Tivozanib confers long-term PFS benefit in advanced renal cell carcinoma
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Tivozanib improved long-term PFS compared with sorafenib among patients with relapsed or refractory advanced renal cell carcinoma, according to study results.
Five times as many patients assigned tivozanib (Fotivda, AVEO Oncology) remained progression free at 36 months, findings presented at International Kidney Cancer Symposium: North America showed.
Tivozanib, a VEGF receptor tyrosine kinase inhibitor, is approved in the United States for patients with advanced relapsed or refractory renal cell carcinoma who received at least two prior systemic therapies.
The phase 3 TIVO-3 trial — results of which supported the FDA approval — assessed tivozanib vs. sorafenib (Sutent, Pfizer) for patients with metastatic renal cell carcinoma who failed two or three prior systemic regimens, one of which included a VEGF receptor TKI other than sorafenib or tivozanib.
Researchers randomly assigned patients 1:1 to receive 1.34 mg oral tivozanib once daily in 3-weeks-on, 1-week-off cycles (n = 175; median age, 62 years; 72% men) or 400 mg oral sorafenib twice daily continuously in 4-week cycles (n = 175; median age, 64 years; 73% men).
As Healio previously reported, initial results showed tivozanib-treated patients achieved significantly longer PFS per independent review committee assessment (5.6 months vs. 3.9 months; unstratified HR = 0.67; 95% CI, 0.52-0.87; stratified HR = 0.73; 95% CI, 0.56-0.95), a higher overall response rate (18% vs. 8%; P = .02) and longer median duration of response per investigator assessment (20.3 months vs. 9 months).
In the current analysis, Michael B. Atkins, MD, deputy director of Georgetown Lombardi Comprehensive Cancer Center, and colleagues evaluated the proportion of study participants who achieved long-term PFS, with assessments occurring at regular intervals up to 4 years after initiation of their assigned study treatment.
Long-term investigator-assessed PFS analysis continued to show benefit with tivozanib (HR = 0.62; 95% CI, 0.49-0.79).
A higher percentage of tivozanib-treated patients remained progression free at 36 months (12.3% vs. 2.4%) and 48 months (7.6% vs. 0%).
The PFS benefit with tivozanib appeared consistent across subgroups, with higher investigator-assessed PFS rates at 36 months among females (17.5% vs. not estimable), those with favorable-risk status per International Metastatic RCC Database Consortium criteria (17.1% vs. 0%), patients with ECOG performance status of 0 (16% vs. 3.2%) and those aged 65 years or older (15.3% vs. not estimable).
Researchers reported a numerical improvement in OS with tivozanib but the difference did not reach statistical significance (HR = 0.89; 95% CI, 0.7-1.14).
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Atkins MB, et al. Abstract 33. Presented at: International Kidney Cancer Symposium: North America; Nov. 4-5, 2022; Austin, Texas.
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