NEW YORK—In a phase II, multicenter trial, sunitinib (Sutent) showed activity as a single agent in heavily pretreated non-small-cell lung cancer patients. The overall objective response rate was 11.1%, and median overall survival was 23.4 weeks (Socinski et al: J Clin Oncol 26:650-656, 2008).
Sunitinib, a multi-kinase inhibitor, is currently approved in the United States for the treatment of advanced renal cell carcinoma and gastrointestinal stromal tumors after disease progression on, or intolerance to, imatinib (Gleevec).
The study, led by Mark Socinski, MD, of the University of North Carolina at Chapel Hill, included 64 patients with previously treated stage IIIB or IV NSCLC (nonsquamous and squamous).
They received sunitinib 50 mg once-daily for 4 consecutive weeks in 6-week cycles, followed by 2 weeks off treatment. The majority of the patients (60%) were heavily pretreated, receiving two or more prior systemic therapies.
Of 63 evaluable patients treated with sunitinib, 7 (11.1%) achieved a confirmed partial response (median duration, 21.2 weeks), and 18 had stable disease of at least 8 weeks (median duration, 22.1 weeks). Median overall survival was 23.4 weeks, and median progression-free survival was 12 weeks. The 1-year survival rate was 20.2%.
Adverse events were generally mild to moderate in severity. Three hemorrhage-related deaths occurred, two of which were considered to be treatment related.
Pfizer recently initiated a large, randomized, double-blind phase III trial (SUN 1087) comparing overall survival in previously treated, advanced NSCLC patients taking sunitinib combined with erlotinib (Tarceva) with those taking erlotinib plus placebo. This and other trials of sunitinib are currently open for enrollment (www.suntrials.com).
Sorafenib NSCLC trial halted
Bayer Healthcare Pharmaceuticals and Onyx Pharmaceuticals have announced that a phase III trial evaluating its multi-targeted kinase inhibitor sorafenib (Nexavar) in patients with NSCLC was stopped early following a planned interim analysis. The independent data monitoring committee concluded that the study would not meet its primary endpoint of improved overall survival.
The phase III ESCAPE trial was evaluating sorafenib given in combination with carboplatin and paclitaxel in previously untreated NSCLC of all histologies. Safety events were generally consistent with those previously reported, the company said. However, higher mortality was observed in the subset of patients with squamous cell carcinoma treated with the sorafenib combination vs those treated with carboplatin and paclitaxel alone.
Bayer and Onyx said they have a comprehensive program of clinical trials studying sorafenib for the treatment of NSCLC in a variety of patient populations and in combination with other anticancer regimens. These include the ongoing phase III NExUS study in which previously untreated NSCLC patients are given sorafenib in combination with gemcitabine (Gemzar) and cisplatin.