Pfizer Inc. (NYSE :PFE) announced today that the SUN 1087 trial of sunitinib in combination with erlotinib versus erlotinib demonstrated a statistically significant improvement in Progression-Free but not in Overall Survival in patients with previously treated advanced non-small cell lung cancer (NSCLC). Overall survival was the primary endpoint of the study and Progression-Free Survival was a secondary endpoint of the study. No new or unexpected types of adverse events were observed in the study. Pfizer is continuing to analyze study data, and the results have been submitted to the European Society for Medical Oncology (ESMO) Congress, October 8-12, 2010 in Milan, Italy.
"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," said Dr. Mace Rothenberg, senior vice president of Clinical Development and Medical Affairs for Pfizer's Oncology Business Unit. "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. Sutent has played a significant role in advancing the treatment landscape and remains standard of care in its approved indications. To date, more than 91,000 patients globally have been treated with sunitinib in the clinical setting and in trials.
Pfizer Oncology is committed to further developing Sutent in other tumor types where there is promise and a need for additional treatment options and continues to evaluate the potential role of Sutent as a treatment for advanced castration-resistant prostate cancer and as adjuvant therapy for renal cell carcinoma in Phase 3 trials.
Pfizer Oncology is dedicated to improving outcomes for patients with lung cancer and has multiple compounds in development to treat the various forms of the disease, including Phase 3 trials for crizotinib (PF-02341066), a first-in-class oral ALK (anaplastic lymphoma kinase) inhibitor, and PF-00299804, an irreversible, oral, selective pan-HER (human epidermal growth factor receptor) inhibitor.