The SUN 1087 trial of Stutent (sunitinib malate) combined with erlotinib versus just elrotinib did not improve overall survival in patients with previously treated NSCLC (non-small cell lung cancer), Pfizer Inc. informs. However, the combination therapy did demonstrate a significant improvement in progression free survival..

The study's primary endpoint was overall survival, while progression-free survival was a secondary endpoint. Trial participators and clinicians reported no unexpected types of adverse events (undesirable side effects). Pfizer says its scientists are still analyzing study data, the results have been submitted to the ESMO (European Society for Medical Oncology) Congress, October 8-12, in Milan, Italy.

Dr. Mace Rothenberg, senior vice president of Clinical Development and Medical Affairs for Pfizer's Oncology Business Unit, said:

While this trial did not demonstrate a statistically significant improvement in overall survival for patients treated with sunitinib plus erlotinib, we believe that the statistically significant improvement in progression free survival is an important finding. 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. Pfizer is committed to improving outcomes for patients with lung cancer.

Sutent is currently approved for both gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate, and advanced/metastatic renal cell carcinoma (RCC) based on efficacy and safety data from large, randomized Phase 3 clinical trials.

Pfizer informs that over 91,000 patients worldwide have been treated with Sutent in the clinical setting and in trials.

What is Non-Small Cell Lung Cancer (NSCLC) NSCLC is the most common cancer on the planet, and accounts for approximately 85% of all lung cancer cases. It is very difficult to treat, particularly when metastasized (when it spreads). About 75% of patients with NSCLC are diagnosed with advanced disease. For Stage III/IV NSCLC, the five-year survival rate is only 6 percent.

Source: Pfizer



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