There are currently no National Comprehensive Cancer Network® (NCCN) Category 1 recommended agents for patients with advanced RCC who were previously treated with prior immunotherapy. All currently available treatment options for advanced RCC were approved based on clinical studies conducted prior to the introduction of frontline immunotherapy combinations. There is an unmet need to improve the understanding of treatment sequencing and provide new treatment regimens for advanced RCC.
The randomized, controlled, open-label TiNivo-2 Phase 3 study enrolled patients with RCC who have progressed following prior immunotherapy treatment. Patients were randomized 1:1 to receive either low dose FOTIVDA in combination with OPDIVO or standard dose FOTIVDA alone. The TiNivo-2 study’s primary endpoint is progression free survival, with key secondary endpoints to include overall survival, overall response rate, duration of response and safety.
The TiNivo-2 study enrolled across clinical sites in the United States, Canada, Mexico, Europe and South America. “We are very excited to have achieved this interim milestone in the TiNivo-2 study and we are grateful to our global investigators, our AVEO development staff, and especially to the patients who are participating in the study. The TiNivo-2 study addresses an important question in the treatment of RCC, and we continue to work diligently to deliver the study results once data mature,” said AVEO’s Chief Medical Officer, Dr. Martin Birkhofer.
“The TiNivo-2 study will provide us with a robust Phase 3 dataset to answer the outstanding question of whether adding a PD-1 Inhibitor (nivolumab) to a VEGF TKI (tivozanib), provides additional efficacy and acceptable safety over a single agent VEGF TKI following prior immunotherapy,” said Toni Choueiri, M.D., Director, Lank Center for Genitourinary Oncology; Director, Kidney Cancer Center; Jerome and Nancy Kohlberg Chair and Professor of Medicine, Harvard Medical School, Dana-Farber Cancer Institute. “TiNivo-2 is a particularly important study for understanding appropriate sequencing strategies for RCC patients following immunotherapy given the presentation at the 2023 ASCO Annual Meeting of the CONTACT-03 study where adding a PD-L1 inhibitor (atezolizumab) to full dose cabozantinib failed to show a benefit over cabozantinib alone in RCC patients treated with prior immunotherapy.”The Company expects to share initial results from the TiNivo-2 study when the data mature, which is anticipated in the second half of 2024.
Source: AVEO Pharmaceuticals, Inc. (2024). AVEO Oncology Announces Completion of Enrollment in Pivotal Phase 3 TiNivo-2 Study of FOTIVDA® (tivozanib) in Combination with OPDIVO® (nivolumab) in Advanced Renal Cell Carcinoma [Press release]. https://www.aveooncology.com/aveo-oncology-announces-completion-of-enrollment-in-pivotal-phase-3-tinivo-2-study-of-fotivda-tivozanib-in-combination-with-opdivo-nivolumab-in-advanced-renal-cell-carcinoma/.