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– Expansion cohorts to include patients with advanced kidney, prostate and bladder cancers –
“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
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.
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,
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
Founded in 1994,
This press release contains forward-looking statements, including, without limitation, statements related to: the therapeutic potential of XL092 in combination with immune-oncology therapies to treat patients with advanced genitourinary cancers; Exelixis’ future development plans for XL092; and Exelixis’ plans to reinvest in its business to maximize the potential of the company’s pipeline, including through targeted business development activities and internal drug discovery. Any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements and are based upon Exelixis’ current plans, assumptions, beliefs, expectations, estimates and projections. Forward-looking statements involve risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in the forward-looking statements as a result of these risks and uncertainties, which include, without limitation: the potential failure of XL092 monotherapy, the combination of XL092 and nivolumab, the combination of XL092, nivolumab and ipilimumab, or the combination of XL092, nivolumab and bempegaldesleukin to demonstrate safety and/or efficacy in STELLAR-002; uncertainties inherent in the product development process; complexities and the unpredictability of the regulatory review and approval processes in the
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1 National Cancer Institute Dictionary of Cancer Terms. Genitourinary System. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/genitourinary-system. Accessed
3 Jonasch, E., Gao, J., Rathmell, W., Renal cell carcinoma. BMJ. 2014; 349:g4797.
4 Zhang T, Gong J, Maia MC, Pal SK. Systemic Therapy for Non-Clear Cell Renal Cell Carcinoma. Am Soc Clin Oncol Educ Book 2017;37:337–42.
5 Cancer Genome Atlas Research Network, Linehan WM, Spellman PT, et al. Comprehensive Molecular Characterization of Papillary Renal-Cell Carcinoma. N Engl J Med 2016;374(2):135–45.
6 Decision Resources Report: Renal Cell Carcinoma.
8 Scher, H.I., Solo, K., Valant, J., Todd, M.B., Mehra, M. Prevalence of Prostate Cancer Clinical States and Mortality in
10 Moreira, D. M., Howard, L. E., Sourbeer, K. N., et al. Predicting Time From Metastasis to Overall Survival in Castration-Resistant Prostate Cancer: Results From SEARCH. Clin Genitourin Cancer. 2017; 15: 60–66.e2.
11 Hurwitz, M. et al. Urothelial and Kidney Cancers. Cancer Management. http://www.cancernetwork.com/cancer-management/urothelial-and-kidney-cancers. Accessed
EVP, Public Affairs and
Executive Director, Public Affairs
and Advocacy Relations