Pfizer Inc. today announced that the independent Data Monitoring Committee for the Phase 3 ATLAS trial evaluating INLYTA (axitinib) as adjuvant therapy for patients at high risk of recurrent renal cell carcinoma (RCC) after nephrectomy recommended stopping the trial at a planned interim analysis due to futility. The recommendation was based on the study failing to demonstrate a clear improvement in the primary endpoint of extending disease-free survival (DFS) for patients treated with INLYTA compared with patients treated with placebo. No new safety signals were observed, and the safety profile was consistent with the known profile of INLYTA in advanced RCC.
“We are disappointed by the outcome of this study as we had hoped the efficacy that INLYTA has demonstrated as a second-line treatment in patients with advanced renal cell carcinoma would carry over to patients with earlier stage disease, where it would delay or prevent disease relapse. That goal was not achieved. We will conduct additional analyses on the data that may provide insight into this result. Studies evaluating INLYTA in combination with immune checkpoint inhibitors for patients with a variety of advanced stage cancers, including RCC, will continue,” said Mace Rothenberg, M.D., Chief Development Officer, Oncology, Pfizer Global Product Development.
Detailed efficacy and safety data from ATLAS will be submitted for presentation at a future medical meeting.
INLYTA has had a significant impact on the treatment of patients with advanced RCC worldwide in its currently approved indications, supported by an extensive body of evidence in scientific literature including more than 50 publications. More than 66,000 patients have been treated with INLYTA to date.
About ATLAS
ATLAS (A Randomized Double-Blind Phase 3 Study of Adjuvant Axitinib Versus Placebo in Subjects at High Risk of Recurrent RCC)(NCT01599754) is a global, multicenter, randomized double-blind Phase 3 trial that investigated the clinical efficacy and safety of adjuvant INLYTA (5 mg twice daily) versus placebo in patients (n=724) at high risk of recurrent RCC following nephrectomy. Patients were dosed up to 3 years (for a minimum of 1 year) in the study and the primary endpoint was disease-free survival (DFS). The study was conducted in collaboration with SFJ Pharmaceuticals, who provided the funding and clinical development supervision to generate the clinical data.
Filed Under: Drug Discovery
