- The addition of nivolumab to low dose tivozanib after prior immune checkpoint inhibitor (ICI) is not superior to standard dose tivozanib alone; as a result, the primary endpoint was not met
- Tivozanib monotherapy (control arm) results provide clinically meaningful efficacy and safety data following front-line ICI combinations
- Safety results reinforce tivozanib is well-tolerated
- Data to be submitted to upcoming scientific meeting
Reno, Nevada (UroToday.com) -- AVEO Oncology, an LG Chem company (“AVEO”), announced that the TiNivo-2 Phase 3 clinical trial in patients with advanced metastatic renal cell carcinoma (RCC) whose tumors had progressed following prior immune checkpoint inhibitor (ICI) treatment did not meet the primary endpoint of increasing progression free survival (PFS) when nivolumab was added to low dose (0.89 mg) FOTIVDA® (tivozanib). Importantly, the clinical trial’s control arm using FOTIVDA as monotherapy at the standard dose (1.34 mg) demonstrated a clinically meaningful outcome in median PFS in the second-line following ICI combination therapy. These results build on the prior ICI dataset from the TIVO-3 clinical trial, FOTIVDA’s pivotal phase 3 study, and further support the approved use of FOTIVDA as a safe and effective treatment option in relapsed or refractory advanced RCC following two or more prior systemic therapies.
The results from the TiNivo-2 clinical trial are consistent with other recent RCC phase 3 trials in a similar patient population, making this the second phase 3 clinical trial to suggest that there is no clinical benefit derived from rechallenging RCC patients with immunotherapy after receiving ICI beyond progression on previous ICIs.
“The PFS and safety of the FOTIVDA control arm in the second-line following ICI combinations adds to the growing body of evidence of the importance of a highly selective anti-VEGFR TKI therapy as an effective, well-tolerated treatment option for relapsed or refractory RCC patients treated with prior ICI combination therapy,” says Michael P. Bailey, AVEO Oncology Chief Executive Officer and President. “While the addition of an ICI to low dose FOTIVDA did not improve PFS outcomes after prior ICI, we consider the control arm data an important, evidence-based and clinically meaningful contribution to the oncology community treating relapsed or refractory advanced RCC following front-line ICI combinations.”Toni Choueiri, M.D., Director of the Lank Center for Genitourinary Oncology, Director of the Kidney Cancer Center at Dana-Farber Cancer Institute, Jerome and Nancy Kohlberg Chair and Professor of Medicine at Harvard Medical School, and lead investigator comments, “The PFS and safety results from the control arm support tivozanib as an effective and well-tolerated treatment option in the second-line following an ICI combination as prior systemic therapy.”
The TiNivo-2 clinical trial was designed to evaluate the benefit of adding nivolumab, a PD-1 checkpoint inhibitor, to low dose FOTIVDA versus standard dose FOTIVDA in the second-line following ICI combinations or the third-line setting following prior ICI. The TiNivo-2 clinical trial enrolled patients across clinical sites in North America, Latin America, and Europe. Patients with RCC who progressed after receiving immunotherapy were randomized to either tivozanib single agent or in combination with nivolumab. The trial’s primary outcome was progression free survival; secondary endpoints included overall survival, overall response rate, duration of response, and safety.
Detailed findings are expected to be presented at an upcoming medical meeting.
TiNivo-2 Clinical Trial Details
Phase 3 clinical trial designed to evaluate the safety and efficacy of tivozanib in combination with nivolumab, as compared to tivozanib as a monotherapy, in RCC patients whose tumors have progressed following prior immune checkpoint inhibitor therapy, known as the TiNivo-2 trial.
Source: AVEO Oncology. (2024). AVEO Oncology, an LG Chem company, Announces Phase 3 Renal Cell Carcinoma Clinical Trial (TiNivo-2) Results [Press release]. https://www.aveooncology.com/aveo-oncology-an-lg-chem-company-announces-phase-3-renal-cell-carcinoma-clinical-trial-tinivo-2-results/.