Cancer Drugs from Pfizer and Roche Fail in Clinical Trials

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We're not even halfway through March, and it seems the month has already been marked with an abundance of failed drug studies. On March 1, Swiss drugmaker Actelion (ALIOF) reported its drug Tracleer had failed to help reduce mortality in patients with idiopathic pulmonary fibrosis. Two days later, Pfizer (PFE) and Medivation (MDVN) said their experimental Alzheimer's drug Dimebon failed to benefit patients in an advanced study.

Less than a week after that, AstraZeneca (AZN) said that its experimental oncology drug Recentin failed to show any better results than Roche's (RHHBY) Avastin as a treatment for colon cancer in a late-stage, head-to-head trial. That day, Roche and Biogen Idec (BIIB) announced that they were suspending the development of Ocrelizumab for the treatment of rheumatoid arthritis following serious adverse events in studies of the drug, including deaths of patients.

That brings us to this week: On Thursday, Pfizer said two Phase 3 trials of Sutent as a treatment for advanced breast cancer did not meet their primary endpoints. The studies, one for first-line treatment, the other for patients previously treated, used Sutent with standard therapies. Neither study showed a statistically significant improvement in progression-free survival compared with standard therapy alone.

Also on Thursday, the New York-based pharmaceutical stopped a clinical trial of figitumumab in combination with another treatment for patients with previously treated advanced non-small cell lung cancer. That marks the second recent failure for the drug: In December, the world's biggest drugmaker ended a trial of figitumumab as an initial therapy for patients with lung cancer after finding that it didn't extend patients' lives compared to taking the chemotherapy drugs alone.

And on Friday Roche said a late-stage study of its top-selling cancer drug Avastin showed that it failed to extend survival in men with advanced prostate cancer, compared to current treatments. Moreover, a preliminary assessment showed adverse effects already observed in previous trials, Roche said.

A Risky Business: Late-Stage Failures Are To Be Expected


These failed trials are definitely a setback for the companies. Actelion's shares sank over 20% on its Tracleer announcement and Medivation's lost over 60% after its report on Dimebon. Meanwhile, the pharmaceutical industry as a whole is anxiously looking ahead to the next few years, when many blockbuster drugs will lose patent protection and their makers will lose big sales. This spate of failed trials certainly doesn't generate confidence in their ability to bring new products out of the pipeline to compensate for those lost revenues.

Moreover, all of those recent failed trials were of drugs in late-stage studies, highlighting the risky nature of product development in an industry in which failure can be expected even at late stages.

These trials also anecdotally highlight the results of a recent study published this week in the Journal of the American Medical Association that shows that less than a third of drug studies published in major medical journals compare effectiveness across the full range of available treatments to help doctors decide which one is best. Most studies that do compare one treatment with another for effectiveness compare new medicines with available ones, likely because so much research is sponsored by the pharmaceutical industry.

These trial failures are setbacks not only for the drug companies, but for patients. Idiopathic pulmonary fibrosis is a progressive and usually fatal disease of the lung with no approved treatments outside of Japan. Alzheimer's disease is a progressive degenerative brain disorder that is becoming more common, and it remains clinically challenging. Colorectal cancer is the fourth most common cancer in men and women. Rheumatoid arthritis causes painful inflammation of the joints that can lead to deformity and disability, affecting more than 20 million people worldwide.

Breast cancer is the most common cancer and the leading cause of cancer-related death among women globally. Effective therapy for the advanced stages remains a clinical challenge and is desperately needed. Prostate cancer is the second most commonly diagnosed cancer in men worldwide, with some forms in urgent need of new treatment options.
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