NEW YORK—Pfizer Inc. announced Dc. 29 that it ended a PhaseIII study of its experimental lung cancer drug figitumumab after an analysisshowed the drug had been associcated with an unexpected number of deaths intesting among patients.
According to Pfizer, an analysis by an independent datasafety monitoring committee (DSMC) showed that the addition offigitumumab—which was being studied as a first-line treatment in patients withwith advanced non-adenocarcinoma non-small cell lung cancer (NSCLC)—topaclitaxel plus carboplatin would be unlikely to meet the primary endpoint ofimproving overall survival compared to paclitaxel.
This was not the first bit of bad news about the study.Patient enrollment for the study was halted in September 2009 when the DSMCobserved an apparent imbalance of certain serious adverse events between thetreatment arms with more events, including fatalities, occurring in patientswho were randomized to receive figitumumab.
"While these findings are disappointing, Pfizer is committedto using information gained from this study to refine the design of futuretrials of figitumumab in non-small cell lung cancer," said Dr. Mace Rothenberg,senior vice president of clinical development and medical affairs for Pfizer'soncology business unit, in a statement. "We are hopeful that we will be able toidentify a subset of patients who may have derived benefit from the addition offigitumumab to chemotherapy. If this can be done, then future trials will focuson this group of patients in our efforts to deliver this drug to the rightpatient."
Pfizer said it will study figitumumab in clinical trials forthe potential treatment of other cancers, including prostate and breast cancers,and Ewing's sarcoma.
The news met with disappointment by analysts, who hadestimated that the drug could have more than $1 billion in sales in 2015 if itwon approval from regulators.
"The failure is particularly disappointing because offigitumumab's strong Phase II results in patients with squamous cellhistology," says Motley Fool contributor Brian Orelli. "Other drugs likeNexavar, from Bayer and Onyx Pharmaceuticals, have shown negative effects inthat cell type, leaving the market wide open. It's possible that the sideeffects in the ended trial were due to the specific combination of figitumumab,paclitaxel and carboplatin, but investors shouldn't hold their breath. Thecompany is also testing figitumumab in other cancers, and it may still work,but I'd hold off on penciling it in as the next Gemzar, which Eli Lilly hasgotten approved for four different cancer types. We need to see whether theside effects are specific to figitumumab or to the combination before we'llknow whether there's more good news than bad in figitumumab's future."
Bloggingstocks.com analyst Mark Fightmaster says that Pfizerhas enough short-term support to weather the negative study news, but it's "thelong-term picture for the company that is a little out of focus, and a tad bitscary."
"Technically, shares of Pfizer are in place to enjoy a bitof support from the $18 level and its 10-week moving average," Fightmaster says."The shares fared well throughout 2009, advancing from a 2009 nadir of $11.62hit in early March. The problem Pfizer faces rests overhead in the form of the$20 level. If the $20 level falls by the wayside, the stock may find a bit of astruggle with its 50-month moving average. This long-term moving average cappedthe equity's rally attempts in 2006 and 2007. Don't be surprised if it happensagain."
Following the news, shares of Pfizer fell 4 cents to $18.52in after-hours trading.
