Pfizer Launches Phase III Trial For Sutent In Non-Small Cell Lung Cancer
This article was originally published in The Pink Sheet Daily
Executive Summary
Positive preliminary Phase II results on sunitinib/erlotinib combination therapy were presented at major lung cancer meeting this week in South Korea.
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Pfizer launched a global Phase III trial testing the effectiveness of its multi-kinase inhibitor Sutent (sunitinib) in combination with Genentech/OSI's epidermal growth factor receptor inhibitor Tarceva (erlotinib) in previously treated patients with advanced non-small cell lung cancer, the company announced Sept. 5. The trial aims to enroll 956 patients. The primary endpoint of the study (SUN 1087) is overall survival of advanced NSCLC patients taking the combination compared to patients taking erlotinib plus placebo. Secondary endpoints include progression-free survival, objective response rate, one-year survival, duration of response, adverse events and patient-reported outcomes. Pfizer reported positive preliminary results from SUN 1058, a Phase II lead-in, safety study of the combination therapy in 12 patients, at the International Association for the Study of Lung Cancer conference in Seoul, South Korea. Patients in that study were given sunitinib 37.5 mg/day continuously with erlotinib 150 mg/day. The most frequent adverse events reported (7) were diarrhea and fatigue. In anti-tumor activity, a secondary endpoint of the study, two patients experienced a partial response that in one case was maintained for >3 months, Pfizer said. The second patient "has a documented durable PR and continues on the study." In addition, stable disease for >=16 weeks was observed in two patients. In June, Pfizer terminated two Phase II and two Phase III trials of a Toll-like receptor 9 agonist it was investigating for NSCLC after a data safety monitoring board determined the risk/benefit profile did not justify continuing the Phase III trials. Pfizer licensed the TLR from Wellesley, Mass.-based Coley Pharmaceutical Group (1 (Also see "Pfizer Halts Lung Cancer Trials Of Toll-Like Receptor Agent" - Pink Sheet, 21 Jun, 2007.)). Following the failure of the TLR, an oligonucleotide, Pfizer has three biologics remaining in its oncology pipeline, all of them internally developed monoclonal antibodies. Data is expected in 2008 from Phase III studies of CP-675206, a CTLA4 inhibitor in studies for melanoma. The other two mAbs are CP-751871, an IGF1R inhibitor in Phase II for metastatic melanoma, and CP-870893, a CD40 inhibitor in Phase I (2 (Also see "Pfizer Pipeline Update Includes Resubmission Plans For Osteoporosis Drug Lasofoxifene" - Pink Sheet, 7 Aug, 2007.)). In the short term, however, the drug giant's cancer market presence is dominated by small molecules: Camptosar (irinotecan) for colorectal cancer, Aromasin (exemestane) for early breast cancer, and Sutent, which had sales of $219 million in 2006. The multi-kinase inhibitor was approved in January 2006 for the treatment of advanced renal cell carcinoma and gastrointestinal stromal tumor after disease progression on or intolerance to imatinib (Novartis' Gleevec ) and had its label updated in February 2007 to reflect approval for first-line RCC (3 (Also see "Sutent Labeling Updated To Reflect First-Line Renal Cell Carcinoma Data" - Pink Sheet, 9 Feb, 2007.)). In addition to NSCLC, Pfizer is studying the oncologic in Phase III trials for advanced breast cancer and advanced colorectal cancer. Phase III studies in advanced liver cancer are also planned for this year. - Shirley Haley ([email protected]) |