On May 27, 2026 Sarah Cannon Research Institute (SCRI), one of the world’s leading oncology research organizations conducting community-based clinical trials, reported it will present new data across more than 155 abstracts and presentations at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place in Chicago from May 29–June 2, 2026.

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The data reflect contributions from over 85 authors and coauthors across more than 30 research sites in SCRI’s network and include findings from both early- and late-phase clinical trials. These findings underscore SCRI’s role in advancing innovative therapies from first-in-human studies to practice-changing science leveraging the network’s scientific leadership and expansive community-based research footprint.

"The breadth of research presented by SCRI investigators at this year’s ASCO (Free ASCO Whitepaper) Annual Meeting reflects the unique role SCRI plays in cancer clinical research," said David R. Spigel, MD, President and Chief Medical Officer, SCRI. "Our work provides patients access to the best available research options and expert care in the communities where they live. Everyone facing cancer should have the opportunity to participate in trials with new agents without having to travel great distances away from their families and homes. We look forward to sharing our latest insights with the global oncology community in Chicago."

For a comprehensive list of SCRI abstracts and presentations, visit SCRI’s ASCO (Free ASCO Whitepaper) Site. To learn more about our research experts, visit the SCRI Leadership page.

Noteworthy Presentations

Blood Cancer & Blood Disorders

Hans Lee, MD, SCRI, will deliver "First Results from the Phase 1/2 LINKER-AL2 Trial of Linvoseltamab in Patients with Relapsed or Refractory Systemic Light Chain Amyloidosis" in an oral presentation on Friday, May 29 at 3:09 p.m. CDT during the session, Hematologic Malignancies—Plasma Cell Dyscrasia in S100a.
Peter Forsberg, MD, SCRI at Colorado Blood Cancer Institute, will present "Optec/Optal: A Phase 2 Study to Evaluate Outpatient, Step-Up Administration of Teclistamab or Talquetamab with Prophylactic Tocilizumab in Patients with Relapsed/Refractory Multiple Myeloma" in an oral presentation on Sunday, May 31 at 9:51 a.m. CDT during the session, Hematologic Malignancies—Plasma Cell Dyscrasia in E450a.
John Burke, MD, SCRI at Rocky Mountain Cancer Centers | The US Oncology Network, is coauthor on the Late Breaking Abstract, "frontMIND: Phase 3 Study of Tafasitamab plus Lenalidomide and R-CHOP for Patients with Newly Diagnosed Diffuse Large B-Cell Lymphoma" that will be presented on Saturday, May 30 at 3:00 p.m. CDT as part of the session, Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia in the Arie Crown Theater.
Breast Cancer

Erika Hamilton, MD, SCRI, will deliver "Efficacy and Safety of Tucatinib vs Placebo Combined with Trastuzumab and Pertuzumab as Maintenance Therapy for HER2+ Metastatic Breast Cancer by Stratified Subgroups" in an oral presentation on Tuesday, June 2 at 11:09 a.m. CDT as part of the session, Breast Cancer—Metastatic in Hall D1.
Mabel Mardones, MD, SCRI at Rocky Mountain Cancer Centers | The US Oncology Network, is a coauthor on the Late Breaking Abstract, "Giredestrant + Palbociclib vs Letrozole + PALBO as First-Line Therapy in Patients with Estrogen Receptor–Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer: Primary Analysis of the Phase III persevERA BC Trial" that will be presented on Tuesday, June 2 at 11:45 a.m. CDT during the session, Breast Cancer—Metastatic in Hall D1.
Lung Cancer

Melissa Johnson, MD, SCRI, is coauthor on the Late Breaking Abstract, "Event-Free Survival with Adjuvant Selpercatinib in Stage IB-IIIA RET Fusion-Positive NSCLC: Primary Results of the Phase 3 LIBRETTO-432 Trial" that will be presented during the Plenary Session on Sunday, May 31 at 2:13 p.m. CDT in Hall B1.
Melanoma & Skin Cancers

Meredith McKean, MD, MPH, SCRI, is coauthor on the Late Breaking Abstract, "Darovasertib Plus Crizotinib vs Investigator’s Choice as First-Line Treatment for Patients with HLA-A2 Negative Metastatic Uveal Melanoma: Primary Results from the OptimUM-02 Trial" that will be presented on Monday, June 1 at 9:00 a.m. CDT during the session, Melanoma/Skin Cancers in S100bc.
Additional

James Essell, MD, SCRI at OHC | The US Oncology Network, will deliver the oral "Impact of Remote Therapeutic Monitoring with Patient-Reported Outcomes on Hospitalization in Real-World Patients Receiving Therapy for Metastatic Solid Tumors" that will be presented on Sunday, May 31 at 9:24 a.m. CDT during the session, Quality Care/Health Services Research in S100bc.
Dr. Erika Hamilton and Elisa Fontana, MD, PhD, SCRI at HCA Healthcare UK, also serve on the ASCO (Free ASCO Whitepaper) Annual Meeting Scientific Program Committee; Dr. Hamilton as the Prior Annual Meeting Scientific Committee Chair and Dr. Fontana on the Gastrointestinal Cancer – Colorectal & Anal Committee.

In addition to scientific presentations, SCRI leadership will participate in and lead several ASCO (Free ASCO Whitepaper) sessions, including:

Stephen Strickland, Jr., MD, MSCI, SCRI, will offer the "Transplant Specialist Perspective" during the session, From Myelodysplastic Syndrome to Acute Myeloid Leukemia: Treatment-Related Myeloid Neoplasm Diagnosis and Therapeutic Strategies on Saturday, May 30 from 8:00 a.m. – 9:00 a.m. CDT in E450b.
Howard Burris, III, MD, SCRI, will deliver the "Top Donor Recognition Ceremony" during the Opening Session on Saturday, May 30 from 11:15 a.m. – 11:25 a.m. CDT in Hall B1.
Dr. Melissa Johnson will present "KRAS-Directed Therapy: A Clinical Update" during the ASCO (Free ASCO Whitepaper)/AACR Joint Session: The KRAS Journey – Perseverance Pays Off on Saturday, May 30 from 1:34 p.m. – 1:49 p.m. CDT in S100bc.
Debra Patt, MD, PhD, MBA, SCRI at Texas Oncology | The US Oncology Network, will present "Algorithms in Action: From Training to Practice" during the session, Oncology 2.0: How Artificial Intelligence Is Closing the Information Gap – Or Is It? on Sunday, May 31 from 10:45 a.m. – 10:57 a.m. CDT in S102.
Dr. Elisa Fontana will present "RAS in Colorectal Cancer: Mechanisms of Action, Inhibition and Resistance" during the session, Emerging and Established Targets in Colorectal Cancer: Translating Biology in Therapeutics, as well as moderate the panel Q&A, on Sunday, May 31 from 4:30 p.m. – 4:45 p.m. CDT in Hall D2.
Benjamin Garmezy, MD, SCRI, will chair the session, Rapid Oral: Genitourinary Cancer – Kidney and Bladder on Monday, June 1 at 8:00 a.m. – 9:30 a.m. CDT in Hall D2.
Dr. Erika Hamilton will serve as Chair for the session, Highlights of the Year II on Monday, June 1 at 8:00 a.m. – 9:15 a.m. CDT in Hall D1.
Dee Anna Smith, SCRI, will deliver "The Community Frontline: Scaling Rapid Activation for Real-World Impact" during the session, Time to Activation in Oncology Clinical Trials: Challenges and Opportunities for Improvement on Monday, June 1 from 8:40 a.m. – 8:55 a.m. CDT in S100a.
Additional SCRI First-Author Poster Presentations

Saturday, May 30, 2026

"Advancing Health Equity in Oncology: Virtual Collaborative Behavioral Health Engagement and Outcomes Among Medicaid-Insured and BIPOC Patients," Nina Balanchivadze, MD, SCRI at Virginia Oncology Associates | The US Oncology Network, 9:00 a.m. – 12:00 p.m. CDT, Hall A.
"Phase 1 Dose Escalation of CTX-8371, a Novel PD-1xPD-L1 Bispecific Antibody, in Patients with Advanced Malignancies Post Checkpoint Inhibition," Judy Wang, MD, SCRI at Florida Cancer Specialists & Research Institute | The US Oncology Network, 1:30 p.m. – 4:30 p.m. CDT, Hall A.
"BI-1808 + Pembrolizumab: Responses to a Chemotherapy-Free Regimen in Advanced Ovarian Cancer," Anja Williams, MD, SCRI at HCA Healthcare UK, 1:30 p.m. – 4:30 p.m. CDT, Hall A.
Sunday, May 31, 2026

"Real-World Characteristics, Homologous Recombination Repair Mutation Testing, Treatment Patterns, and Outcomes of Patients with Metastatic Castration-Sensitive Prostate Cancer in the US Community Oncology Setting," Manojkumar Bupathi, MD, MS, SCRI at Rocky Mountain Cancer Centers | The US Oncology Network, 9:00 a.m. – 12:00 p.m. CDT, Hall A.
"Combining HC-7366 with Belzutifan in Patients with Renal Cell Carcinoma to Alter Tumor and Microenvironment: Pharmacokinetic and Pharmacodynamic Analysis of a Phase 1b Study," Dr. Benjamin Garmezy, 9:00 a.m. – 12:00 p.m. CDT, Hall A.
"Imneskibart + Low-Dose Subcutaneous IL-2 ± Nivolumab in Patients with CPI-Refractory Cutaneous Melanoma: Promising Results from an Ongoing Phase 1/2 Study," Dr. Meredith McKean, 9:00 a.m. – 12:00 p.m. CDT, Hall A.
"Efficacy, Safety, and Cytokine Profiling with Addition of the Toll-Like Receptor 7/8 Dual Agonist EIK1001 to Standard of Care First-Line Therapy: The Phase 2 TeLuRide-005 Trial in Stage 4 NSCLC," Bo Wang, MD, SCRI at Willamette Valley Cancer Institute and Research Center | The US Oncology Network, 9:00 a.m. – 12:00 p.m. CDT, Hall A.
Monday, June 1, 2026

"Evaluating the Impact of a Statewide Intervention on Multiple Myeloma Bispecific T-Cell Engaging Antibody Therapy Uptake in Florida," Maen Hussein, MD, SCRI at Florida Cancer Specialists & Research Institute | The US Oncology Network, 9:00 a.m. – 12:00 p.m. CDT, Hall A.
"Comparative Efficacy of Linvoseltamab versus Teclistamab in Triple-Class Exposed Relapsed/Refractory Multiple Myeloma: Updated Matching-Adjusted Indirect Comparison with Longer Follow-Up," Dr. Hans Lee, 9:00 a.m. – 12:00 p.m. CDT, Hall A.
"Efficacy Prediction for Progression-Free Survival and Overall Survival by Genomic Instability Score Cutoffs in Patients with Advanced Ovarian Cancer: Post Hoc Results from the Phase 3 PRIMA/ENGOT-OV26/GOG-3012 Trial," Bradley Monk, MD, SCRI at Florida Cancer Specialists & Research Institute | The US Oncology Network, 9:00 a.m. – 12:00 p.m. CDT, Hall A.
"A Phase 1/2, First-in-Human Study of AVZO-021, a Selective Cyclin-Dependent Kinase 2 Inhibitor, as Monotherapy and in Combination for Patients with Advanced Solid Tumors, including Hormone Receptor–Positive/Human Epidermal Growth Factor Receptor 2–Negative Breast Cancer and Cyclin E1–Amplified Solid Tumors: Updated Safety and Efficacy Results," Manish R. Patel, MD, SCRI at Florida Cancer Specialists & Research Institute | The US Oncology Network, 1:30 p.m. – 4:30 p.m. CDT, Hall A.

(Press release, Sarah Cannon Research Institute, MAY 27, 2026, View Source [SID1234666123])

On May 27, 2026 Precigen, Inc. (Nasdaq: PGEN), a commercial-stage biopharmaceutical company specializing in the advancement of innovative precision medicines to improve the lives of patients, reported that the US Food and Drug Administration (FDA) has granted orphan drug exclusivity for PAPZIMEOS (zopapogene imadenovec-drba) for the treatment of adults with recurrent respiratory papillomatosis (RRP). PAPZIMEOS was granted full approval by the FDA in August 2025, becoming the first and only approved treatment for adults with RRP, a rare, chronic and debilitating disease. PAPZIMEOS is commercially available in the US and is being prescribed nationwide across both major medical centers and community practices, with patients spanning a range of disease severities actively receiving treatment.

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Orphan drug exclusivity is granted to certain drugs and biologics approved for rare diseases or conditions that affect fewer than 200,000 people in the United States. The orphan drug exclusivity granted by the FDA for PAPZIMEOS for the treatment of adults with RRP is effective through August 14, 2032, providing seven years of market exclusivity in the US from the PAPZIMEOS approval date.

"We appreciate the FDA’s recognition of seven years of orphan drug exclusivity for PAPZIMEOS, which is a testament to the groundbreaking pivotal study data and the transformative potential of PAPZIMEOS in addressing the root cause of this rare disease," said Helen Sabzevari, PhD, President and CEO of Precigen. "This regulatory exclusivity, together with Precigen’s patent portfolio covering PAPZIMEOS and its therapeutic use, enhances the product’s value by strengthening market protection and long-term revenue potential, which in turn supports continued innovation for rare diseases."

About RRP
RRP is a rare, debilitating, and potentially life-threatening disease of the upper and lower respiratory tract caused by chronic HPV 6 or HPV 11 infection. RRP can lead to severe voice disturbance, compromised airways, and recurrent post-obstructive pneumonia. Although rare, RRP has the potential for transformation to malignant cancer and can be fatal. Management of RRP has primarily consisted of repeated surgeries, which do not address the underlying cause of the disease and can be associated with significant morbidity as well as significant patient and health system burden. As the number of lifetime surgeries increases, the risk for irreversible iatrogenic laryngeal injury increases with each surgery, and patients may undergo hundreds of these surgeries over their lifetimes. RRP can impact patients’ work and social lives, financial stability, and mental health. Patients with RRP can experience substantial impacts to daily living with decreased quality of life and high health care utilization. Based on an internal analysis of claims data and electronic health records, there are approximately 27,000 adult RRP patients in the US.

About PAPZIMEOS (zopapogene imadenovec-drba), for subcutaneous injection only
PAPZIMEOS is the first and only FDA-approved therapy for the treatment of adults with RRP and the first and only approved therapy to address the root cause of RRP. PAPZIMEOS is a non-replicating adenoviral vector-based immunotherapy designed to express a fusion antigen comprising selected regions of human papillomavirus (HPV) types 6 and 11 proteins. PAPZIMEOS is designed to generate an immune response directed against HPV 6 and HPV 11 proteins in patients with RRP. Discovered and designed in Precigen’s labs using Precigen’s proprietary AdenoVerse therapeutic platform, PAPZIMEOS represents a new therapeutic paradigm for RRP.

Indication and Important Safety Information

What is PAPZIMEOS?
PAPZIMEOS is a type of immunotherapy used to treat a condition called recurrent respiratory papillomatosis (RRP) in adults.

What is the most important information I should know about PAPZIMEOS?
Some people may have a reaction to the shot. Signs and symptoms may include redness, pain, swelling, itching, or warmth where the shot was given. After your first treatment, your healthcare provider will watch you for at least 30 minutes to make sure you’re feeling okay.

Please contact your doctor immediately if you develop an infection, the reaction to your shot worsens, or you experience any of the below symptoms, which may indicate a systemic allergic reaction:

Difficulty breathing
Widespread rash
Facial swelling
Thrombotic events (blood clots that block your blood vessels) may occur after your PAPZIMEOS shot. Please notify your doctor immediately if you have the following symptoms:

Shortness of breath
Chest pain
Leg swelling
Persistent abdominal pain
Severe or persistent headaches
Blurred vision
What should I know before taking PAPZIMEOS?
Before taking PAPZIMEOS, tell your healthcare provider about all of your medical conditions, including:

If you are pregnant or plan to become pregnant because it is not known if PAPZIMEOS will harm the unborn baby.
If you are breastfeeding or plan to breastfeed. It is unknown if PAPZIMEOS is present in breast milk, or how it affects the breastfeeding child or milk production. Talk to your healthcare provider about the best way to feed your baby during treatment with PAPZIMEOS.
What are the most common side effects of PAPZIMEOS?
The most common side effects include:

Pain, redness, or swelling where the shot was given
Feeling tired
Chills
Fever
Muscle aches
Nausea (feeling sick)
Headache
Increased heart rate
Diarrhea
Vomiting
Sweating a lot
These are not all of the possible side effects of PAPZIMEOS. Call your healthcare provider for medical advice about side effects. 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. You may also report side effects to Precigen, Inc. at 1-855-PGE-NRRP (1-855-743-6777).

(Press release, Precigen, MAY 27, 2026, View Source [SID1234666108])

On May 27, 2026 Arima Genomics, Inc., a cancer diagnostics company bringing DNA sequence and structure together to advance cancer therapy selection, reported that it will present new data at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place May 29-June 2 in Chicago.

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The findings in the poster presentation demonstrate the value of Arima’s Hi-C sequencing-based approach to fusion and rearrangement detection, available clinically through the Aventa FusionPlus test, for identification of clinically actionable driver alterations in patients with non-small cell lung cancer (NSCLC).

Poster Presentation Details:

Poster Board Number: 420
Title: Hi-C Sequencing Can Identify Clinically Actionable Fusions in Non-Small Cell Lung Cancer Missed by Other Sequencing Technologies
Abstract Number: 8630
Date and Time: May 31, 2026, 9:00am-12:00pm CDT
Track: Lung Cancer-Non-Small Cell Metastatic
Presenter: Kevin Levine, M.D., University of Washington/Fred Hutchinson Cancer Center, Seattle, WA.

(Press release, Arima Genomics, MAY 27, 2026, View Source [SID1234666124])

On May 27, 2026 Bristol Myers Squibb (NYSE: BMY) reported that the company will participate in the Goldman Sachs 47th Annual Global Healthcare Conference on Tuesday, June 9, 2026.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The company will take part in a fireside chat beginning at 2:00 p.m. ET.

Investors and the general public are invited to listen to the session by visiting View Source An archived edition of the session will be available following its conclusion.

(Press release, Bristol-Myers Squibb, MAY 27, 2026, View Source [SID1234666093])

On May 27, 2026 BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, reported that data from HERIZON-GEA-01 were published in The New England Journal of Medicine and will be presented in an oral presentation (Rapid Oral Abstract: 4010) at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on June 1, 2026, in Chicago. The HERIZON-GEA-01 clinical trial evaluated ZIIHERA (zanidatamab) plus chemotherapy, with and without TEVIMBRA (tislelizumab), compared with the control arm of trastuzumab plus chemotherapy as first-line treatment for advanced/metastatic HER2+ gastroesophageal adenocarcinoma (GEA).

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Dr. Sun Young Rha, Professor of Medical Oncology at the Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, South Korea, senior author of the NEJM manuscript and first author of the ASCO (Free ASCO Whitepaper) abstract, said:

"Results from the HERIZON-GEA-01 published in The New England Journal of Medicine and presented in an oral presentation at ASCO (Free ASCO Whitepaper) provide new data about the regimen of tislelizumab added to zanidatamab plus chemotherapy, which demonstrated meaningfully improved outcomes for patients with HER2-positive gastroesophageal adenocarcinoma. In particular, the findings show that this regimen resulted in a survival benefit, even in patients with PD-L1 <1%. This combination has the potential to be an important new treatment option in areas of high unmet need in HER2+ GEA."

Key findings published in The New England Journal of Medicine

Overall survival (OS): A statistically significant and clinically meaningful improvement in OS with ZIIHERA plus TEVIMBRA and chemotherapy, reaching a median OS of 26.4 months; mOS of 24.4 months was reported with ZIIHERA plus chemotherapy, and 19.2 months with the control arm.
Progression-free survival (PFS): A statistically significant and clinically meaningful improvement in PFS in both ZIIHERA-containing arms with a median PFS of 12.4 months.
Duration of Response (DoR): Median DoR of 20.7 months with ZIIHERA and TEVIMBRA plus chemotherapy; median DoR of 14.3 months with ZIIHERA plus chemotherapy and 8.3 months with the control arm.
Dr. Geoffrey Ku, Associate Attending physician on the Gastrointestinal Oncology Service in the Department of Medicine at Memorial Sloan Kettering Cancer Center, author of the NEJM manuscript and the ASCO (Free ASCO Whitepaper) abstract, said:

"This practice-changing study demonstrates that zanidatamab is clearly superior to trastuzumab, with a manageable safety profile, in HER2-positive GEA. Moreover, the addition of tislelizumab contributes to the prolongation of overall survival and remarkable durability of responses, with benefit in both PD-L1 positive and negative tumors. If approved, the combination of zanidatamab, tislelizumab and chemotherapy should become the standard of care in untreated metastatic or locally advanced HER2-positive GEA patients irrespective of the tumor PD-L1 status."

Oral presentation with new data at ASCO (Free ASCO Whitepaper) 2026 demonstrates benefit regardless of PD-L1 status

With 26 months of follow-up, ZIIHERA plus TEVIMBRA and chemotherapy meaningfully improved PFS and OS were observed in both PD-L1-positive and PD-L1-negative patients compared with the control arm; data were consistent between tumor area positivity (TAP) and combined positive score (CPS).
In PD-L1 TAP <1% and ≥1% patients, the 18-month PFS was 50.3% and 42.6%, respectively, and the 24-month OS was 63.7% and 53.5% with ZIIHERA plus TEVIMBRA and chemotherapy.
In PD-L1-negative patients (TAP <1%), median OS was 29.7 months with ZIIHERA plus TEVIMBRA and chemotherapy compared with 15.8 months with the control arm. In PD-L1-positive patients (TAP≥1%), median OS was 26.4 months with ZIIHERA plus TEVIMBRA and chemotherapy compared with 21.2 months in the control arm. Findings were consistent across PD-L1 assessment methods.
In TAP<1%, the ZIIHERA plus TEVIMBRA and chemotherapy regimen resulted in a mPFS of 18.5 months compared with mPFS of 7.9 months in the control arm, while in TAP≥1% patients, the mPFS was 11.3 months vs. mPFS of 8.3 months in the control arm
Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors at BeOne Medicines, said:

"The HERIZON-GEA-01 results – now published in The New England Journal of Medicine with a detailed sub-group analysis presented in an oral session at ASCO (Free ASCO Whitepaper) – strengthen the evidence supporting the role of TEVIMBRA in driving a sustained and statistically significant overall survival benefit. With a median OS of more than 26 months, unprecedented in this disease, the TEVIMBRA-containing arm is positioned as a compelling new therapeutic approach in a disease where there remains a critical unmet need."

The safety findings for the ZIIHERA plus TEVIMBRA and chemotherapy arm were generally consistent with the known effects of HER2-directed therapy and immunotherapy, and no new safety signals were identified. Diarrhea was the most common Grade ≥3 treatment-related adverse event (TRAE) in 24.5% of patients with ZIIHERA plus TEVIMBRA and chemotherapy, 20.0% of patients in the ZIIHERA plus chemotherapy arm, and 12.9% in the trastuzumab plus chemotherapy arm, noting that the median treatment duration was longest for the triplet arm at 43.1 weeks (vs. 31.0 weeks with ZIIHERA plus chemotherapy and 30.0 weeks in the control arm). A mandatory anti-diarrheal prophylaxis was established during the first cycle, and discontinuation rates due to drug-related diarrhea were relatively low at 4.1%, 1.3%, and 0% of patients, respectively, with most diarrhea events occurring early in the trial.

Regulatory Status

The U.S. FDA has accepted a supplemental Biologics License Applications (sBLA) for TEVIMBRA and has granted it priority review. In addition, the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has accepted sBLAs for ZIIHERA and for TEVIMBRA for the first-line treatment of advanced/metastatic HER2+ GEA. BeOne holds the rights to ZIIHERA in Asia (excluding India and Japan), Australia, and New Zealand, and intends to work with authorities in these markets to expedite regulatory submissions.

About the HERIZON-GEA-01 Phase 3 Trial

HERIZON-GEA-01 (NCT05152147) is a global, randomized, open-label Phase 3 trial, conducted jointly with Jazz Pharmaceuticals, to evaluate and compare the efficacy and safety of ZIIHERA plus chemotherapy, with and without TEVIMBRA, to the standard of care (trastuzumab plus chemotherapy) as first-line treatment for adult patients with advanced/metastatic HER2+ GEA. The trial randomized 914 patients from approximately 300 trial sites in more than 30 countries. Patients for this trial had unresectable locally advanced, recurrent or metastatic HER2+ GEA (adenocarcinomas of the stomach or esophagus, including the gastroesophageal junction), defined as 3+ HER2 expression by IHC or 2+ HER2 expression by IHC with ISH positivity per central assessment. Patients were randomized to the three trial arms: ZIIHERA in combination with chemotherapy and TEVIMBRA; ZIIHERA in combination with chemotherapy; and trastuzumab plus chemotherapy. The trial is evaluating dual primary endpoints, PFS per blinded independent central review (BICR) and OS.

About Gastroesophageal Adenocarcinoma

Gastroesophageal adenocarcinoma (GEA), which includes cancers of the stomach, gastroesophageal junction, and esophagus, is the fifth most common cancer worldwide. Approximately 20% of GEA patients have HER2-positive disease.1,2,3, which has high morbidity and mortality, and patients are urgently in need of new treatment options. The overall prognosis for patients with GEA remains poor, with a global five-year survival rate of less than 30% for gastric cancer and about 19% for GEA.4

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.5

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

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

(Press release, BeOne Medicines, MAY 27, 2026, View Source [SID1234666109])