Benzinga | Dec 15, 2021 08:03AM EST

Exelixis Announces Initiation Of Phase 1b Trial Evaluating XL092 In Combination With Immuno-oncology Therapies In Patients With Advanced Solid Tumors

-- STELLAR-002 is second trial to evaluate XL092, a next-generation tyrosine kinase inhibitor, in advanced cancers --

Exelixis, Inc. (NASDAQ:EXEL) today announced initiation of the dose-escalation stage of STELLAR-002, a phase 1b trial evaluating XL092 in combination with immuno-oncology therapies in advanced solid tumors. The objective of the study is to evaluate the safety, tolerability and efficacy of XL092, Exelixis' novel next-generation tyrosine kinase inhibitor (TKI), in combination with: nivolumab (OPDIVO(r)); nivolumab and ipilimumab (YERVOY(r)); and nivolumab and bempegaldesleukin.

Exelixis is sponsoring STELLAR-002, and Bristol-Myers Squibb Company (NYSE:BMY) is providing nivolumab, ipilimumab and bempegaldesleukin for use in the trial, in accordance with their clinical trial collaboration and supply agreement announced in June. Nektar Therapeutics (NASDAQ:NKTR) will supply bempegaldesleukin to Bristol Myers Squibb through their existing global development and commercialization collaboration.

"The initiation of the dose-escalation stage of STELLAR-002, our second phase 1b trial of XL092, is an important step toward evaluating the potential of this next-generation tyrosine kinase inhibitor in combination with three additional immuno-oncology therapies for patients with advanced genitourinary tumors," said Michael M. Morrissey, Ph.D., President and Chief Executive Officer, Exelixis. "We are pleased to continue our successful collaboration with Bristol Myers Squibb through this trial and look forward to identifying the recommended doses for the cohort-expansion stage."

The dose-escalation stage will determine the recommended dose in patients with advanced solid tumors for each of the XL092 combination therapy regimens. Once the recommended dose is established, the trial will begin to enroll tumor-specific expansion cohorts for patients with advanced renal cell carcinoma, urothelial carcinoma and metastatic castration-resistant prostate cancer. The primary efficacy endpoint of the expansion stage will be objective response rates, except for the cohort of patients with metastatic castration-resistant prostate cancer, for which the primary endpoint will be duration of radiographic progression-free survival.