medwireNews: The phase III TIVO-3 trial has found that both progression-free survival (PFS) and response are significantly better with tivozanib than sorafenib in patients with refractory metastatic renal cell carcinoma (RCC).
Overall survival data were immature at cutoff, but the final analysis is planned for later in the year, presenting author Brian Rini (Cleveland Clinic Taussig Cancer Institute, Ohio, USA) told the audience at the 2019 ASCO Genitourinary Cancers Symposium, held in San Francisco, California, USA.
The trial compared tivozanib – a selective inhibitor of vascular endothelial growth factor receptor (VEGFR) 1, 2, and 3 – with sorafenib, enrolling 350 patients who had received two or three prior systemic regimens for advanced RCC, including at least one VEGFR tyrosine kinase inhibitor.
PFS as assessed by independent review was significantly prolonged for the 175 participants who received oral tivozanib at a daily dose of 1.5 mg for 3 weeks of every 4-week cycle than for the 175 patients treated with sorafenib 400 mg twice a day continuously, at a median of 5.6 and 3.9 months, respectively.
The likelihood of progression or death was therefore 27% lower for tivozanib- than sorafenib-treated patients, and the 1- and 2-year PFS rates were 28% versus 11% and 18% versus 5%, respectively.
Rini commented that the subgroup analyses for PFS were as expected, with the only trend being a gradient from the favorable to poor risk category as per the International Metastatic RCC Database Consortium classification, such that favorable-risk patients derived a greater benefit from tivozanib than those classed as poor risk.
Tivozanib was also associated with a significantly higher rate of objective response, at 18% versus 8% for sorafenib, and the responses were more durable with tivozanib than sorafenib, with the median duration unreached and 5.7 months, respectively.
Forty-four percent of patients in the tivozanib group experienced treatment-related adverse events (AEs) of grade 3 or 4, as did 55% of those in the sorafenib group, the most common being on-target AE hypertension, observed in 20% and 14% of patients, respectively.
The incidence of off-target effects, such as hand–foot syndrome, diarrhea, and rash, was lower among tivozanib- than sorafenib-treated participants, noted the presenter.
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