Pfizer Inc. 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.

Each year, approximately 338,000 new cases of kidney cancer are diagnosed worldwide, representing approximately 2-3 per cent of all cancers. Renal cell carcinoma (RCC) is the most common type of kidney cancer, accounting for around 90 percent of cases. Approximately 75 per cent of patients with clear cell RCC are non-metastatic, and 70-80 per cent will have a nephrectomy with curative intent, or surgical removal of the tumor. However, a subset will relapse after surgery and once their disease becomes metastatic, their long-term prognosis is poor in advanced RCC with a 5-year survival rate as low as 12%.

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.

Inlyta is an oral therapy that is designed to inhibit tyrosine kinases, including vascular endothelial growth factor (VEGF) receptors 1, 2 and 3; these receptors can influence tumor growth, vascular angiogenesis and progression of cancer (the spread of tumors). In the US, Inlyta is approved for the treatment of advanced renal cell carcinoma (RCC) after failure of one prior systemic therapy. Inlyta is also approved by the European Medicines Agency (EMA) for use in the EU in adult patients with advanced RCC after failure of prior treatment with sunitinib or a cytokine.