On June 14, 2021 Exelixis, Inc. (Nasdaq: EXEL) reported a clinical trial collaboration and supply agreement with Bristol-Myers Squibb Company (NYSE: BMY) for STELLAR-002, a new phase 1b trial evaluating XL092 in combination with immuno-oncology therapies in advanced solid tumors (Press release, Exelixis, JUN 14, 2021, View Source [SID1234583954]). 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); 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 (Nasdaq: 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.
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"We are excited to expand our development of XL092 with another comprehensive phase 1b trial evaluating its potential in combination with immuno-oncology therapies," said Gisela Schwab, M.D., President, Product Development and Medical Affairs and Chief Medical Officer, Exelixis. "Building on our long-standing and successful collaboration with Bristol Myers Squibb to evaluate our flagship product in combination with their checkpoint inhibitors, we now look forward to this new collaboration focused on XL092 as we explore how our next-generation tyrosine kinase inhibitor may help patients with advanced genitourinary cancers, who often face a poor prognosis or limited treatment options following disease progression."
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 following genitourinary cancers:
previously untreated advanced or metastatic clear cell renal cell carcinoma (RCC)
second-line advanced or metastatic clear cell RCC following treatment with an immune checkpoint inhibitor combination therapy
metastatic castration-resistant prostate cancer following treatment with one novel hormonal therapy
second-line urothelial carcinoma following platinum-based combination therapy
urothelial carcinoma that has progressed following immune checkpoint inhibitors and no more than two prior systemic therapies
previously untreated advanced or metastatic non-clear cell RCC
During the cohort-expansion stage, patients in each cohort will be randomized to multiple treatment arms. To better understand the individual contribution of the therapies, treatment arms may include XL092 monotherapy, XL092 and nivolumab, and combinations of XL092 and nivolumab and ipilimumab or nivolumab and bempegaldesleukin.
About XL092
XL092 is a next-generation oral TKI that targets VEGF receptors, MET, AXL, MER and other kinases implicated in cancer’s growth and spread. In designing XL092, Exelixis sought to build upon the experience and target profile of cabozantinib, the company’s flagship medicine, while improving key characteristics, including pharmacokinetic half-life. XL092 is the first internally discovered Exelixis compound to enter the clinic following the company’s reinitiation of drug discovery activities.
About 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.1
The American Cancer Society’s (ACS) 2021 statistics cite kidney cancer as among the top ten most commonly diagnosed forms of cancer among both men and women in the U.S.2 Clear cell RCC is the most common type of kidney cancer in adults.3 Papillary RCC accounts for about 15% of all renal cell cancers.4,5 If detected in its early stages, the five-year survival rate for RCC is high; for patients with advanced or late-stage metastatic RCC, however, the five-year survival rate is only 13%.2 Approximately 32,000 patients in the U.S. and over 71,000 worldwide will require systemic treatment for advanced kidney cancer in 2021, with nearly 15,000 patients in need of a first-line treatment in the U.S.6
According to the ACS, in 2021, approximately 250,000 new cases of prostate cancer will be diagnosed, and 34,000 people will die from the disease.2 Prostate cancer that has spread beyond the prostate and does not respond to androgen-suppression therapies — a common treatment for prostate cancer — is known as metastatic CRPC.7Researchers estimate that in 2020, 43,000 people were diagnosed with metastatic CRPC, which has a median survival of less than two years.8,9,10
Urothelial cancers encompass carcinomas of the bladder, ureter and renal pelvis at a ratio of 50:3:1, respectively.11 Bladder cancer occurs mainly in older people, with 90% of patients aged 55 or older.12 With an estimated 84,000 new cases expected to be diagnosed in 2021, bladder cancer accounts for about 5% of all new cases of cancer in the U.S. each year.2,13 It is the fourth most common cancer in men.2