Exelixis Announces Presentations at ASCO 2026 Highlighting Ongoing Studies in Diverse Tumor Types

Key Terms

phase 3 medical

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

pivotal trial medical

A pivotal trial is a key test of a new medicine or treatment to see if it works and is safe enough to be approved by health authorities. It's like a final exam for a new product, and passing it is essential for bringing the treatment to the public.

metastatic colorectal cancer medical

Metastatic colorectal cancer is cancer that started in the colon or rectum and has spread to other parts of the body, most often the liver or lungs, making it harder to treat. For investors, it matters because advanced disease drives demand for more intensive treatments, ongoing clinical trials, and long-term care costs; think of it like a fire that has jumped from one room to multiple rooms, requiring bigger, more expensive responses and creating larger market opportunities and regulatory scrutiny.

neoadjuvant medical

"Neoadjuvant" describes treatments or interventions that are given before the main or primary procedure, such as surgery or a major decision. It’s like preparing the ground before planting seeds, aiming to improve the final outcome. For investors, understanding neoadjuvant approaches can provide insight into how companies enhance results or effectiveness in their processes or products.

immune checkpoint inhibitors medical

Drugs that release the immune system’s natural “brakes,” allowing immune cells to recognize and attack cancer cells; imagine taking the safety off a guard dog so it can chase intruders. They matter to investors because they can become high-value treatments with large sales potential, but their commercial success depends on clinical trial results, regulatory approval, competition and side-effect management, which all affect a company’s valuation.

randomized trial medical

A randomized trial is a study where participants are assigned by chance—like flipping a coin—to different treatments or to a comparison group so the results reflect the effect of the treatment rather than other factors. Investors care because these trials provide the most reliable evidence about whether a drug, device, or strategy works, and strong, clear results can change a company’s approval prospects, market size and risk profile quickly.

maintenance therapy medical

Treatment given after an initial successful response to control a chronic or recurring disease and prevent it from returning or worsening; it often involves lower-intensity, ongoing medication or interventions rather than aggressive cures. For investors, maintenance therapy matters because it can create steady, long-term demand for drugs or services, similar to a subscription that generates predictable revenue and extends a product’s commercial life beyond the initial treatment period.

urothelial cancer medical

Urothelial cancer is a type of cancer that starts in the thin inner lining of the urinary tract — most commonly the bladder, but also the ureters, renal pelvis and urethra. It matters to investors because the size of the patient population, unmet medical needs, and success or failure of diagnostic tests and treatments drive clinical trial outcomes, regulatory approvals, pricing and market opportunity for companies developing therapies or diagnostics; think of it as a distinct market segment in oncology.

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– Findings in neuroendocrine tumors, kidney cancer, advanced colorectal cancer and other tumors to be presented –

ALAMEDA, Calif.--(BUSINESS WIRE)-- Exelixis, Inc. (Nasdaq: EXEL) today announced presentations for its flagship product, CABOMETYX^® (cabozantinib), and its investigational oral kinase inhibitor, zanzalintinib, at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting to be held from May 29 – June 2 in Chicago.

“The presentations at ASCO 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 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 https://www.cabometyx.com/downloads/CABOMETYXUSPI.pdf.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.

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.

About Exelixis
Exelixis is a globally ambitious oncology company innovating next-generation medicines and regimens at the forefront of cancer care. Powered by drug discovery and development excellence, we are rapidly evolving our product portfolio to target an expanding range of tumor types and indications with our clinically differentiated pipeline of small molecules and biotherapeutics. This comprehensive approach harnesses decades of robust investment in our science and partnerships to advance our pipeline of franchise molecules, including our novel oral kinase inhibitor zanzalintinib, and to extend the impact of our flagship commercial product, CABOMETYX^® (cabozantinib). Exelixis is driven by a bold scientific pursuit to create transformational treatments that give more patients hope for the future. For information about the company and its mission to help cancer patients recover stronger and live longer, visit www.exelixis.com, follow @ExelixisInc on X (Twitter), like Exelixis, Inc. on Facebook and follow Exelixis on LinkedIn.

Forward-Looking Statements
This press release contains forward-looking statements, including, without limitation, statements related to: Exelixis’ planned presentations for cabozantinib and zanzalintinib, including new analyses from the phase 3 CABINET and STELLAR-303 trials, at the 2026 ASCO Annual Meeting; Exelixis’ strategy to build upon the well-established therapeutic profile of CABOMETYX and accelerate the development of zanzalintinib, its next oncology franchise molecule; Exelixis’ dedication to improving the standards of care for patients with cancer; and Exelixis’ scientific pursuit to create transformational treatments that give more patients hope for the future. 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 availability of data at the referenced times; complexities and the unpredictability of the regulatory review and approval processes in the U.S. and elsewhere; Exelixis’ continuing compliance with applicable legal and regulatory requirements; the potential failure of cabozantinib or zanzalintinib to demonstrate safety and/or efficacy in clinical trials; unexpected concerns that may arise as a result of the occurrence of adverse safety events or additional data analyses of clinical trials evaluating cabozantinib or zanzalintinib; the costs of conducting clinical trials; Exelixis’ dependence on third-party vendors for the development, manufacture and supply of cabozantinib and zanzalintinib; Exelixis’ ability to protect its intellectual property rights; market competition, including the potential for competitors to obtain approval for generic versions of Exelixis’ marketed products; changes in economic and business conditions; and other factors affecting Exelixis and its development programs detailed from time to time under the caption “Risk Factors” in Exelixis’ most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q, and in Exelixis’ future filings with the Securities and Exchange Commission. All forward-looking statements in this press release are based on information available to Exelixis as of the date of this press release, and Exelixis undertakes no obligation to update or revise any forward-looking statements contained herein, except as required by law.

Exelixis, the Exelixis logo and CABOMETYX are registered U.S. trademarks of Exelixis.

TECENTRIQ is a registered U.S. trademark of Genentech, a member of the Roche Group.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260521232880/en/

Investors Contact:
Andrew Peters
SVP, Strategy and Investor Relations
Exelixis, Inc.
650-837-7248
apeters@exelixis.com

Media Contact:
Lindsay Treadway
Vice President, Public Affairs and Advocacy Relations
Exelixis, Inc.
734-674-3180
ltreadway@exelixis.com

Source: Exelixis, Inc.