Tivozanib

In an open-label, phase III, randomized controlled trial, tivozanib was compared with sorafenib as initial targeted therapy. The study included 517 patients with metastatic renal cell cancer with a clear cell component who had received zero to one prior systemic therapy. Prior treatment with VEGF-targeted therapy and mTOR inhibitors was not permitted. The primary end point was PFS.[26]

In an open-label, phase III, randomized controlled trial, tivozanib was compared with sorafenib as initial targeted therapy. The study included 517 patients with metastatic renal cell cancer with a clear cell component who had received zero to one prior systemic therapy. Prior treatment with VEGF-targeted therapy and mTOR inhibitors was not permitted. The primary end point was PFS.[26]

The median PFS was longer for patients who received tivozanib than for patients who received sorafenib (11.9 months vs. 9.1 months; HR, 0.797; 95% CI, 0.639–0.993; P = .042). A total of 156 patients (61%) who had disease progression while receiving sorafenib crossed over to receive tivozanib.[26][Level of evidence B1]

In an open-label, phase III, randomized controlled trial, tivozanib was compared with sorafenib as initial targeted therapy. The study included 517 patients with metastatic renal cell cancer with a clear cell component who had received zero to one prior systemic therapy. Prior treatment with VEGF-targeted therapy and mTOR inhibitors was not permitted. The primary end point was PFS.[26]

There was no difference in OS.

In an open-label, phase III, randomized controlled trial, tivozanib was compared with sorafenib as initial targeted therapy. The study included 517 patients with metastatic renal cell cancer with a clear cell component who had received zero to one prior systemic therapy. Prior treatment with VEGF-targeted therapy and mTOR inhibitors was not permitted. The primary end point was PFS.[26]

The two medications had different toxicity profiles. Adverse events that were more common with tivozanib than with sorafenib included hypertension (44% vs. 34%) and dysphonia (21% vs. 5%). Adverse events that were more common with sorafenib than with tivozanib included hand-foot skin reaction (54% vs. 14%) and diarrhea (33% vs. 23%).

In an open-label randomized controlled trial (NCT02627963), tivozanib was compared with sorafenib. The study included 350 patients with metastatic renal cell cancer who had previously been treated with at least two different systemic therapies, including one VEGF inhibitor.[27]

In an open-label randomized controlled trial (NCT02627963), tivozanib was compared with sorafenib. The study included 350 patients with metastatic renal cell cancer who had previously been treated with at least two different systemic therapies, including one VEGF inhibitor.[27]

With a median follow-up of 19.0 months, the median PFS was longer for patients who received tivozanib (5.6 months vs. 3.9 months; HR, 0.73; 95% CI, 0.56–0.94; P = .016).[27][Level of evidence B1]

In an open-label randomized controlled trial (NCT02627963), tivozanib was compared with sorafenib. The study included 350 patients with metastatic renal cell cancer who had previously been treated with at least two different systemic therapies, including one VEGF inhibitor.[27]

No significant difference was reported for OS. The median OS was 16.4 months for patients who received tivozanib and 19.2 months for patients who received sorafenib (HR, 0.97; 95% CI, 0.75–1.24).[59]

In an open-label randomized controlled trial (NCT02627963), tivozanib was compared with sorafenib. The study included 350 patients with metastatic renal cell cancer who had previously been treated with at least two different systemic therapies, including one VEGF inhibitor.[27]

Grades 3 to 4 treatment-related adverse events were reported in 11% of patients who received tivozanib and 10% of patients who received sorafenib.