October 9, 2009 / 7:44 PM / 10 years ago

UPDATE 2-Pfizer halts enrollment in lung cancer trial

* Late-stage trial testing figitumumab

* Says more adverse events found in figitumumab arm

* Pfizer shares close up 1.3 percent (Adds analyst comment, byline)

By Lewis Krauskopf

NEW YORK, Oct 9 (Reuters) - Pfizer Inc (PFE.N) has halted patient enrollment in a late-stage lung cancer trial of its experimental drug, figitumumab, for safety reasons, the drugmaker said on Friday.

The halt was recommended by independent safety monitors overseeing the study. In their review, the monitors found more serious adverse events, including deaths, with patients receiving figitumumab, the company said.

Pfizer said currently enrolled patients may continue their treatment in consultation with their physicians. As of Sept 30, 681 patients were enrolled in the Phase 3 study out of a target of 820, a company spokesman said.

The company said it notified all clinical trial investigators and regulatory agencies and will work closely with the safety monitoring committee on analyzing the data before issuing further guidance.

The enrollment halt is a blow for Pfizer, which is seeking new medicines as many of its top sellers face patent expirations.

Analysts at Cowen & Co had estimated figitumumab would have sales of $400 million in 2015, making it a modest seller by large drug company standards. Leerink Swann analyst Seamus Fernandez had been more optimistic, forecasting global revenue of $1.2 billion in 2015.

After the enrollment halt, however, Fernandez removed potential figitumumab sales from his financial models, noting that metabolic side effects were evident with the drug in mid-stage studies.

“Despite trials in other types of cancer such as breast and prostate, we... were most enthusiastic about prospects for this drug in lung cancer based on Phase 2 efficacy responses,” Fernandez said in a research note.

The analyst lowered his 2015 earnings forecast for Pfizer, which is buying U.S. rival Wyeth WYE.N, by 3 cents per share, to $2.33 per share.

“This is a disappointment, but not unrecoverable for Pfizer,” he said.

In the study, known as Advigo 1016, patients with non-small cell lung cancer receive figitumumab in combination with two older therapies, carboplatin and paclitaxel, or just the older drugs. The goal is to assess the safety and efficacy of figitumumab as a potential initial treatment.

Another Phase 3 lung-cancer study evaluating figitumumab in combination with Roche ROG.VX and OSI Pharmaceuticals’ OSIP.O Tarceva is continuing to enroll new patients, Pfizer said.

Pfizer shares closed up 1.3 percent at $16.92 on the New York Stock Exchange. (Reporting by Lewis Krauskopf; editing by Carol Bishopric)

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