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Pfizer lung cancer study disappoints

Pfizer's sunitinib has failed to meet the primary endpoint in a phase III study for non-small cell lung cancer (NSCLC), the company has disclosed

Pfizer's sunitinib, which is already marketed as Sutent in the US for other cancer indications, failed to meet the primary endpoint in a phase III study for non-small cell lung cancer (NSCLC), the company has disclosed.

The trial, known as SUN 1087, compared sunitinib in combination with Roche/Genentech's targeted therapy Tarceva (erlotinib) to Tarceva monothreapy in about 1,000 patients. The topline data showed a statistically significant improvement in progression-free survival in patients with previously treated advanced NSCLC, which was a secondary endpoint. However, his improvement was not found in overall survival in previously treated patients, which was the primary endpoint of the study.

"Over the next few months, we will conduct an in-depth analysis to gain further insight into these results and determine whether we can identify one or more subgroups of non-small cell lung cancer patients for a future trial in either previously untreated or recurrent disease," Dr Mace Rothenberg, senior vice president of Clinical Development and Medical Affairs for Pfizer's Oncology Business Unit, said in a statement.  

Pfizer also noted that the results have been submitted to the European Society for Medical Oncology Congress, which will take place in early October in Milan.

Sutent, an oral multi-kinase inhibitor, is already approved in the US for the treatment of the rare digestive-system cancer gastrointestinal stromal tumor (GIST) after disease progression, as well as for advanced/metastatic renal cell carcinoma. The drug is also in late-stage clinical trials for advanced castration-resistant prostate cancer.

No new or unexpected adverse events were identified during the SUN 1087 study, Pfizer noted. However, potentially fatal hepatotoxicity has been observed in clinical trials and post-marketing experience.

24th August 2010

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