Exelixis Announces Encouraging Results from Phase 1b/2 STELLAR-002 Trial Evaluating Zanzalintinib in Combination with Immune Checkpoint Inhibitors in Advanced Kidney Cancer at ASCO 2025
Zanzalintinib in combination with nivolumab demonstrated an objective response rate of 63% and a disease control rate of 90% –
– Additional results from dose-finding cohorts will also be presented –
Excerpt from the Press Release:
ALAMEDA, Calif.–(BUSINESS WIRE)–May 22, 2025– Exelixis, Inc. (Nasdaq: EXEL) today announced results from an expansion cohort of the phase 1b/2 STELLAR-002 trial evaluating zanzalintinib in combination with either nivolumab (Opdivo®) or a fixed-dose combination of nivolumab and relatlimab (Opdualag™) in patients with previously untreated advanced clear cell renal cell carcinoma (RCC). These findings, as well as data from multiple dose-escalation cohorts from STELLAR-002, will be presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting.
“We are pleased to present these preliminary findings from the phase 1b/2 STELLAR-002 study, including early signs of promising activity for zanzalintinib in combination with immune checkpoint inhibitors,” said Amy Peterson, M.D., Executive Vice President, Product Development & Medical Affairs, and Chief Medical Officer, Exelixis. “Data emerging from this ongoing study are important to help inform further evaluation of zanzalintinib-based regimens in advanced solid tumors, including renal cell carcinoma.”
Abstract 4515: Zanzalintinib + Nivolumab ± Relatlimab in Patients with Previously Untreated Clear Cell Renal Cell Carcinoma: Results from an Expansion Cohort of the Phase 1b STELLAR-002 Study
Lead Author: Jad Chahoud, M.D., M.P.H., Moffitt Cancer Center, Tampa, Fla., USA
Session Title: Genitourinary Cancer—Kidney and Bladder
Saturday, May 31, 1:15-2:45 p.m. CDT
This expansion cohort of STELLAR-002 included patients with advanced clear cell RCC who received zanzalintinib in combination with either nivolumab (n=40) or fixed-dose nivolumab and relatlimab (n=40) in two non-randomized treatment arms.
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