바이오스펙테이터

by Sungmin Kim

AVEO Oncology, an LG Chem company, announced on July 18th 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).

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.

According to AVEO, 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.

Despite the failure of the phase 3 trial on its primary endpoint, AVEO Oncology insists that 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.

Detailed findings are expected to be presented at an upcoming medical meeting.

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.”

Michael P. Bailey, AVEO Oncology Chief Executive Officer and President says, “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.”