Exelixis, Inc. (NASDAQ:EXEL) today reported updated interim data from the cohort of patients with metastatic castration-resistant prostate cancer (CRPC) treated with cabozantinib (XL184) in an ongoing phase 2 adaptive randomized discontinuation trial. The data support the findings that cabozantinib reduces or stabilizes metastatic bone lesions in nearly all patients evaluable by bone scan, reduces bone pain and narcotic analgesic medication and results in an increase in hemoglobin in patients with anemia. The data also suggest that cabozantinib shows an encouraging early signal of durable clinical benefit in both docetaxel-naïve and pretreated patients.
“Cabozantinib may offer a unique approach to the treatment of prostate cancer, particularly due to its effect on metastatic bone lesions, which are a key factor of morbidity and mortality in this disease and represent a major unmet medical need.”
David C. Smith, M.D., Professor, Departments of Internal Medicine and Urology at the University of Michigan, presented the data on Thursday, February 17 in a poster session at the American Society of Clinical Oncology's 2011 Genitourinary Cancers Symposium (Abstract #127) in Orlando, Florida.
As of the January 27, 2011 cut-off date, accrual in this cohort was complete at 168 patients, randomization was halted, and randomized patients were unblinded based on an observed high rate of clinical activity.
The efficacy-evaluable population for tumor response per mRECIST includes 100 patients with at least 12 weeks of follow-up. The bone scan evaluable population includes 62 patients with a baseline bone scan, evidence of bone metastasis, and at least 1 post-baseline assessment. All patients had measurable soft tissue disease, approximately half (47%) had evidence of visceral disease (e.g., liver or lung), and approximately half (47%) were docetaxel-pretreated.
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