Exelixis, Inc. ( EXEL Quick Quote EXEL - Free Report) entered into a clinical collaboration with clinical-stage company Arcus Biosciences ( RCUS Quick Quote RCUS - Free Report) for its phase Ib/II study STELLAR-009.
This study is evaluating zanzalintinib in combination with AB521 in patients with advanced solid tumors, including clear cell renal cell carcinoma (“ccRCC”).
While the study is being sponsored by Exelixis, Arcus is co-funding it and providing AB521 for use. ccRCC is the most common type of kidney cancer in adults.
Zanzalintinib is a next-generation oral tyrosine kinase inhibitor (“TKI”) that inhibits the activity of receptor tyrosine kinases implicated in cancer growth and spread, including VEGF receptors, MET, AXL and MER.
Patient enrollment in the STELLAR-009 study is expected to begin shortly.
The dose-finding stage of the STELLAR-009 study will determine a recommended dose for zanzalintinib in combination with AB521 in patients with advanced solid tumors and patients with advanced ccRCC. The expansion cohorts will then evaluate the tolerability and activity of this combination in ccRCC. It will also assess the contribution of components, supported by activity data generated from monotherapy studies in ccRCC patients, to support full development.
Exelixis is looking to expand its portfolio beyond its lead drug, Cabomteyx, with zanzalintinib.
Zanzalintinib is currently being developed for the treatment of advanced solid tumors, including genitourinary, colorectal and head and neck cancers.
Concurrently, Exelixis initiated a phase II/III STELLAR-305 study evaluating zanzalintinib in combination with
Merck’s ( MRK Quick Quote MRK - Free Report) Keytruda (pembrolizumab) compared with standalone Keytruda in patients with previously untreated PD-L1-positive recurrent or metastatic squamous cell carcinoma of the head and neck (“SCCHN”).
This double-blind phase II/III study will enroll patients with PD-L1-positive recurrent or metastatic SCCHN that is incurable with local therapies. Enrolled patients will be equally randomized in two arms to receive zanzalintinib in combination with Keytruda or placebo in combination with Keytruda. The primary endpoints of the study are progression-free survival (“PFS”) per Response Evaluation Criteria in Solid Tumors (“RECIST”) 1.1 by Blinded Independent Radiology Committee (“BIRC”) and overall survival.
Secondary endpoints include PFS per RECIST 1.1 by investigator and objective response rate and duration of response per RECIST 1.1 by BIRC and by investigator.
Shares of the company have gained 39.8% year to date against the
industry’s decline of 20.7%.
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Cabometyx maintained its status as the leading TKI in the third quarter for the treatment of renal cell carcinoma. This was driven by its use in combination with
Bristol Myers’ ( BMY Quick Quote BMY - Free Report) Opdivo in the first-line setting.
The drug also maintained growth in the hepatocellular carcinoma. Cabometyx prescription volume grew 8% year over year in the third quarter. Management stated that the business remains strong both in terms of demand and new patient starts.
Merck’s Keytruda and BMY’s Opdivo are leading immune-oncology drugs approved for various oncology indications.
EXEL is striving to expand Cabometyx’s label and concurrently develop its portfolio with promising candidates zanzalintnib, XB002, XL102 and CBX-12.
The successful development of additional drugs will broaden its portfolio and reduce its dependence on the lead drug Cabometyx.
However, capturing additional market share in the RCC will be a daunting task for Exelixis, given the competition.
Exelixis currently carries a Zacks Rank #3 (Hold). You can see
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