On May 21, 2026 Exelixis, Inc. (Nasdaq: EXEL) reported presentations for its flagship product, CABOMETYX (cabozantinib), and its investigational oral kinase inhibitor, zanzalintinib, at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting to be held from May 29 – June 2 in Chicago.
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"The presentations at ASCO (Free ASCO Whitepaper) this year highlight the continued progress of our strategy to build upon the well-established therapeutic profile of CABOMETYX and accelerate the development of zanzalintinib, our next oncology franchise molecule," said Dana T. Aftab, Ph.D., Executive Vice President, Research and Development, Exelixis. "New analyses from the phase 3 CABINET pivotal trial that further reinforce the foundational role of CABOMETYX in patient care, and findings from the phase 3 STELLAR-303 pivotal trial evaluating our investigational therapy, zanzalintinib, in metastatic colorectal cancer, will be presented. These collective data sets are a testament to our team’s dedication to improving the standards of care for patients with cancer."
Studies to be presented at the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting include:
Abstract Title
Presentation
Session Title
Session Date/Time
Cabozantinib
A phase 2 randomized trial of radium-223 dichloride and cabozantinib in patients (pts) with renal cell carcinoma (RCC) with bone metastases (BM): RADICAL (Alliance A031801)
Oral Abstract #4500
Genitourinary Cancer – Kidney and Bladder
Friday, May 29
2:45 – 2:57 p.m. CDT
Interim analysis of CaboMain: A prospective, single-arm phase 2 clinical trial of cabozantinib as maintenance therapy for patients with "ultra-high-risk" pediatric solid tumors
Rapid Oral Abstract #10014
Pediatric Oncology II
Saturday, May 30
8:27 – 8:33 a.m. CDT
Efficacy and safety of cabozantinib (CABO) in advanced neuroendocrine tumors (NET) according to hormone functional status: Subgroup analysis of phase 3 CABINET trial (Alliance A021602)
Poster #161 Abstract #4178
Gastrointestinal Cancer – Gastroesophageal, Pancreatic and Hepatobiliary
Saturday, May 30
9:00 a.m. – 12:00 p.m. CDT
Cabozantinib in high-grade neuroendocrine neoplasms
Poster #166 Abstract #4183
Gastrointestinal Cancer – Gastroesophageal, Pancreatic and Hepatobiliary
Saturday, May 30
9:00 a.m. – 12:00 p.m. CDT
EA3231: A randomized phase 3 study of BRAF-targeted therapy vs cabozantinib in RAI-refractory differentiated thyroid cancer with BRAF V600Em
Poster #589b Abstract #TPS6140
Head and Neck Cancer
Saturday, May 30
1:30 – 4:30 p.m. CDT
Cabozantinib plus nivolumab (C+N) versus sunitinib (S) in patients with advanced renal cell carcinoma (aRCC) and bone metastasis: Updated subgroup analysis of the phase 3 CheckMate-9ER trial
Poster #7 Abstract #4528
Genitourinary Cancer – Kidney and Bladder
Sunday, May 31
9:00 a.m. – 12:00 p.m. CDT
Cabozantinib plus nivolumab (C+N) versus sunitinib (S) in patients with advanced renal cell carcinoma (aRCC) and liver metastasis: Subgroup analysis of the phase 3 CheckMate-9ER trial
Poster #9 Abstract
#4530
Genitourinary Cancer – Kidney and Bladder
Sunday, May 31
9:00 a.m. – 12:00 p.m. CDT
PEMBROCABOSARC: A phase 2 trial combining pembrolizumab and cabozantinib in patients with advanced undifferentiated pleomorphic sarcoma
Rapid Oral Abstract
#11514
Sarcoma
Sunday, May 31
4:42 – 4:48 p.m. CDT
MAIN-CAV: Phase 3 randomized trial of maintenance cabozantinib and avelumab versus avelumab after first-line platinum-based chemotherapy (PBC) in patients (pts) with locally advanced/metastatic urothelial cancer (la/mUC; Alliance A032001)
Rapid Oral Abstract #4514
Genitourinary Cancer – Kidney and Bladder
Monday, June 1
8:00 – 8:06 a.m. CDT
Final results of a phase 2 trial of cabozantinib plus nivolumab (CaboNivo) in patients with non-clear cell renal cell carcinoma (nccRCC)
Rapid Oral Abstract
#4521
Genitourinary Cancer – Kidney and Bladder
Monday, June 1
9:12 – 9:18 a.m. CDT
Survival outcomes of cabozantinib treatment with and without immune checkpoint inhibition in patients with heavily pretreated advanced sarcoma
Poster #341 Abstract #11551
Sarcoma
Monday, June 1
1:30 – 4:30 p.m. CDT
Safety and feasibility of cabozantinib (CABO) in combination with cisplatin, doxorubicin, and high-dose methotrexate (MAP) in patients with newly diagnosed high-risk osteosarcoma (OS)
Poster #281 Abstract #10030
Pediatric Oncology
Monday, June 1
1:30 – 4:30 p.m. CDT
Zanzalintinib
Contribution of atezolizumab (atezo) to the efficacy of the zanzalintinib (zanza) + atezo combination in patients (pts) with previously treated metastatic colorectal cancer (mCRC): Evidence from the phase 3 STELLAR-303 trial
Poster #341 Abstract #3574
Gastrointestinal Cancer – Colorectal and Anal
Saturday, May 30
9:00 a.m. – 12:00 p.m. CDT
ZAMBONI: A phase 2 study of zanzalintinib for metastatic clear cell renal cell carcinoma with bone metastases previously treated with immune checkpoint inhibitors
Poster #110b Abstract #TPS4634
Genitourinary Cancer – Kidney and Bladder
Sunday, May 31
9:00 a.m. – 12:00 p.m. CDT
A phase 2 trial of neoadjuvant zanzalintinib (ZANZA) plus nivolumab (NIVO) in patients with locally advanced and/or surgically challenging clear cell renal cell carcinoma (EXPLORE-RCC)
Poster #108a Abstract
#TPS4629
Genitourinary Cancer – Kidney and Bladder
Sunday, May 31
9:00 a.m. – 12:00 p.m. CDT
LITESPARK-033: Phase 3 study of belzutifan plus zanzalintinib versus cabozantinib for recurrent clear cell renal cell carcinoma during or after adjuvant anti-PD-(L)1 therapy
Poster #110a Abstract #TPS4633
Genitourinary Cancer – Kidney and Bladder
Sunday, May 31
9:00 a.m. – 12:00 p.m. CDT
About CABOMETYX (cabozantinib)
In the U.S., CABOMETYX tablets are approved as monotherapy for the treatment of patients with advanced RCC and in combination with nivolumab as a first-line treatment for patients with advanced RCC; for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib; for adult and pediatric patients 12 years of age and older with locally advanced or metastatic differentiated thyroid cancer (DTC) that has progressed following prior VEGFR-targeted therapy and who are radioactive iodine-refractory or ineligible; for the treatment of adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated pancreatic NET; and adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated extra-pancreatic NET. CABOMETYX tablets have also received regulatory approvals in over 65 countries outside the U.S. and Japan, including the EU. In 2016, Exelixis granted Ipsen Pharma SAS exclusive rights for the commercialization and further clinical development of cabozantinib outside of the U.S. and Japan. In 2017, Exelixis granted exclusive rights to Takeda Pharmaceutical Company Limited for the commercialization and further clinical development of cabozantinib for all future indications in Japan. Exelixis holds the exclusive rights to develop and commercialize cabozantinib in the U.S.
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
Hemorrhage: CABOMETYX can cause severe and fatal hemorrhages. The incidence of Grade 3-5 hemorrhagic events was 5% in CABOMETYX patients in RCC, HCC, and DTC studies. Discontinue CABOMETYX for Grade 3-4 hemorrhage and before surgery. Do not administer to patients who have a recent history of hemorrhage, including hemoptysis, hematemesis, or melena.
Perforations and Fistulas: Fistulas, including fatal cases, and gastrointestinal (GI) perforations, including fatal cases, each occurred in 1% of CABOMETYX patients. Monitor for signs and symptoms, and discontinue CABOMETYX in patients with Grade 4 fistulas or GI perforation.
Thromboembolic Events: CABOMETYX can cause arterial or venous thromboembolic events. Venous thromboembolism occurred in 7% (including 4% pulmonary embolism) and arterial thromboembolism in 2% of CABOMETYX patients. Fatal thrombotic events have occurred. Discontinue CABOMETYX in patients who develop an acute myocardial infarction or serious arterial or venous thromboembolic events.
Hypertension and Hypertensive Crisis: CABOMETYX can cause hypertension, including hypertensive crisis. Hypertension was reported in 37% (16% Grade 3 and <1% Grade 4) of CABOMETYX patients. In CABINET (n=195), hypertension occurred in 65% (26% Grade 3) of CABOMETYX patients. Do not initiate CABOMETYX in patients with uncontrolled hypertension. Monitor blood pressure regularly during CABOMETYX treatment. Withhold CABOMETYX for hypertension that is not adequately controlled; when controlled, resume at a reduced dose. Permanently discontinue CABOMETYX for severe hypertension that cannot be controlled with antihypertensive therapy or for hypertensive crisis.
Cardiac Failure: CABOMETYX can cause severe and fatal cardiac failure. Cardiac failure occurred in 0.5% of patients treated with CABOMETYX as a single agent, including fatal cardiac failure in 0.1% of patients. Consider baseline and periodic evaluations of left ventricular ejection fraction. Monitor for signs and symptoms of cardiovascular events. Withhold and resume at a reduced dose upon recovery or permanently discontinue depending on the severity.
Diarrhea: CABOMETYX can cause diarrhea and it occurred in 62% (10% Grade 3) of treated patients. Monitor and manage patients using antidiarrheals as indicated. Withhold CABOMETYX until improvement to ≤ Grade 1; resume at a reduced dose.
Palmar-Plantar Erythrodysesthesia (PPE): CABOMETYX can cause PPE and it occurred in 45% of treated patients (13% Grade 3). Withhold CABOMETYX until PPE resolves or decreases to Grade 1 and resume at a reduced dose for intolerable Grade 2 PPE or Grade 3 PPE.
Hepatotoxicity: CABOMETYX in combination with nivolumab in RCC can cause hepatic toxicity with higher frequencies of Grades 3 and 4 ALT and AST elevations compared to CABOMETYX alone. With the combination of CABOMETYX and nivolumab, Grades 3 and 4 increased ALT or AST were seen in 11% of patients. Monitor liver enzymes before initiation of treatment and periodically. Consider more frequent monitoring as compared to when the drugs are administered as single agents. Consider withholding CABOMETYX and/or nivolumab, initiating corticosteroid therapy, and/or permanently discontinuing the combination for severe or life-threatening hepatotoxicity.
Adrenal Insufficiency: CABOMETYX in combination with nivolumab can cause primary or secondary adrenal insufficiency. Adrenal insufficiency occurred in 4.7% (15/320) of patients with RCC who received CABOMETYX with nivolumab, including Grade 3 (2.2%), and Grade 2 (1.9%) adverse reactions. Withhold CABOMETYX and/or nivolumab and resume CABOMETYX at a reduced dose depending on severity.
Proteinuria: Proteinuria was observed in 8% of CABOMETYX patients. Monitor urine protein regularly during CABOMETYX treatment. For Grade 2 or 3 proteinuria, withhold CABOMETYX until improvement to ≤ Grade 1 proteinuria; resume CABOMETYX at a reduced dose. Discontinue CABOMETYX in patients who develop nephrotic syndrome.
Osteonecrosis of the Jaw (ONJ): CABOMETYX can cause ONJ and it occurred in <1% of treated patients. Perform an oral examination prior to CABOMETYX initiation and periodically during treatment. Advise patients regarding good oral hygiene practices. Withhold CABOMETYX for at least 3 weeks prior to scheduled dental surgery or invasive dental procedures. Withhold CABOMETYX for development of ONJ until complete resolution; resume at a reduced dose.
Impaired Wound Healing: CABOMETYX can cause impaired wound healing. Withhold CABOMETYX for at least 3 weeks prior to elective surgery. Do not administer for at least 2 weeks after major surgery and until adequate wound healing. The safety of resumption of CABOMETYX after resolution of wound healing complications has not been established.
Reversible Posterior Leukoencephalopathy Syndrome (RPLS): CABOMETYX can cause RPLS. Perform evaluation for RPLS and diagnose by characteristic finding on MRI any patient presenting with seizures, headache, visual disturbances, confusion, or altered mental function. Discontinue CABOMETYX in patients who develop RPLS.
Thyroid Dysfunction: CABOMETYX can cause thyroid dysfunction, primarily hypothyroidism, and it occurred in 19% of treated patients (0.4% Grade 3). Assess for signs of thyroid dysfunction prior to the initiation of CABOMETYX and monitor for signs and symptoms during treatment.
Hypocalcemia: CABOMETYX can cause hypocalcemia, with the highest incidence in DTC patients. Based on the safety population, hypocalcemia occurred in 13% of CABOMETYX patients (2% Grade 3 and 1% Grade 4).
Monitor blood calcium levels and replace calcium as necessary during treatment. Withhold and resume CABOMETYX at a reduced dose upon recovery or permanently discontinue CABOMETYX depending on severity.
Embryo-Fetal Toxicity: CABOMETYX can cause fetal harm. Advise pregnant women of the potential risk to a fetus and advise females of reproductive potential to use effective contraception during treatment with CABOMETYX and for 4 months after the last dose.
ADVERSE REACTIONS
The most common (≥20%) adverse reactions are:
CABOMETYX as a single agent: diarrhea, fatigue, PPE, decreased appetite, hypertension, nausea, vomiting, weight decreased, and constipation.
CABOMETYX in combination with nivolumab: diarrhea, fatigue, hepatotoxicity, PPE, stomatitis, rash, hypertension, hypothyroidism, musculoskeletal pain, decreased appetite, nausea, dysgeusia, abdominal pain, cough, and upper respiratory tract infection.
DRUG INTERACTIONS
Strong CYP3A4 Inhibitors: If coadministration with strong CYP3A4 inhibitors cannot be avoided, reduce the CABOMETYX dosage. Avoid grapefruit or grapefruit juice.
Strong or Moderate CYP3A4 Inducers: If coadministration with strong or moderate CYP3A4 inducers cannot be avoided, increase the CABOMETYX dosage. Avoid St. John’s wort.
USE IN SPECIFIC POPULATIONS
Lactation: Advise women not to breastfeed during CABOMETYX treatment and for 4 months after the final dose.
Hepatic Impairment: In patients with moderate hepatic impairment, reduce the CABOMETYX dosage. Avoid CABOMETYX in patients with severe hepatic impairment.
Pediatric Use: Physeal widening has been observed in children with open growth plates when treated with CABOMETYX. Physeal and longitudinal growth monitoring is recommended in children (12 years and older) with open growth plates. Consider interrupting or discontinuing CABOMETYX if abnormalities occur. The safety and effectiveness of CABOMETYX in pediatric patients less than 12 years of age have not been established.
Please see accompanying full Prescribing Information View Source
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About Zanzalintinib
Zanzalintinib is a novel oral kinase inhibitor that inhibits the activity of the TAM kinases (TYRO3, AXL, MER), MET and VEGF receptors. These kinases play important roles in oncogenic processes, including tumor cell proliferation, metastasis, angiogenesis, drug resistance and evasion of antitumor immunity. The zanzalintinib development program includes a series of ongoing and planned pivotal trials to explore its therapeutic potential in CRC, clear cell and non-clear cell RCC, and NET, as well as earlier-stage trials in meningioma, lung cancer and castration-resistant prostate cancer.
In February 2026, Exelixis announced that the U.S. Food and Drug Administration (FDA) accepted the company’s New Drug Application for zanzalintinib, in combination with atezolizumab (Tecentriq), for the treatment of adult patients with mCRC who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, and, if RAS wild-type, an anti-epidermal growth factor receptor (EGFR) therapy. The FDA assigned a Prescription Drug User Fee Act target action date of December 3, 2026.
Zanzalintinib is an investigational agent that is not approved for any use and is the subject of ongoing clinical trials.
(Press release, Exelixis, MAY 21, 2026, View Source [SID1234665946])