On May 21, 2026 BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, reported that more than 60 abstracts across hematologic malignancies and solid tumors have been accepted for presentation at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (May 29–June 2, Chicago) and the 2026 European Hematology Association (EHA) (Free EHA Whitepaper) Congress (June 11–14, Stockholm).

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Continuing to raise the bar in CLL

At ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) 2026, BeOne will showcase its hematology leadership with data spanning foundational therapies and next-generation innovation across CLL, mantle cell lymphoma and other B-cell malignancies. The data emphasize impressive long-term outcomes, durability across patient populations, and a disciplined approach to advancing future regimens. Collectively, these data underscore BeOne’s strategy to lead in hematology science and patient impact by setting the standard today – while helping to shape the future of CLL.

Amit Agarwal, M.D., Ph.D., Chief Medical Officer, Hematology, BeOne Medicines, said:

"Seventy-eight-month follow-up data from SEQUOIA underscore what it truly takes to lead in CLL over the long term: long-term efficacy, ability for sequencing treatments, and confidence in first-line treatment decisions. Building on that leadership, we’re excited to be rapidly advancing the next generation of medicines, including sonrotoclax-based combinations and our BTK degrader BGB-16673, which are designed to extend what is possible for patients across lines of therapy."

Key data presentations in CLL include:

New results from the SEQUOIA trial with 78 months follow-up reinforce BRUKINSA (zanubrutinib) as the foundational BTK inhibitor in CLL, with durable disease control that continues to raise expectations for what patients and physicians should expect from first-line therapy over the long term. Data will be presented at both ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper).
A subgroup analysis of SEQUOIA, which includes one of the largest and longest-followed cohorts of patients aged ≥80 years ever reported in a Phase 3 CLL study, showing that age did not limit benefit. Data will be presented at EHA (Free EHA Whitepaper) 2026.
Oral presentation at EHA (Free EHA Whitepaper) 2026 of updated data of BeOne’s foundational BTK degrader – BGB-16673 – in patients with R/R CLL, demonstrating promising and durable activity and a manageable safety profile. An additional poster will be shared featuring never-before-presented data of BGB-16673 in BTK-naïve patients. BGB-16673 is the most advanced BTK degrader in the clinic, with more than 1,100 patients dosed.
Data from the all-oral combination of BeOne’s foundational BCL2 inhibitor sonrotoclax plus zanubrutinib (ZS) in CLL, which demonstrated deep responses, unprecedented speed to undetectable MRD, and durable remissions and a generally well-tolerated safety profile. These data reinforce the potential for a next-generation, time-limited approach designed to deliver long-term outcomes without compromising durability or safety. Data will be presented as a poster at ASCO (Free ASCO Whitepaper) 2026 and an oral presentation at EHA (Free EHA Whitepaper) 2026.
Accelerating a high-potential solid tumor portfolio

BeOne is highlighting strong momentum across its deep and diverse solid tumor portfolio at ASCO (Free ASCO Whitepaper), with seven unique assets featured in three oral presentations and eight posters. These data span both in-line and pipeline therapies, including results demonstrating the differentiated profile of PD-1 inhibitor TEVIMBRA (tislelizumab) across lung and gastrointestinal cancers, as well as in combination with the novel HER2-targeting agent ZIIHERA (zanidatamab). The Company’s development superhighway is accelerating progress across all stages of development, generating compelling clinical data that support the potential of these therapies to reshape treatment in areas of high unmet need.

Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors, BeOne Medicines, said:

"At ASCO (Free ASCO Whitepaper) 2026, we are demonstrating the strength of BeOne’s science, the scale of our pipeline, and the speed at which we are delivering innovation for patients. With multiple programs moving simultaneously toward pivotal trials, we are building durable disease leadership across breast, gynecologic, lung and gastrointestinal cancers – areas where substantial unmet patient need remains."

Key data presentations across our solid tumor programs include:

First disclosure of anti-tumor effects and safety/tolerability profile of the highly selective CDK4 inhibitor BGB-43395 Phase 1 treatment data in first-line HR-positive/HER2-negative breast cancer.
Rapid oral presentation on BG-C9074, a promising B7-H4-targeting ADC, with Phase 1 dose escalation and safety expansion data.
Rapid oral presentation on BGB-B2033, a potentially first-in-class GPC3 x 4-1BB bispecific antibody, with first clinical data of a Phase 1 study in heavily pre-treated hepatocellular carcinoma patients.
Rapid oral presentation with a PD-L1 subgroup analysis of the HERIZON-GEA-01 trial in which TEVIMBRA in combination with ZIIHERA and chemotherapy demonstrated a statistically significant improvement in overall survival (OS) and progression-free survival (PFS) in patients with HER2+ gastroesophageal adenocarcinoma, irrespective of PD-L1 expression (in partnership with Jazz Pharmaceuticals).
Investor webcast to highlight pipeline data at ASCO (Free ASCO Whitepaper)

BeOne will host an investor webcast on June 1, 2026, at 7:00 PM CDT/8:00 PM EDT, led by John V. Oyler, Co-Founder, Chairman, and CEO, alongside the Company’s leadership team and invited key opinion leaders. The webcast will review clinical and corporate highlights from ASCO (Free ASCO Whitepaper), provide updates on BeOne’s global R&D pipeline and platforms, and discuss the strategic priorities and execution capabilities driving the Company’s long-term growth.

Webcast access details are available in the Investors section of BeOne’s website at View Source, View Source, and View Source An archived webcast will be available on the Company’s website.

Full list of BeOne’s presentations at ASCO (Free ASCO Whitepaper):

Hematology

BRUKINSA (Zanubrutinib)

Abstract Title

Presentation Details

Lead Author

Subsequent therapies and time to second progression-free survival events in treatment-naive chronic lymphocytic leukemia/small lymphocytic lymphoma previously treated with zanubrutinib or bendamustine-rituximab in SEQUOIA

Poster Presentation: 544

Session Title: Poster Session – Hematologic Malignancies – Lymphoma and Chronic Lymphocytic Leukemia

Session Date/Time: June 1, 2026, 9:00 AM-12:00 PM CDT

Constantine S. Tam

Navigating the post–covalent Bruton tyrosine kinase inhibitor landscape in mantle cell lymphoma: Real-world insights on treatment patterns, discontinuation, and healthcare resource utilization

Poster Presentation: 556

Session Title: Poster Session – Hematologic Malignancies – Lymphoma and Chronic Lymphocytic Leukemia

Session Date/Time: June 1, 2026, 9:00 AM-12:00 PM CDT

Alvaro Alencar

Real-world outcomes among Medicare beneficiaries treated with first-line Bruton tyrosine kinase inhibitors for chronic lymphocytic leukemia

Poster Presentation: 545

Session Title: Poster Session – Hematologic Malignancies – Lymphoma and Chronic Lymphocytic Leukemia

Session Date/Time: June 1, 2026, 9:00 AM-12:00 PM CDT

Daniel A. Ermann

Real-world impact of atrial fibrillation on cardiovascular outcomes and healthcare resource utilization in patients with chronic lymphocytic leukemia

Poster Presentation: 540

Session Title: Poster Session – Hematologic Malignancies – Lymphoma and Chronic Lymphocytic Leukemia

Session Date/Time: June 1, 2026, 9:00 AM-12:00 PM CDT

Michael Fradley

Real-world treatment survival outcomes for zanubrutinib and acalabrutinib monotherapy among treatment-naïve patients with chronic lymphocytic leukemia in the United States

Poster Presentation: 543

Session Title: Poster Session – Hematologic Malignancies – Lymphoma and Chronic Lymphocytic Leukemia

Session Date/Time: June 1, 2026, 9:00 AM-12:00 PM CDT

Ryan Jacobs

A real-world comparison of treatment and survival outcomes with zanubrutinib and acalabrutinib monotherapy among patients with relapsed or refractory mantle cell lymphoma in the United States

Poster Presentation: 560

Session Title: Poster Session – Hematologic Malignancies – Lymphoma and Chronic Lymphocytic Leukemia

Session Date/Time: June 1, 2026, 9:00 AM-12:00 PM CDT

Yucai Wang

Incidence of cardiac-related deaths among patients aged ≥65 years with B-cell malignancies treated with ibrutinib

Abstract Number: e19020

Ryan Jacobs

Risk factors for second primary malignancies in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma: A real-world study

Abstract Number: e19022

Lili Zhou

Characterizing patient self-reported adherence to BTKis and symptoms in CLL/SLL using an electronic patient-reported outcomes platform

Abstract Number: e19030

Mustafa Ascha

Real-world treatment utilization, sequencing patterns, and healthcare resource utilization in Waldenström macroglobulinemia

Abstract Number: e19056

Jorge Castillo

Sonrotoclax

Abstract Title

Presentation Details

Lead Author

First-line treatment of CLL/SLL with the all-oral combination of sonrotoclax and zanubrutinib achieves undetectable minimal residual disease rates of >90%, including in patients with del(17p)/TP53

Poster Presentation: 541

Session Title: Poster Session – Hematologic Malignancies – Lymphoma and Chronic Lymphocytic Leukemia

Session Date/Time: June 1, 2026, 9:00 AM-12:00 PM CDT

Constantine S. Tam

Sonrotoclax + zanubrutinib vs venetoclax + acalabrutinib in treatment-naive chronic lymphocytic leukemia: A phase 3 randomized trial design (CELESTIAL-TNCLL-2)

Poster Presentation: 596a

Session Title: Poster Session – Hematologic Malignancies – Lymphoma and Chronic Lymphocytic Leukemia

Session Date/Time: June 1, 2026, 9:00 AM-12:00 PM CDT

Mazyar Shadman

Efficacy of sonrotoclax vs pirtobrutinib in post–Bruton tyrosine kinase inhibitor relapsed/refractory mantle cell lymphoma: An indirect comparison

Abstract Number: e19050

Alvaro Alencar

Solid Tumors

BGB-43395 (CDK4i)

Abstract Title

Presentation Details

Lead Author

First disclosure of frontline treatment with the selective CDK4 inhibitor BGB-43395 in combination with letrozole for metastatic HR+/HER2− breast cancer: A phase 1 safety expansion

Poster Session: 180

Session Title: Poster Session – Breast Cancer – Metastatic

Session Date/Time: June 1, 2026, 1:30-4:30 PM CDT

Shom Goel

BG-C9074 (B7-H4-targeting ADC)

Abstract Title

Presentation Details

Lead Author

First-in-human study of BG-C9074 (B7-H4–targeting ADC) in advanced solid tumors: Dose escalation and safety expansion

Rapid Oral Abstract: 3013

Session Title: Rapid Oral Abstract Session – Developmental Therapeutics – Molecularly Targeted Agents and Tumor Biology

Session Date/Time: June 2, 2026, 9:45-11:15 AM CDT

Binghe Xu

Consideration of adjusted ideal body weight dosing in BG-C9074 (B7-H4-targeting ADC) from pharmacokinetics, efficacy and safety perspectives

Poster Session: 166

Session Title: Poster Session – Developmental Therapeutics – Molecularly Targeted Agents and Tumor Biology

Session Date/Time: May 30, 2026, 1:30-4:30 PM CDT

Hugh Giovinazzo

BGB-B2033 (GPC3x4-1BB bispecific antibody)

Abstract Title

Presentation Details

Lead Author

A phase 1 study of BGB-B2033 (GPC3 x 4-1BB bispecific antibody) monotherapy in patients with selected advanced or metastatic solid tumors: First disclosure of clinical data

Rapid Oral Abstract: 3016

Session Title: Rapid Oral Abstract Session – Developmental Therapeutics – Molecularly Targeted Agents and Tumor Biology

Session Date/Time: June 2, 2026, 9:45-11:15 AM CDT

Hong Jae Chon

TEVIMBRA (tislelizumab) and ZIIHERA (zanidatamab)

Abstract Title

Presentation Details

Lead Author

Zanidatamab + chemotherapy ± tislelizumab for first-line HER2-positive locally advanced or metastatic gastroesophageal adenocarcinoma: PD-L1 subgroup analysis from HERIZON-GEA-01

Rapid Oral Abstract: 4010

Session Title: Rapid Oral Abstract
Session – Gastrointestinal
Cancer-Gastroesophageal,
Pancreatic, and Hepatobiliary

Session Date/Time: June 1, 2026, 1:15-2:45 PM CDT

SunYoung Rha

Characterization and management of gastrointestinal adverse events with zanidatamab + chemotherapy ± tislelizumab in first-line HER2-positive locally advanced or metastatic gastroesophageal adenocarcinoma: Analysis from HERIZON-GEA-01

Poster Presentation: 25

Session Title: Poster Session –

Gastrointestinal Cancer-

Gastroesophageal, Pancreatic,

and Hepatobiliary

Session Date/Time: May 30, 2026, 9
AM-12:00 PM CDT

Elena Elimova

TEVIMBRA (tislelizumab)

Abstract Title

Presentation Details

Lead Author

RATIONALE-315: Post hoc analysis of event-free survival by surgically relevant subgroups treated with perioperative tislelizumab and neoadjuvant chemotherapy vs neoadjuvant chemotherapy

Poster Presentation: 533

Session Title: Poster Session – Lung Cancer – Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers

Session Date/Time: May 31, 2026, 9:00 AM-12:00 PM CDT

Gustavo Schvartsman

Quality-adjusted survival comparison for tislelizumab + chemotherapy (CT) versus placebo + CT as first-line treatment in gastric/gastroesophageal junction adenocarcinoma patients with peritoneal metastasis: Long-term follow-up from RATIONALE-305

Poster Presentation: 17

Session Title: Poster Session – Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary

Session Date/Time: May 30, 2026, 9:00 AM-12:00 PM CDT

Rutika Mehta

A novel Bayesian approach for assessing associations between ECOG performance status and patient-reported outcomes in patients with gastric or gastroesophageal junction adenocarcinoma: Post hoc analysis from the RATIONALE-305 trial

Abstract Number: e16044

Marcia Cruz-Correa

Ociperlimab

Abstract Title

Presentation Details

Lead Author

Exploratory biomarker analysis of ociperlimab plus tislelizumab in patients with PD-L1-positive non-small cell lung cancer in AdvanTIG-105

Poster Session: 361

Session Title: Poster Session – Developmental Therapeutics – Immunotherapy

Session Date/Time: May 30, 2026, 1:30-4:30 PM CDT

Jun Zhang

BGB-A3055 (anti-CCR8)

Abstract Title

Presentation Details

Lead Author

A phase 1 study of BGB-A3055 (anti-CCR8) with or without tislelizumab (anti-PD-1) in patients with solid tumors

Poster Session: 313

Session Title: Poster Session – Developmental Therapeutics – Immunotherapy

Session Date/Time: May 30, 2026, 1:30 PM-4:30 PM CDT

Judith Raimbourg

Full list of BeOne’s presentations at EHA (Free EHA Whitepaper):

Zanubrutinib

Abstract Title

Presentation Details

Lead Author

Long-term follow-up for safety and efficacy of zanubrutinib in elderly (≥80 years) treatment naïve CLL/SLL patients, including those with del(17p): Subgroup analysis from the SEQUOIA trial

Publication Number: PS1703

Session: Poster Session 2

Session Date/Time: June 13, 2026, 6:45-7:45 PM CEST

Alessandra Tedeschi

Subsequent therapies and time to second progression-free survival events in chronic lymphocytic leukemia/small lymphocytic lymphoma previously treated with zanubrutinib or bendamustine-rituximab

Publication Number: PF601

Session: Poster Session 1

Session Date/Time: June 12, 2026, 6:45-7:45 PM CEST

Mazyar Shadman

Zanubrutinib vs ibrutinib in treatment-naive chronic lymphocytic leukemia (CLL): Implications for interpreting fixed-duration treatment outcomes from CLL17

Publication Number: PS1718

Session: Poster Session 2

Session Date/Time: June 13, 2026, 6:45-7:45 PM CEST

Talha Munir

Associations between ECOG performance status and patient-reported outcomes in relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma: Post hoc analysis from the ALPINE trial

Publication Number: PS2492

Session: Poster Session 2

Session Date/Time: June 13, 2026, 6:45-7:45 PM CEST

Nicole Lamanna

A longitudinal analysis of patients with CLL/SLL with impaired health-related quality of life scores at baseline who were treated with zanubrutinib versus ibrutinib: A post hoc analysis of ALPINE

Publication Number: PF1398

Session: Poster Session 1

Session Date/Time: June 12, 2026, 6:45-7:45 PM CEST

Loic Ysebaert

Real-world zanubrutinib treatment patterns in CLL/SLL among US community oncology patients with prior acalabrutinib therapy

Publication Number: PF618

Session: Poster Session 1

Session Date/Time: June 12, 2026, 6:45-7:45 PM CEST

Jing-Zhou Hou

Patterns of treatment utilization and sequencing across lines of therapy in Waldenström macroglobulinemia: Real-world evidence from the United States

Publication Number: PS2516

Session: Poster Session 2

Session Date/Time: June 13, 2026, 6:45-7:45 PM CEST

Prashant Kapoor

Real-world comparative analysis of treatment discontinuation with covalent Bruton tyrosine kinase inhibitors in first-line chronic lymphocytic leukemia

Publication Number: PS1710

Session: Poster Session 2

Session Date/Time: June 13, 2026, 6:45-7:45 PM CEST

Nakhle Saba

Real-world treatment and survival outcomes for zanubrutinib and acalabrutinib monotherapy among treatment-naïve patients with chronic lymphocytic leukemia in the United States

Publication Number: PF608

Session: Poster Session 1

Session Date/Time: June 12, 2026, 6:45-7:45 PM CEST

Ryan Jacobs

A real-world comparison of treatment and survival outcomes with zanubrutinib and acalabrutinib monotherapy among patients with relapsed or refractory mantle cell lymphoma in the United States

Publication Number: PS2040

Session: Poster Session 2

Session Date/Time: June 13, 2026, 6:45-7:45 PM CEST

Yucai Wang

Clinical outcomes among patients with relapsed/refractory mantle cell lymphoma receiving zanubrutinib or acalabrutinib in real-world practice in the United States

Publication Number: PF958

Session: Poster Session 1

Session Date/Time: June 12, 2026, 6:45-7:45 PM CEST

Javier Munoz

Real-world impact of atrial fibrillation on cardiovascular outcomes and healthcare resource utilization in patients with chronic lymphocytic leukemia

Publication Number: PS2515

Session: Poster Session 2

Session Date/Time: June 13, 2026, 6:45-7:45 PM CEST

Rhys Williams

Treatment burden among patients aged 75 or older with chronic lymphocytic leukemia and small lymphocytic lymphoma

Publication Number: PF605

Session: Poster Session 1

Session Date/Time: June 12, 2026, 6:45-7:45 PM CEST

Daniel Ermann

Real-world effectiveness and safety of zanubrutinib in Waldenström macroglobulinemia: Results from the Belgian WIZARD study

Abstract Number: PB3600

Willem Daneels

Real-world experience with zanubrutinib in chronic lymphocytic leukaemia – patient profile, treatment patterns, and safety: Preliminary analysis of French ROZALY study

Abstract Number: PB2898

Florian Bouclet

BRUMIZE: Real-world zanubrutinib use and preliminary safety in R/R marginal zone lymphoma in Europe

Abstract Number: PB3632

Côme Bommier

Indirect comparison of zanubrutinib vs acalabrutinib and ibrutinib efficacy in patients with treatment-naïve chronic lymphocytic leukemia

Abstract Number: PB2895

Mazyar Shadman

Patient-reported outcomes and disease progression in chronic lymphocytic leukemia and small lymphocytic lymphoma: A systematic literature review and gap analysis

Abstract Number: PB2909

Loic Ysebaert

Understanding patients’ perspectives and preferences regarding first-line chronic lymphocytic leukemia treatment across Europe

Abstract Number: PB2934

Lydia Scarfò

Number of deaths avoided with use of zanubrutinib versus ibrutinib for the treatment of chronic lymphocytic leukemia in Europe

Abstract Number: PB2944

Talha Munir

Real-world intravenous immunoglobulin utilization in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma treated with venetoclax plus obinutuzumab vs zanubrutinib

Abstract Number: PB2915

Nicole Lamanna

Real-world outcomes among Medicare beneficiaries treated with first-line Bruton tyrosine kinase inhibitors for chronic lymphocytic leukemia

Abstract Number: PB2901

Daniel A. Ermann

Exploring the patient and hematologist preference of treatment characteristics for chronic lymphocytic leukemia: A qualitative study in Europe

Abstract Number: PB4474

Lydia Scarfò

Sonrotoclax

Abstract Title

Presentation Details

Lead Author

First-line treatment of CLL/SLL with the all-oral combination of sonrotoclax and zanubrutinib achieves undetectable minimal residual disease rates of >90%, including in patients with del(17p)/TP53

Publication Number: S145

Session: s424 Prognostication and first line therapy in CLL

Session Date/Time: June 12, 2026

17:15 – 18:30 CEST

Chan Y. Cheah

Updated safety and efficacy of all-oral sonrotoclax + zanubrutinib in relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma, including patients with del(17p)/TP53

Publication Number: PS1697

Session: Poster Session 2

Session Date/Time: June 13, 2026, 6:45-7:45 PM CEST

Stephen S. Opat

Combination treatment with novel BCL2 inhibitor sonrotoclax (BGB-11417) and zanubrutinib in patients with relapsed/refractory mantle cell lymphoma: Results from a phase 1/1b study

Publication Number: PF933

Session: Poster Session 1

Session Date/Time: June 12, 2026, 6:45-7:45 PM CEST

Jacob D. Soumerai

Phase 1/2 study of sonrotoclax (BGB-11417) monotherapy in Bruton tyrosine kinase inhibitor–pretreated relapsed/refractory mantle cell lymphoma: A Chinese subpopulation analysis

Publication Number: PF961

Session: Poster Session 1

Session Date/Time: June 12, 2026, 6:45-7:45 PM CEST

Yuqin Song

Sonrotoclax (BGB-11417) + zanubrutinib vs venetoclax + acalabrutinib in treatment-naive chronic lymphocytic leukemia: A phase 3 randomized trial design (CELESTIAL-TNCLL-2)

Abstract Number: PB2966

Mazyar Shadman

Efficacy of sonrotoclax versus pirtobrutinib in post–Bruton tyrosine kinase inhibitor relapsed/refractory mantle cell lymphoma: An indirect comparison

Abstract Number: PB3626

Toby A. Eyre

Navigating the post–covalent Bruton tyrosine kinase inhibitor landscape in mantle cell lymphoma: Real-world insights on treatment patterns, discontinuation, and healthcare resource utilization

Abstract Number: PB3617

Toby A. Eyre

Risk of tumor lysis syndrome among venetoclax-treated patients with chronic lymphocytic leukemia or mantle cell lymphoma: A real-world study

Abstract Number: PB2896

Alessandra Ferrajoli

BGB-16673

Abstract Title

Presentation Details

Lead Author

BGB-16673, a Bruton tyrosine kinase degrader, in patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma: A phase 1 CaDAnCe-101 study update

Publication Number: S152

Session: s449 Novel therapies in relapsed/refractory CLL

Session Date/Time: June 14, 2026

11:00 – 12:15 CEST

Stephan Stilgenbauer

Bruton tyrosine kinase (BTK) degrader BGB-16673 in BTK inhibitor–naive patients with CLL/SLL and other B-cell malignancies: Results from the phase 1 CaDAnCe-101 study

Publication Number: PS1693

Session: Poster Session 2

Session Date/Time: June 13, 2026, 6:45-7:45 PM CEST

Irina Mocanu

BGB-16673, a Bruton tyrosine kinase degrader, in patients with relapsed/refractory Waldenström macroglobulinemia: A phase 1 CaDAnCe-101 study update

Publication Number: PS2033

Session: Poster Session 2

Session Date/Time: June 13, 2026, 6:45-7:45 PM CEST

Judith Trotman

BGB-16673, a Bruton tyrosine kinase degrader, has low risk of CYP3A-mediated drug-drug interaction (DDI): Phase 1 absorption, distribution, metabolism, and excretion and DDI study results

Publication Number: PS1711

Session: Poster Session 2

Session Date/Time: June 13, 2026, 6:45-7:45 PM CEST

Judith Trotman

BGB-16673 versus idelalisib + rituximab (R), bendamustine + R, or venetoclax + R re-treatment in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma: The phase 3 CaDAnCe-302 trial

Abstract Number: PB2925

Paolo Ghia

Tislelizumab

Abstract Title

Presentation Details

Lead Author

Evaluation of PET-CT metrics and pharmacokinetics in adults receiving tislelizumab for relapsed/refractory classical Hodgkin lymphoma: Ancillary analyses of LYSA phase 2 TIRHOL study BGB-A317-210

Publication Number: PS2028

Session: Poster Session 2

Session Date/Time: June 13, 2026, 6:45-7:45 PM CEST

Hervé Ghesquières

About BRUKINSA (zanubrutinib)

BRUKINSA is an orally available, small molecule inhibitor of Bruton’s tyrosine kinase (BTK) designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared with other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease-relevant tissues.

With the broadest label globally, BRUKINSA is the foundational BTK inhibitor. It is also the only BTK inhibitor to provide the flexibility of once or twice daily dosing and the only BTK inhibitor to demonstrate superiority to another BTK inhibitor in a Phase 3 study.

The global BRUKINSA clinical development program includes more than 8,000 patients enrolled in over 30 countries and regions across more than 45 trials. BRUKINSA is approved in 80 markets in at least one indication, and more than 290,000 patients have been treated globally.

About BEQALZI (sonrotoclax)

BEQALZI (sonrotoclax) is a foundational, next-generation and potentially best-in-class B-cell lymphoma 2 (BCL2) inhibitor with a unique pharmacokinetic and pharmacodynamic profile. Preclinical and clinical studies in early drug development have shown that sonrotoclax is a highly potent and specific BCL2 inhibitor with a short half-life and no drug accumulation. BEQALZI has shown promising clinical activity across a range of B-cell malignancies, including chronic lymphocytic leukemia (CLL), and is in development as a monotherapy and in combination with other therapeutics, including zanubrutinib. To date, more than 2,200 patients have been enrolled across the broad sonrotoclax global development program.

About BGB-16673

BGB-16673 is a foundational and potential first-in-class and best-in-class Bruton’s tyrosine kinase (BTK) degrader for the treatment of B-cell malignancies. With 1,100+ patients dosed to date in an extensive global clinical development program, BGB-16673 is the most advanced BTK degrader in the clinic. This program includes three randomized Phase 3 trials in R/R CLL, including the head-to-head Phase 3 trial versus pirtobrutinib, which began enrolling in Q4 2025. Originating from BeOne’s chimeric degradation activation compound (CDAC) platform, BGB-16673 is designed to promote the degradation, or breakdown, of both wildtype and mutant forms of BTK, including those that commonly result in resistance to BTK inhibitors in patients who experience progressive disease.

The U.S. Food and Drug Administration (FDA) granted Fast Track Designation to BGB-16673 for the treatment of adult patients with relapsed or refractory (R/R) chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL), and adult patients with R/R mantle cell lymphoma (MCL). Additionally, the European Medicines Agency (EMA) granted BGB-16673 PRIority MEdicines (PRIME) designation for the treatment of patients with Waldenstrom’s macroglobulinemia (WM) previously treated with a BTK inhibitor.

About ZIIHERA (zanidatamab)

ZIIHERA (zanidatamab) is a bispecific human epidermal growth factor receptor 2, or HER2-directed antibody that binds to two extracellular sites on HER2. Binding of zanidatamab with HER2 results in internalization leading to a reduction in HER2 expression of the receptor on the tumor cell surface. Zanidatamab induces complement-dependent cytotoxicity (CDC), antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP). These mechanisms result in tumor growth inhibition and cell death in vitro and in vivo.1

Zanidatamab is being developed in multiple clinical trials as a targeted treatment option for patients with solid tumors that express HER2. Zanidatamab is approved in China for the treatment of patients who have unresectable, locally advanced, or metastatic HER2-high expression (IHC 3+) biliary tract cancer (BTC) and who have received prior systemic therapy. ZIIHERA has also been granted accelerated approval in the U.S. and conditional marketing authorization in the European Union for eligible BTC patients. Zanidatamab is being developed by Jazz and BeOne under license agreements from Zymeworks, which first developed the molecule. BeOne has licensed zanidatamab from Zymeworks in Asia (excluding India and Japan), Australia and New Zealand. Jazz Pharmaceuticals has rights in all other regions.

ZIIHERA is a registered trademark of Zymeworks BC Inc.

About TEVIMBRA (tislelizumab)

TEVIMBRA is a uniquely designed humanized immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD-1) monoclonal antibody with high affinity and binding specificity against PD-1. It is designed to minimize binding to Fc-gamma (Fcγ) receptors on macrophages, helping to aid the body’s immune cells to detect and fight tumors.

TEVIMBRA is the foundational asset of BeOne’s solid tumor portfolio and has shown potential across multiple tumor types and disease settings. The global TEVIMBRA clinical development program includes almost 15,000 patients enrolled to date in 30+ countries and regions across 71 trials, including 21 registration-enabling studies. TEVIMBRA is approved in over 50 countries, and more than 2 million patients have been treated globally.

Select Important Safety Information for BRUKINSA (zanubrutinib)

Serious adverse reactions, including fatal events, have occurred with BRUKINSA, including hemorrhage, infections, cytopenias, second primary malignancies, cardiac arrhythmias, and hepatotoxicity (including drug-induced liver injury).

In the pooled safety population (N=1729), the most common adverse reactions (≥30%), including laboratory abnormalities, in patients who received BRUKINSA were neutrophil count decreased (51%), platelet count decreased (41%), upper respiratory tract infection (38%), hemorrhage (32%), and musculoskeletal pain (31%).

Please see full U.S. Prescribing Information including U.S. Patient Information.

Select Important Safety Information for BEQALZITM (sonrotoclax)

Serious and sometimes fatal adverse reactions have occurred with BEQALZI, including tumor lysis syndrome (TLS), serious infections, neutropenia, and embryo-fetal toxicity. BEQALZI is contraindicated with strong CYP3A inhibitors at initiation and during the ramp-up phase due to the potential for an increased risk of tumor lysis syndrome.

In the safety population (N=115), tumor lysis syndrome occurred in 7% of patients who followed the recommended dose ramp-up. Serious infections occurred in 14% of patients, and Grade 3 or 4 infections occurred in 17% (fatal: 2.6%), with pneumonia (10%) being the most common Grade 3 or greater infection. Grade 3 or 4 decreases in neutrophils occurred in 18% of patients (Grade 4: 6%), and febrile neutropenia occurred in 1.7% of all patients. The most common adverse reactions (≥15%) were pneumonia (16%) and fatigue (16%). The most common Grade 3–4 laboratory abnormalities (≥15%) were decreases in lymphocytes (29%) and neutrophils (18%).

Please see full Prescribing Information.

Select Important Safety Information for TEVIMBRA

Serious and sometimes fatal adverse reactions occurred with TEVIMBRA treatment. Warnings and precautions include severe and fatal immune-mediated adverse reactions, including pneumonitis, colitis, hepatitis, endocrinopathies, dermatologic adverse reactions, nephritis with renal dysfunction, and solid organ transplant rejection. Other warnings and precautions include infusion-related reactions, complications of allogeneic HSCT, and embryo-fetal toxicity.

Please see full U.S. Prescribing Information including the U.S. Medication Guide.

The information provided in this press release is intended for a global audience. Product indications vary by region.

(Press release, BeOne Medicines, MAY 21, 2026, View Source [SID1234665950])

On May 21, 2026 Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology innovation, reported the first disclosure of Phase 2 data from the C-800-23 study evaluating botensilimab (BOT), Agenus’ multifunctional Fc-enhanced anti-CTLA-4 antibody, with balstilimab (BAL), an anti-PD-1 antibody, in patients with advanced cutaneous melanoma refractory or resistant to prior anti-PD-(L)1 therapy, including patients previously treated with anti-CTLA-4 therapy. The full dataset will be presented by Dr. Michael Atkins on May 31, 2026 at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago.

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The BOT+BAL combination arm included 36 heavily pretreated patients with advanced cutaneous melanoma. Most had disease that had resisted prior checkpoint therapy, and many had poor-risk features, including visceral disease and elevated LDH. In this setting, where patients have often exhausted the benefit of currently available checkpoint approaches, the most meaningful signals were the durability of benefit and survival outcomes observed with BOT+BAL.

In the overall BOT+BAL population, median overall survival was 16.6 months, 42% of patients were alive at two years, and median duration of response was not reached. Among responders, 86% remained in response at 12 months. Confirmed objective response rate was 22%, providing evidence of antitumor activity in a population where durable disease control is difficult to achieve.

Survival and durability were particularly notable in the subgroup of patients whose disease was refractory or resistant to both prior anti-PD-(L)1 and anti-CTLA-4 therapy. Published benchmarks show median overall survival of approximately 13 to 14 months among patients refractory or resistant to both anti-PD-(L)1 and anti-CTLA-4 therapyi,ii. In this dual checkpoint-exposed subgroup, median overall survival was not reached and 64% of patients were alive at two years. Median duration of response was also not reached, with all responders remaining in response at 12 months.

"Patients with advanced melanoma whose disease has progressed after PD-1-based therapy, particularly those also exposed to CTLA-4 therapy, remain difficult to treat. For those without a BRAF mutation, who lack an effective targeted option, the choices after checkpoint therapy are especially limited," said Michael B. Atkins, M.D., Deputy Director, Georgetown Lombardi Comprehensive Cancer Center, and lead author of the presentation. "In that setting, the survival and the durability of response seen with BOT plus BAL stand out, because sustained disease control is exactly what these patients rarely achieve."

"Melanoma has been one of the clearest examples of the transformative potential of immunotherapy, but patients whose disease progresses after PD-1 and CTLA-4 therapy continue to face limited options," said Steven O’Day, M.D., Chief Medical Officer of Agenus. "These findings add to the growing body of evidence supporting BOT plus BAL’s potential to drive meaningful and durable immune responses in tumors that have resisted prior checkpoint approaches. Importantly, the melanoma data are consistent with the durable activity previously reported with BOT plus BAL across other difficult-to-treat and historically immunotherapy-resistant solid tumors, including recent HCC data in a heavily prior IO-treated population."

Safety findings were consistent with the known safety profile of CTLA-4 and PD-1 checkpoint inhibition. In the BOT+BAL combination arm, grade 3 or higher treatment-related adverse events occurred in 36% of patients, with no treatment-related deaths reported. No new safety signals were observed.

The melanoma findings add to previously reported BOT+BAL activity across difficult-to-treat and historically immunotherapy-resistant solid tumors, including recently published data in Liver Cancer evaluating BOT+BAL in heavily immunotherapy-pretreated hepatocellular carcinoma.

"These data reinforce our conviction in BOT+BAL as a mechanistically differentiated CTLA-4-based combination designed to extend the benefit of immunotherapy to patients and tumor types not adequately served by current checkpoint approaches," said Garo Armen, Ph.D., Chairman and Chief Executive Officer of Agenus. "Across melanoma, colorectal cancer and other difficult-to-treat solid tumors, we continue to see a consistent pattern: durable responses and encouraging long-term survival in settings where available options remain limited. That is the foundation of our development strategy and the reason we remain focused on advancing BOT+BAL with urgency."

Key Phase 2 BOT+BAL Melanoma Findings

The Phase 2 C-800-23 study (NCT05529316) evaluated BOT+BAL in patients with advanced cutaneous melanoma refractory or resistant to prior anti-PD-(L)1 therapy, including patients previously treated with anti-CTLA-4 therapy. The intent-to-treat population included 36 patients treated with BOT 75 mg plus BAL 450 mg every three weeks.

Overall BOT+BAL population, N=36:

Median overall survival: 16.6 months
2-year overall survival rate: 42%
Median duration of response: not reached
12-month duration of response rate: 86%
Confirmed objective response rate: 22%
Clinical benefit rate at 24 weeks: 33%
Prior anti-PD-(L)1 plus anti-CTLA-4 refractory/resistant cohort, n=14:

Median overall survival: not reached
2-year overall survival rate: 64%
Median duration of response: not reached
12-month duration of response rate: 100%
Confirmed objective response rate: 29%
Clinical benefit rate at 24 weeks: 36%
Following the poster session on May 31, 2026, the full poster will be available on the Publications page of the Agenus website.

Presentation Details

Abstract Title: Botensilimab (BOT) ± balstilimab (BAL) in patients (pts) with advanced cutaneous melanoma (cMEL) refractory/resistant (R/R) to anti–PD-(L)1 ± CTLA-4: A phase 2 trial
Abstract No.: 9543

Presenter: Michael B. Atkins M.D.; Georgetown Lombardi Comprehensive Cancer Center, Georgetown University Medical Center
Session Title: Poster Session – Melanoma/Skin Cancers
Location: Hall A – Posters and Exhibits
Poster Board: 259
Date/Time: May 31, 2026, 9:00 AM–12:00 PM CDT
About the C-800-23 Phase 2 Melanoma Study

C-800-23 (NCT05529316) is an open-label, global Phase 2 trial evaluating botensilimab with or without balstilimab in patients with advanced cutaneous melanoma refractory or resistant to prior anti-PD-(L)1 therapy, with or without prior anti-CTLA-4 therapy.

The primary endpoint is confirmed objective response rate by RECIST 1.1. Secondary endpoints include duration of response, progression-free survival, overall survival, safety and tolerability. Clinical benefit rate, defined as complete response, partial response or stable disease at 24 weeks or later, was evaluated as an exploratory endpoint.

(Press release, Agenus, MAY 21, 2026, View Source [SID1234665949])

On May 21, 2026 Gilead Sciences, Inc. (Nasdaq: GILD) reported the successful completion of its previously announced acquisition of Tubulis GmbH, a private Germany-based, clinical-stage biotechnology company developing next-generation antibody-drug conjugates (ADCs).

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The acquisition brings Gilead next-generation ADC assets and a platform designed to maximize patient benefit through more selective delivery of diverse payloads to tumors. Tubulis’ technologies enable the development of unique ADCs with superior biophysical properties, capable of achieving robust on-tumor payload exposure that can translate to long-lasting anti-tumor activity. The addition of Tubulis’ lead asset, TUB-040, a NaPi2b-directed topoisomerase-I inhibitor (TOPO1i) ADC, which has demonstrated promising activity in platinum-resistant ovarian cancer, and TUB-030, a 5T4-directed ADC that is being investigated across various solid tumor types, complements Gilead’s existing ADC portfolio.

"We look forward to welcoming the Tubulis team to Gilead and building on the significant progress they have made in advancing novel ADC technology for people living with cancer," said Daniel O’Day, Chairman and Chief Executive Officer, Gilead Sciences. "Our two-year collaboration with Tubulis gave us strong conviction in their team, their programs and their technologies. We will now combine our strengths in service of providing new options for some of the most challenging forms of disease."

Under the terms of the agreement, Gilead acquired all the outstanding equity of Tubulis for $3.15 billion in upfront considerations on a cash-free, debt-free basis, and up to $1.85 billion in contingent milestone payments. The Tubulis team will continue to be based in Munich, Germany, establishing The Tubulis ADC Innovation Center. This new Center will be a hub for the team to continue building on its integrated discovery, manufacturing and clinical capabilities to advance next generation ADCs.

About TUB-040 and the Tubutecan Technology

TUB-040 is an investigational antibody-drug conjugate (ADC) that targets NaPi2b, a protein expressed at high levels in several tumor types, including ovarian, lung, and endometrial cancer. TUB-040 utilizes the Tubutecan technology engineered to have eight chemotherapy payloads (topoisomerase-I inhibitor) attached to a stable, cleavable linker system that allows for potent tumor cell killing. This design allows TUB-040 to deliver the drug directly to cancer cells while limiting exposure to healthy tissue, improving the tolerability of the ADC compared to earlier ADC technologies. In early clinical studies, TUB-040 has shown encouraging anti-tumor activity with a manageable safety profile in patients with platinum-resistant ovarian cancer, as reported at ESMO (Free ESMO Whitepaper) 2025. It is currently being evaluated in an ongoing multicenter Phase I/IIa study in patients with platinum-resistant ovarian cancer and relapsed or refractory non-small cell lung cancer.

(Press release, Gilead Sciences, MAY 21, 2026, View Source [SID1234665948])

On May 21, 2026 Orion Pharma (Orion Corporation) reported that for the first time it will present clinical data from the ongoing Phase 1/2 TEADES trial evaluating ODM-212, an investigational oral small-molecule pan-TEAD inhibitor, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place May 29 – June 2, 2026, in Chicago, USA.

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The TEADES study is a multi-center, open-label, first-in-human trial designed to evaluate the safety, tolerability and preliminary anti-tumour activity of ODM-212 in patients with advanced solid tumours, including tumour types characterized by dysregulation of the Hippo pathway, such as mesothelioma and epithelioid hemangioendothelioma (EHE).

Details of the presentation are as follows:

Title: First-in-human trial of the TEAD inhibitor ODM-212 in patients with advanced solid tumours (TEADES)
Session: Developmental Therapeutics – Molecularly Targeted Agents and Tumor Biology (Hall A)
Abstract number: 3111
Presentation date/time: May 30, 2026, 1:30 – 4:30 PM CDT
Data from the phase 1 study will be presented during the conference.

"The upcoming presentation at ASCO (Free ASCO Whitepaper) marks an important milestone for ODM-212, our clinical-stage TEAD inhibitor," says professor Outi Vaarala, Executive Vice President, Research & Development, Orion Pharma. "We look forward to sharing initial data from the TEADES study, which will inform the ongoing development of ODM-212 for patients with advanced solid tumours with high unmet medical need."

About the TEADES study
The TEADES trial is a Phase 1/2 multi-center, open-label study that will enroll up to 300 patients with MPM, EHE or other solid tumours with dysfunction of the Hippo pathway. The trial includes patients who have progressed despite available standard treatmentsand with limited further treatment options. The primary endpoints of the study are safety and tolerability with secondary endpoints including Overall Response Rate, Progression Free Survival and Overall Survival. This is a global trial conducted at leading oncology centers in the US and Europe.

About ODM-212
ODM-212 is an oral small-molecule pan-TEAD (Transcriptional Enhanced Associate Domain) inhibitor developed by Orion Pharma. It targets the Hippo signaling pathway, which regulates cell growth and organ size. Dysregulation of this pathway,particularly through YAP/TAZ activation,can lead to uncontrolled tumour growth and resistance to cancer therapies. ODM-212 works by blocking TEAD transcription factors, disrupting YAP-TEAD protein-protein interactions, and inhibiting TEAD auto-palmitoylation, which is essential for TEAD activity.

(Press release, Orion, MAY 21, 2026, View Source [SID1234665947])

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

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.

(Press release, Exelixis, MAY 21, 2026, View Source [SID1234665946])