On October 4, 2022 Exelixis, Inc. (Nasdaq: EXEL) reported 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 (Press release, Exelixis, OCT 4, 2022, View Source [SID1234621673]). 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.
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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. "By studying multiple immune checkpoint combinations, we hope to identify the most promising regimens across multiple solid tumors to use in future pivotal trials."
Enrollment and dosing in the dose-escalation portion of STELLAR-002 is ongoing. The dose-escalation stage will determine the recommended dose in patients with advanced solid tumors for each of the combination therapy regimens, including XL092 and nivolumab, XL092, nivolumab and ipilimumab, and XL092 and the fixed-dose combination of nivolumab and relatlimab.
About XL092
XL092 is a next-generation oral TKI that inhibits the activity of receptor tyrosine kinases implicated in cancer growth and spread, including VEGF receptors, MET, AXL and MER. These receptor tyrosine kinases are involved in both normal cellular function and in pathologic processes such as oncogenesis, metastasis, tumor angiogenesis, and resistance to multiple therapies, including ICIs. In designing XL092, Exelixis sought to build upon its extensive experience with and the target profile of cabozantinib, the company’s flagship medicine, while improving key characteristics, including pharmacokinetic half-life. XL092 is currently being developed for the treatment of advanced solid tumors, including genitourinary cancers, as a monotherapy and in combination with ICIs. XL092 is the first internally discovered Exelixis compound to enter the clinic following the company’s reinitiation of drug-discovery activities.