Exelixis, Bristol Myers To Evaluate XL092-Immuno-oncology Therapies In Advanced Solid Tumors

Exelixis Inc. (EXEL) said Monday that it has reached a clinical trial collaboration and supply agreement with Bristol-Myers Squibb Co. (BMY) for STELLAR-002, a new phase 1b trial evaluating XL092 in combination with immuno-oncology therapies in advanced solid tumors.

The study will evaluate the safety, tolerability and efficacy of XL092, Exelixis' novel next-generation tyrosine kinase inhibitor (TKI), in combination with: nivolumab (OPDIVO); nivolumab and ipilimumab (YERVOY); and nivolumab and bempegaldesleukin.

Exelixis is sponsoring STELLAR-002 and Bristol Myers Squibb will provide nivolumab, ipilimumab and bempegaldesleukin for use in the trial.

Nektar Therapeutics (NKTR) will supply bempegaldesleukin to Bristol Myers Squibb through their existing global development and commercialization collaboration, which is evaluating nivolumab in combination with bempegaldesleukin, an investigational CD122-preferential IL-2-pathway agonist.

STELLAR-002 will begin with a dose-escalation phase to determine the recommend dose for each of the XL092 combination therapies: XL092 in combination with nivolumab, XL092 in combination with nivolumab and ipilimumab and XL092 in combination with nivolumab and bempegaldesleukin.

Depending on the dose-escalation results, the trial may enroll patients with the genitourinary cancers. Genitourinary cancers are those that affect the urinary tract, prostate, testicles or penis — parts of the body involved in reproduction and urine production and excretion — and include renal cell carcinoma (RCC), castration-resistant prostate cancer (CRPC) and urothelial carcinomas.

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