With updated data for the usefulness of tivozanib, patients with recurrent clear cell renal carcinoma have an effective option for treatment in a treatment landscape previously without many treatment options.
Helen H. Moon, MD, principal investigator with the Cancer Clinical Trials Access Program in the Southern California Permanente Medical Group, research lead for melanoma, regional medical oncology lead for genitourinary cancer, and hematologist/oncologist at Kaiser Permanante Riverside Medical Center, discusses the usefulness of tivozanib (Fotivda) for patients with recurrent clear cell renal cell carcinoma (ccRCC) in the third-line setting.
The efficacy and safety data of this therapy is from the phase 3 TIVO-3 trial (NCT02627963), which randomly assigned patients who had failed 2 or 3 systemic lines of therapy to tivozanib versus sorafenib (Nexavar).
The trial showed that patients receiving tivozanib had a higher median progression-free survival of 5.6 months versus 3.9 months for patients on sorafenib (HR 0.73; 95% CI, 0.56-0.94; P = .016). Moreover, at the time of the primary analysis, the objective response rate was 18% among patients given the tyrosine kinase inhibitor (TKI) compared with 8% for patients given sorafenib.
According to Moon, this demonstrates the impact this therapy can have in the third-line setting for patients who failed several lines of therapy prior. Compared with therapies in the first line setting for patients with ccRCC, there has yet to be as effective treatments for patients experiencing recurrent disease. Now, with tivozanib showing no new safety signals—except for hypertension, which Moon explains is a class effect of TKIs— there is now another option to consider for these heavily pretreated patients.
0:08 | We're increasingly getting patients, when they get to the third line, having already been exposed to both TKI and immunotherapy. And so, what we have left as they enter into that place in treatment is [that] they're looking for effective treatment with increasing awareness of the adverse event profile and tivozanib really fits quite well into that space.
0:35 | There are preclinical data, [and now] certainly with the results of TIVO-3, it really indicates a highly effective therapy and a very potent blocker of the [VEGF pathway] and that compared to sorafenib, which is a representative TKI of that first generation, it is better.