Pfizer Inc (PFE) Wednesday announced that the Phase 3 study of INLYTA did not meet its primary endpoint of demonstrating statistically significantly longer progression-free survival, or PFS versus sorafenib, in treatment-naïve patients with advanced renal cell carcinoma, or RCC.
"We narrowly missed the primary endpoint in this trial," said Dr. Mace Rothenberg, senior vice president of clinical development and medical affairs for Pfizer's Oncology Business Unit. "We are analyzing the study findings to determine whether further evaluation of INLYTA in specific subpopulations of treatment-naïve patients with advanced RCC would be warranted."
The healthcare company stated that a preliminary review of the data showed that overall the median PFS for INLYTA exceeded the median PFS for sorafenib, but did not meet statistical significance. In a pre-specified subgroup of patients classified as good Performance Status, the median PFS for INLYTA exceeded the median PFS for sorafenib. In another pre-specified subgroup of patients classified as intermediate Performance Status, there was no difference between INLYTA and sorafenib.
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