Patients with renal cell carcinoma (RCC) who were treated with tivozanib (Fotivda) experienced a 26% reduction in the risk of progression or death compared with sorafenib (Nexavar), according to results from the phase 3 TIVO-3 trial.
These are the first and only positive phase 3 study results in the third- and fourth-line setting of RCC, AVEO Oncology–the agent’s manufacturer–noted in a release.
“In the advanced disease setting, these outcomes are particularly meaningful, providing the first large, pivotal dataset that shows sequencing of treatment following earlier TKI and immunotherapy treatment,” principal investigator Brian Rini, MD, director of the Cleveland Clinic’s Genitourinary Cancer Program, said in a press release.
“This profile suggests an important place for tivozanib in the evolving treatment paradigm for RCC and, taken together with early combination data, the need to study tivozanib further in combination with immunotherapies,” he added.
The TIVO-3 trial compared the efficacy of tivozanib with sorafenib in 351 patients with renal cell carcinoma who failed at least 2 prior regimens, including VEGFR-TKI therapy. Progression-free survival (PFS) served as the primary endpoint, while secondary endpoints included overall survival (OS), overall response rate, and safety and tolerability.
The agent demonstrated a 44% improvement in median PFS and a 26% reduction in the risk of progression or death, with a median advantage of 5.6 months in the tivozanib arm compared with 3.9 months in the sorafenib arm.
Among the 26% of patients who previously received checkpoint inhibitor therapy in earlier lines of treatment, PFS was still longer with tivozanib than sorafenib.
OS analysis was not mature at the time of the final PFS analysis, as only 46% of OS events have been reported. AVEO Oncology noted final survival analysis per protocol is planned for August 2019–2 years following the last patient enrolled.
The safety profile of tivozanib appeared consistent with previous studies. The most common side effect with the agent was hypertension, which is known to reflect effective VEGF pathway inhibition, the manufacturer explained.
AVEO Oncology intends to submit a new drug application to the Food and Drug Administration (FDA), and in the meantime, expressed its gratitude toward what has been a long fight: “Our determination to fight for tivozanib in 2015, when AVEO faced an important strategic crossroads, came from our belief that it could have a meaningful impact not just on how a disease was treated, but also what the patient experiences through that treatment,” said Michael Bailey, president and chief executive officer of AVEO Oncology.
“(The trial’s) outcome is the culmination of that multi-year effort, and a first step in our goal to improve both outcomes and patient experience,” he added. “We owe our deepest gratitude to the health care professionals, many of whom long believed in the potential of tivozanib, and to the patients and their families for participating in our pivotal studies.”
Originally published by CURE®
as “Fotivda Lengthens Time to Disease Progression in Renal Cell Carcinoma