Tivozanib improves disease control in advanced renal cell carcinoma
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Tivozanib induced a significantly higher disease control rate than sorafenib among patients with relapsed or refractory advanced renal cell carcinoma, according to study results presented at International Kidney Cancer Symposium.
The benefit persisted across all subgroups and increased with additional follow-up.
“The odds of achieving disease control with tivozanib were double those with sorafenib at week 8, increased from week 8 to [week] 16, and were maintained to week 24,” Sumanta K. Pal, MD, professor in the department of medical oncology and therapeutics research and co-director of the kidney cancer program at City of Hope, and colleagues wrote. “[This suggests] both ongoing and incremental benefit over time.”
Tivozanib (Fotivda, AVEO Oncology), 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 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).
Tivozanib-treated patients achieved significantly longer median PFS (5.6 months vs. 3.9 months; HR = 0.73; 95% CI, 0.56-0.94) and a higher overall response rate (18% vs. 8%; P = .02).
“The likelihood of measurable renal cell carcinoma tumor response diminishes after [two or more] lines of therapy, and the clinical relevance of prolonged stable disease is increasingly important,” Pal and colleagues wrote. “Previous research in advanced renal cell carcinoma suggests that improvement in disease control rate may correlate with longer-term survival and underscores the contribution of stable disease to patient-level outcomes.”
In exploratory analyses, Pal and colleagues evaluated disease control rate and the probability of disease control to assess the magnitude of benefit with tivozanib relative to sorafenib over time.
Researchers defined disease control rate as the percentage of patients who achieved complete response, partial response or stable disease. They classified patients with missing or unevaluable scans as having progressive disease.
Results showed higher disease control rates with tivozanib at 8 weeks (82.3% vs. 69.1%; OR = 2.07; P = .0045), 16 weeks (64.6% vs. 44.6%; OR = 2.27; P = .0002) and 24 weeks (46.9% vs. 27.4%; OR = 2.33; P = .0002).
The improved odds of disease control with tivozanib persisted across subgroups categorized by age, International Metastatic RCC Database Consortium (IMDC) risk score, prior lines of therapy and previous immunotherapy treatment.
“However, the IMDC poor-risk subgroup had an OR close to 1 at week 8, suggesting that rapid progression in this population was likely regardless of treatment received,” Pal and colleagues wrote.
The findings suggest disease control is “an important endpoint” for patients with relapsed or refractory renal cell carcinoma receiving third- or fourth-line treatment, researchers added.
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Pal SK, et al. Abstract N24. Presented at: International Kidney Cancer Symposium; Nov. 5-6, 2021; Austin, Texas.
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