Dr. Motzer Analyzes Overall Survival in the TIVO-1 Study

Robert J. Motzer, MD, attending physician, genitourinary oncology service, Memorial Sloan-Kettering Cancer Center, and professor of medicine, Weill Medical College, Cornell University, discusses the overall survival (OS) results from the phase III TIVO-1 study that compared tivozanib hydrochloride to sorafenib in patients with renal cell carcinoma.

The TIVO-1 trial evenly randomized 517 patients to receive tivozanib or sorafenib. The primary endpoint of the trial was progression-free survival (PFS), which was significantly met and submitted to the FDA for approval. In the trial, the median OS in the tivozanib arm was 28.8 months compared to 29.3 months for those receiving sorafenib (HR = 1.245; P = .105). These results are intriguing, Motzer explains, given the significant improvement in PFS.

Motzer explains that finding an OS advantage was confounded by the trial design, which allowed patients in the sorafenib arm to receive tivozanib following progression. Motzer adds that patients treated with tivozanib did not receive any further targeted therapies after progression. Overall, patients receiving sorafenib received at least two targeted agents whereas those in the tivozanib arm only received one.

This data supports the importance of sequencing therapies and having several available treatment options, Motzer believes. Before the administration of targeted therapies in this space, the OS for patients was near 1 year compared to the 29 months seen in the TIVO-1 trial. Motzer adds that as more therapies are added, survival will continue to increase.

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