AVEO Pharmaceuticals, Inc. (NASDAQ:AVEO) recently announced primary analysis of TIVO-3 trial’s positive topline results. It is the randomized, open-label, multi-center, controlled, and Phase-3 study involving comparison of tivozanib with sorafenib in 351 participants suffering from metastatic renal cell carcinoma (RCC) or highly refractory renal cell carcinoma.
TIVO-3 trial demonstrates significant benefits in PFS
The trial met its primary endpoint by demonstrating significant benefit statistically in the progression-free survival (PFS). The trial demonstrated that Tivozanib can bring an improvement of 44% in median PFS and also reduces the progression of the carcinoma cells or towards death by 26%. Compared to 3.9 months PFS for sorafenib, the company worked on 5.6 months median PFS for tivozanib. The patients with RCC participating in the TIVO-3 trial previously failed two prior regimes at least.
Out of these patients, around 26% underwent checkpoint inhibitor therapy in the previous lines of treatment. As compared to sorafenib the Tivozanib PFS for patients receiving and not receiving checkpoint inhibitor therapy was much longer. The secondary endpoint for the overall survival (OS) did not reveal expected maturity at the final PFS analysis time demonstrating only 46% potential of OS events. During the preliminary OS analysis, the OS did not display any significant statistical difference.
Aveo plans final survival analysis in August 2019
As per the protocol the final survival analysis will take place in August next year, exactly two years after the patients enrolled with the trial. The company will submit the detailed results for presentation at a major medical meeting soon. The trial revealed that the overall response rate’s secondary endpoint for patients taking Tivozanib was 18% whereas it was 8% for patients who received sorafenib.
The trial reports indicate that the RCC patients and the grade 3 or patients who faced even higher adverse events in the previous tivozanib trails tolerated tivozanib well. According to Aveo’s president and chief executive officer, Michael Bailey, “We owe our deepest gratitude to the healthcare professionals, many of whom long believed in the potential of tivozanib, and to the patients and their families for participating in our pivotal studies.”