Exelixis Inc (EXEL)

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Exelixis reports data from a Phase 1 clinical trial of the co's cabozantinib published in the Journal of Clinical Oncology (20.97 -0.03)
Mon May 23 2011 16:57:05 GMT-0400 (Eastern Daylight Time) ET
Co announced the results of the phase 1 clinical trial of cabozantinib in patients with advanced solid tumors or lymphoma have been published in the current issue of the Journal of Clinical Oncology. The publication includes safety data from all 85 patients enrolled in the phase 1 cabozantinib study, and also includes tumor response, genotyping, pharmacokinetic, and pharmacodynamic biomarker data for the 37 patients in the study with medullary thyroid cancer (MTC). Exelixis is currently conducting a phase 3 registration trial of cabozantinib in MTC and, assuming positive results from this registration trial, intends to file a New Drug Application with the U.S. Food and Drug Administration for this indication by the end of 2011. Thirty-five of 37 MTC patients had measurable disease. Partial responses were achieved in 10 of these patients (29%), and 5 of these patients had a partial response at the first radiologic assessment. Responses were observed in patients regardless of prior tyrosine kinase inhibitor therapy status. Seventeen patients (49%) experienced a 30% or greater decrease in the sum of tumor measurements compared with baseline. Stable disease for at least 6 months was observed in 25 of the 37 patients (41%) with MTC, ranging from 6.4 to 31.1 months. Stable disease of at least 3 months was reported in 38% of patients in the non-MTC subset.