Exelixis (EXEL) Updates on Preliminary Cabozantinib Phase 1 Data in Metastatic RCC Patients
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Exelixis, Inc. (Nasdaq: EXEL) reports preliminary data from a cohort of heavily pretreated patients with metastatic refractory renal cell carcinoma (RCC) participating in an ongoing phase 1b trial of cabozantinib. Toni K. Choueiri, M.D., Director of the Kidney Cancer Center at the Dana-Farber Cancer Institute, will present the data (Abstract #364) in a poster session at the 2012 Genitourinary Cancers Symposium at 6:45 a.m. PST tomorrow in San Francisco.
As of the January 18, 2012 data cut-off, 25 RCC patients were enrolled with 88% having received prior anti-VEGF therapy, 60% having received prior mTOR inhibitor therapy, and 52% having received ≥1 anti-VEGF and 1 mTOR therapy. Sixty-four percent of patients received ≥ 2 prior anti-cancer agents. Tumor regression was observed in 19 of 21 patients (90%) with ≥1 post-baseline assessment. Best overall response was determined per RECIST criteria with 7 of 25 patients (28%) showing a confirmed partial response (PR). Importantly, PRs were observed in heavily pretreated patients, including 3 patients with 2-4 prior systemic therapies, and 2 patients with >4 prior systemic therapies. Thirteen additional patients (52%) had stable disease (SD) as their best response, and only a single patient (4%) demonstrated evidence of primary refractoriness to cabozantinib with a best overall response of progressive disease. The rate of disease control (PR + SD) at week 16 for all 25 patients is 72%. Kaplan Meier estimate of median progression-free survival is 14.7 months (95% CI, lower limit 7.3 months – upper limit not reached). Ten patients remain on study and progression free with treatment durations ranging up to 16.4 months.
One patient with symptomatic bone metastases was followed by bone scan. A partial bone scan resolution was observed at week 7 in this patient who had previously been treated with sorafenib, sunitinib, and everolimus. The patient also substantially reduced narcotic use by week 7 and continued on reduced narcotics until week 25. A second patient with bone metastases and bone pain at baseline reported complete resolution of pain by week 4 and remains pain free at week 73.
The data presented are from a cohort of 25 RCC patients enrolled in an ongoing phase 1b drug interaction study of cabozantinib in patients with advanced solid tumors. Patients in this trial receive 140 mg of oral cabozantinib administered daily, and the study endpoints are safety, tolerability, and anti-tumor activity. The RCC patients had histologically confirmed RCC (with clear cell components) and metastases, were refractory to or had progressed following standard therapy, and had measurable disease per RECIST. Bone metastases were present at baseline in 4 patients (16%), one of whom was followed by bone scan.
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As of the January 18, 2012 data cut-off, 25 RCC patients were enrolled with 88% having received prior anti-VEGF therapy, 60% having received prior mTOR inhibitor therapy, and 52% having received ≥1 anti-VEGF and 1 mTOR therapy. Sixty-four percent of patients received ≥ 2 prior anti-cancer agents. Tumor regression was observed in 19 of 21 patients (90%) with ≥1 post-baseline assessment. Best overall response was determined per RECIST criteria with 7 of 25 patients (28%) showing a confirmed partial response (PR). Importantly, PRs were observed in heavily pretreated patients, including 3 patients with 2-4 prior systemic therapies, and 2 patients with >4 prior systemic therapies. Thirteen additional patients (52%) had stable disease (SD) as their best response, and only a single patient (4%) demonstrated evidence of primary refractoriness to cabozantinib with a best overall response of progressive disease. The rate of disease control (PR + SD) at week 16 for all 25 patients is 72%. Kaplan Meier estimate of median progression-free survival is 14.7 months (95% CI, lower limit 7.3 months – upper limit not reached). Ten patients remain on study and progression free with treatment durations ranging up to 16.4 months.
One patient with symptomatic bone metastases was followed by bone scan. A partial bone scan resolution was observed at week 7 in this patient who had previously been treated with sorafenib, sunitinib, and everolimus. The patient also substantially reduced narcotic use by week 7 and continued on reduced narcotics until week 25. A second patient with bone metastases and bone pain at baseline reported complete resolution of pain by week 4 and remains pain free at week 73.
The data presented are from a cohort of 25 RCC patients enrolled in an ongoing phase 1b drug interaction study of cabozantinib in patients with advanced solid tumors. Patients in this trial receive 140 mg of oral cabozantinib administered daily, and the study endpoints are safety, tolerability, and anti-tumor activity. The RCC patients had histologically confirmed RCC (with clear cell components) and metastases, were refractory to or had progressed following standard therapy, and had measurable disease per RECIST. Bone metastases were present at baseline in 4 patients (16%), one of whom was followed by bone scan.
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