Sunitinib prolongs PFS in RCC: update

ASCO—An updated analysis from the pivotal phase III trial of sunitinib (Sutent) in 750 previously untreated patients with metastatic renal cell cancer (RCC) has reaffirmed the superior efficacy of sunitinib, compared with interferon-alfa (IFN-a) and shown that the agent prolongs progression-free survival (PFS) across all patient groups, including those with the poorest prognoses. Sunitinib is a multikinase inhibitor that works by inhibiting angiogenesis and cell proliferation.

Lead investigator Robert Motzer, MD, of Memorial Sloan-Kettering Cancer Center (MSKCC), presented the results at the ASCO annual meeting 2007 (abstract 5024).

Previous reports with a data cut-off of November 2005, as determined by independent central review, showed median PFS of 11 months with sunitinib vs 5.0 months with IFN-a (HR 0.415). The updated median PFS results (data cutoff February 2007) were almost identical: 11 months for sunitinib vs 5.1 months for IFN-a (HR 0.538).

The new analysis showed that the PFS benefit with sunitinib vs IFN-a extended across all of the MSKCC risk status groups:

• Favorable risk (0 risk factors): 14.5 months vs 7.9 months with IFN-a.

• Intermediate risk (one to two risk factors): 10.6 months vs 3.8 months.

• Poor risk (three or more risk factors): 3.7 months vs 1.2 months.