Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy
Elena Verzoni , Bernard Escudier , Thomas E. Hutson , David F. McDermott , Sumanta K. Pal , Camillo Porta , Brian I. Rini , Michael N. Needle , Michael B. Atkins
Background: Tivozanib is a potent and highly selective VEGF receptor (R) tyrosine kinase inhibitor in clinical development for mRCC. Methods: The TIVO-3 study enrolled subjects with mRCC who failed 2 or 3 prior systemic regimens, one of which included a VEGFR TKI, stratified by IMDC risk category and type of prior therapy (two TKIs; TKI plus checkpoint; TKI + other) then randomized 1:1 to T or sorafenib. Tivozanib demonstrated PFS and ORR advantages over sorafenib. Here we report long term durability of response based on investigator assessment and updated overall survival. Results: There were 41 responders (23%) to tivozanib and 20 responders (11%) to sorafenib. The median duration of response (mDoR) was 20.3 months (95% CI: 9.8, 29.9) and 9.0 months (95% CI: 3.7, 16.6) for tivozanib and sorafenib, respectively. With prolonged follow up there were 270 deaths; the HR for overall survival favored tivozanib at 0.91 (95% CI: 0.716, 1.165). Clinical trial information: NCT02627963. Conclusions: Tivozanib treatment in third and fourth line mRCC results in longer PFS, higher objective response rate and more durable responses compared to sorafenib. There is no difference in overall survival.
Treatment | N | Objective Response | Ongoing Response | mDoR in Months (95% CI) | HR (95% CI) |
---|---|---|---|---|---|
Sorafenib | 175 | 20 (11%) | 3 | 9.0 (3.7, 16.6) | 0.55 (0.30, 1.00) |
Tivozanib | 175 | 41 (23%) | 13 | 20.3 (9.8, 29.9) |
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