Pfizer announced that single-agent, oral Sutent (sunitinib malate) prolonged progression-free survival (PFS) across all patient risk groups, including those with the poorest prognoses for survival versus interferon-alfa (IFN-a), according to new data from the phase III trial in the first-line treatment of advanced renal cell carcinoma (RCC). These data, along with phase II studies of Sutent in several tumour types, including liver cancer, were presented at the 43rd American Society of Clinical Oncology (ASCO) Annual Meeting.
Advanced renal cell carcinoma, a rare but serious type of kidney cancer, is among the most treatment-resistant tumours. More than 200,000 people in the United States live with kidney cancer and approximately 12,890 people will die from this disease this year.
"Sutent research is helping to reshape the treatment landscape in advanced kidney cancer," said Dr Robert Motzer, attending physician at Memorial Sloan-Kettering Cancer Centre and lead investigator on the Sutent phase III trial in RCC. "The longer progression-free survival benefit seen across all patient subgroups studied builds on an extensive body of evidence demonstrating the efficacy and safety of Sutent in the treatment of advanced kidney cancer."
Sutent is a multi-kinase inhibitor which works by inhibiting angiogenesis, one of the processes by which tumours acquire blood vessels bringing oxygen and nutrients needed for growth, and proliferation, the process by which cells multiply. The updated analysis from the randomized phase III trial of 750 previously untreated patients with advanced RCC also demonstrated that:
Sutent more than doubled PFS versus IFN-a (11 months vs. 5.1 months) Sutent was associated with a significant improvement in objective response rate (ORR), a measurable response in tumour size, compared with IFN-a, according to both investigator assessment (46 % vs. 12 %) and independent central review (39 %vs. 8 %).
Additionally, data from an ongoing, multi-centre, open-label, expanded access study of single-agent Sutent in more than 2,000 patients with RCC were also presented today at ASCO. These data include difficult-to-treat patients such as those with brain metastases, non-clear cell kidney cancer and Eastern Cooperative Oncology Group (ECOG) status greater than or equal to two, and confirm the safety profile of Sutent.
Pfizer is committed to further exploring the effect of Sutent in additional advanced kidney cancer populations. Currently underway are two phase III trials studying the role of Sutent as an adjuvant therapy, immediately after surgery, in patients at risk for cancer recurrence.
"The promising results we continue to see with Sutent, as both a single agent and in combination with chemotherapy, further highlight the role that Sutent may play in the treatment of numerous cancers," said Charles Baum, MD PhD, head of oncology development at Pfizer. "Based on this evidence, Pfizer is exploring the potential utility of Sutent through phase III clinical trials in some of the most prevalent and difficult to treat forms of cancer, including breast, liver, colorectal and lung cancer."