Pfizer announced today that the independent Data Monitoring Committee for the Phase 3 ATLAS trial evaluating Inlyta 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.(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.
“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.
Each year, approximately 338,000 new cases of kidney cancer are diagnosed worldwide, representing approximately 2-3 percent of all cancers. Renal cell carcinoma (RCC) is the most common type of kidney cancer, accounting for around 90 percent of cases.5 Approximately 75 percent of patients with clear cell RCC are non-metastatic, and 70-80 percent 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%.
According to the American Cancer Society, approximately 63,000+ people will be diagnosed with kidney cancer in the US each year. Kidney cancer is among the 10 most common cancers in both men and women. Overall, the lifetime risk for developing kidney cancer in men is about 1 in 48. The lifetime risk for women is 1 in 83.