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Exelixis Expands Clinical Trial Collaboration and Supply Agreement with Bristol Myers Squibb to Include the Fixed-Dose Combination of Nivolumab and Relatlimab in Combination with XL092 in Phase 1b STELLAR-002 Trial

— Agreement enables evaluation of XL092 in combination with an additional immune checkpoint inhibitor —

Excerpt from the Press Release:

ALAMEDA, Calif.–(BUSINESS WIRE)–Exelixis, Inc. (Nasdaq: EXEL) today announced the expansion of its June 2021 Clinical Trial Collaboration and Supply Agreement with Bristol-Myers Squibb Company (NYSE: BMY) to include the use of the fixed-dose combination of nivolumab and relatlimab in the ongoing phase 1b STELLAR-002 clinical trial (NCT05176483), which is evaluating XL092 in combination with multiple immune checkpoint inhibitors (ICIs) in advanced solid tumors. Exelixis is sponsoring STELLAR-002, and Bristol Myers Squibb will provide the fixed-dose combination of nivolumab and relatlimab in addition to nivolumab and ipilimumab for use in the trial, which is divided into two parts: a dose-escalation stage and an expansion cohort stage. The novel triplet combination of XL092 and the fixed-dose combination of nivolumab and relatlimab has the potential to be used in multiple expansion cohorts.

XL092 is Exelixis’ next-generation oral tyrosine kinase inhibitor (TKI) that targets VEGF receptors, MET, AXL, MER and other kinases implicated in cancer’s growth and spread. Bristol Myers Squibb’s relatlimab is a lymphocyte activation gene-3 (LAG-3)-blocking antibody. LAG-3 is an inhibitory immune checkpoint expressed on the surface of T cells.

“We are pleased to expand our agreement with Bristol Myers Squibb for the STELLAR-002 trial to include the novel fixed-dose combination of nivolumab and relatlimab to evaluate the potential benefit of combining XL092 with additional immune checkpoint inhibitors,” said Vicki L. Goodman, M.D., Executive Vice President, Product Development & Medical Affairs, and Chief Medical Officer, Exelixis.

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