GENENTECH ANNOUNCES PRELIMINARY RESULTS FROM TRIAL OF AVASTIN AND TARCEVA IN KIDNEY CANCER
Genentech has performed a preliminary analysis of a randomized Phase II study designed to evaluate the incremental benefit of adding Tarceva (erlotinib) to Avastin (bevacizumab) in metastatic renal cell carcinoma (RCC). This trial measured two co-primary efficacy endpoints, progression-free survival and response rate, and preliminary estimates suggested that the addition of Tarceva to Avastin resulted in progression-free survival and response rates similar to those achieved with Avastin alone.
The exploratory, randomized, double-blind, controlled, multicenter trial enrolled 104 patients with metastatic RCC. Patients were randomized to receive either Avastin with Tarceva, or Avastin with placebo. Patients received Avastin every two weeks, and either Tarceva or placebo daily. All study participants had metastatic RCC of clear cell histology and had undergone prior nephrectomy (surgical removal of all or part of the kidney). Patients who had previously received systemic therapy for RCC (such as chemotherapy) were not eligible to enroll.
A preliminary assessment of safety showed that adverse events in this study were similar to those observed in previous clinical trials of Avastin in combination with Tarceva, and included diarrhea, rash, nausea/vomiting, hypertension, bleeding, proteinuria and pruritus. More detailed information about adverse events will be available when the data are presented.