This week marked another setback for Pfizer (PFE), albeit an expected one. Less than three months after it stopped the enrollment of new patients in a late-stage clinical trial of its experimental lung-cancer drug figitumumab, the world's largest pharmaceutical company announced Tuesday that it had halted the trial altogether.%%DynaPub-Enhancement class="enhancement contentType-HTML Content fragmentId-1 payloadId-61603 alignment-right size-small"%% In the late-stage trial, Pfizer added the investigational compound figitumumab to two chemotherapy drugs in patients with advanced non-adenocarcinoma non-small cell lung cancer (NSCLC). But an analysis showed the addition of figitumumab didn't extend patients' lives compared to patients taking the chemotherapy drugs alone, and Pfizer discontinued the trial.

While certain risks always exist for patients testing new drugs, especially those for cancer, the benefits often outweigh them. So when Pfizer discontinued new patient enrollment in the trial due to certain serious adverse events, including fatalities, it still wasn't a completely open-and-shut case. But when the trial failed to show the needed efficacy, there was no escape.

"While these findings are disappointing, Pfizer is committed to using information gained from this study to refine the design of future trials of figitumumab in non-small cell lung cancer," Dr. Mace Rothenberg, senior vice president at Pfizer's Oncology Business Unit said in a statement. "We are hopeful that we will be able to identify a subset of patients who may have derived benefit from the addition of figitumumab to chemotherapy. "

Planning Ahead for the "Patent Cliff"


Earlier this year, Pfizer seemed very upbeat about figitumumab when it presented the Phase II data. Analysts had estimated that figitumumab sales could reach $400 million to $1.2 billion by 2015, and Pfizer had been counting on the drug to replace some of the revenue it will lose when patents expire on some of its current top sellers, including the biggest-selling drug ever -- Lipitor.

Pfizer has pursued a variety of different strategies to prepare for the upcoming patent cliff it faces in 2011, including restructuring with massive layoffs, completing a mega-merger with Wyeth, making a big push into generics, moving into treating rare diseases, investing in stem cell therapies, and recently, planning to enter the business of making biosimilars. Revamping its pipeline is an integral part of Pfizer's strategy: It has set a goal to boost its global cancer drug sales 10-fold by 2018. Of the 100 medicines Pfizer is testing in human trials, about a quarter are for cancer.

That's why the failure of the figitumumab drug trial is such a setback to Pfizer, and it's just the latest in a series of similar issues this year. Other Phase III clinical trials that were discontinued included those testing Sutent against colorectal cancer and breast cancer, and one testing axitinib's effectiveness against advanced pancreatic cancer. As with figitumumab, none of these drugs reached their efficacy goals in the trials.

"While the clinical development of first-in-class agents in oncology is challenging, Pfizer is determined to provide lung cancer patients with novel, safe and effective therapeutic agents," said Garry Nicholson, senior vice president at Pfizer's Oncology Business Unit. "We remain strongly committed to the figitumumab clinical development program in NSCLC."

Lung cancer remains quite a challenge to drug companies, and patients continue to suffer. It's the most common cancer worldwide, and the NSCLC variants that figitumumab was being tested on account for about 85% of cases.

Pfizer is still studying figitumumab in clinical trials for the potential treatment of other cancers, including prostate and breast cancers, and Ewing's sarcoma, in combination with the Roche (RHHBY) and OSI Pharmaceuticals (OSIP) drug Tarceva.

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