drug being developed to treat metastatic squamous non-small cell lung cancer, or NSCLC, increased overall survival in patients during a late-stage trial and there are now plans to seek FDA approval before the end of next year. Although there was precious additional information disclosed, the news was received as a big positive for the drugmaker.

Lilly did note that patients treated with its drug, which is called, necitumumab developed serious, but less frequent adverse events, notably blood clots, indicating a safety issue will be tracked closely (read the statement here). But lung cancer is the leading cause of cancer deaths in the US and NSCLC accounts for 85 percent of all cases. In other words, there is a pressing unmet medical need.

“There is no quantification of the magnitude of the benefit, but given the dearth of therapies to treat this segment of lung cancer patients, achieving overall survival highly likely means the drug will be approved,” Sanford Bernstein analyst Tim Anderson wrote in an investor note. He adds that Lilly has to “validate” manufacturing, suggesting production changes are causing the lag before FDA filing occurs.

“The general tone of the press release doesn’t read as if this was a home run result that will blow people away,” writes ISI Group analyst Mark Schoenabaum in his own investor note. But “the bar (for FDA approval) is relatively low for this disease.” He also points out the drug failed a prior lung trial for safety issues, specifically clotting, and such a caveat could limit market adoption. Still, he forecasts potential annual sales of $1.5 billion, if approved.

Why are the results viewed as surprising? Lilly and Bristol-Myers Squibb BMY +0.51% were jointly developing the drug, but early last year, Bristol-Myers returned the compound. No explanation was given, but analysts divined one reason was a disappointing survival benefit in the previous trial. And Bristol-Myers then turned to one of its own compounds, underscoring speculation that necitumumab was a likely flop.

The drug, by the way, was designed to be an improved version of Erbitux, the flagship medication that was sold by Imclone Systems, which Lilly later acquired. Both drugs target what is called the epidermal growth receptor factor, or EGFR, but Erbitux never showed any benefit in treating NSCLC and so the FDA did not approve Erbitux to treat the disease.

Anderson points out that the Phase III trial - which enrolled 1,093 patients and contrasted the drug with gemcitabine and cisplatin, compared with chemotherapy alone – was not “enriched” by only selecting participants that tested positive for EGFR. So going forward, a key issue in analyzing the results will be whether the overall survival benefit was skewed in favor of patients who tested positive for EGFR. Why? The EGFR mutation can be found in about 20 percent of NSCLC patients in the US.

http://www.forbes.com/sites/edsilverman ... -surprise/

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