On May 21, 2026 Mabwell (688062.SH, 02493.HK), an innovation-driven biopharmaceutical company with a fully integrated industry chain, reported it will present multiple clinical study results of its novel Nectin-4-targeting ADC 9MW2821 (Bulumtatug Fuvedotin, BFv) at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, including the Phase Ib/II clinical study data of 9MW2821 in combination with toripalimab for locally advanced or metastatic urothelial carcinoma (la/mUC) in the form of oral presentation, and the Phase II clinical study data of 9MW2821 in combination with toripalimab for perioperative muscle-invasive bladder cancer (MIBC) in the form of poster presentation.

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The Phase Ib/II clinical study of 9MW2821 in combination with toripalimab for the treatment of patients with la/mUC enrolled a total of 52 patients with advanced urothelial carcinoma. Follow-up results showed that as of December 1, 2025, 47 subjects were included in the efficacy analysis. The overall objective response rate (ORR) was 83.0%, confirmed ORR was 74.5%, complete response (CR) rate was 12.8%, and disease control rate (DCR) was 89.4%; and for the previously untreated populations, ORR was 87.5%, confirmed ORR was 80.0%, CR rate was 12.5% and DCR was 92.5%. The median progression-free survival (PFS) was 12.9 months, median duration of response (DoR) and median overall survival (OS) was not yet reached. No new safety signals related to 9MW2821 or toripalimab were observed in this study.

The Phase II clinical study on 9MW2821 in combination with toripalimab for patients with perioperative MIBC enrolled a total of 32 subjects. As of January 4, 2026, 7 subjects completed neoadjuvant therapy (9MW2821 in combination with toripalimab). Among these subjects, 6 subjects completed radical cystectomy and regional lymph node dissection, and 1 subject refused radical surgery due to achieving clinical CR following neoadjuvant therapy. Pathological complete response (pCR) was 66.7% (4/6), and pathological downstaging (pDS) rate was 83.3% (5/6). No new safety signals related to 9MW2821 or toripalimab were observed in this study.

About 9MW2821

9MW2821 is a novel Nectin-4-targeting ADC independently developed by Mabwell based on its ADC development platform. Mabwell is currently conducting multiple clinical studies for several indications including urothelial carcinoma, cervical cancer, esophageal cancer and breast cancer. It is the world’s first Nectin-4 ADC to enter Phase III clinical trials for cervical cancer (CC) and triple-negative breast cancer (TNBC). Four pivotal Phase III clinical studies are underway. 9MW2821 has obtained FDA Fast Track Designation for three indications, Orphan Drug Designation for one indication, and Breakthrough Therapy Designation from the CDE of NMPA for two indications.

Interim analysis for the Phase III clinical trials of urothelial carcinoma (UC) monotherapy, UC combination therapy and CC monotherapy are planned to be conducted in 2026, and Applications for pre-NDA meetings are expected to be submitted to the Center for Drug Evaluation under the National Medical Products Administration based on the data of interim analysis. Phase Ib/II clinical trial of CC combination therapy is planned to be completed in the second half of 2026, followed by a Phase III clinical trial to be initiated.

(Press release, Mabwell Biotech, MAY 21, 2026, View Source [SID1234665953])

On May 21, 2026 AstraZeneca reported its ambition to eliminate cancer as a cause of death and transform outcomes for people living with rare diseases with new data across its diverse, industry-leading portfolio and pipeline at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, 29 May to 2 June 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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More than 85 abstracts will feature 10 approved and 13 potential new medicines from the Company, including 25 oral presentations. Highlights include:

EMERALD-3: Phase III trial of Imfinzi (durvalumab) in combination with Imjudo (tremelimumab), with or without lenvatinib, and transarterial chemoembolisation (TACE) in patients with unresectable hepatocellular carcinoma (HCC) eligible for embolisation (Oral Abstract #LBA4000).
CARES: Phase III clinical programme of anselamimab, a potential first-in-class anti-fibril therapy from Alexion, AstraZeneca Rare Disease, in newly diagnosed patients with light chain (AL) amyloidosis receiving standard of care for underlying plasma cell dyscrasia, including results from a prespecified subgroup analysis based on involved kappa (κ) or lambda (λ) free light chain (Oral Abstract #7501).
SERENA-6: Final progression-free survival 2 (PFS2) results and circulating tumour DNA (ctDNA) clearance data linked to longer-term efficacy outcomes from the SERENA-6 Phase III trial of camizestrant in combination with widely approved cyclin-dependent kinase (CDK) 4/6 inhibitors in the 1st-line treatment of patients with hormone receptor (HR)-positive, HER2-negative advanced breast cancer whose tumours have an emergent ESR1 mutation (Oral Abstract #LBA1007).
BLUESTAR: Updated safety and efficacy results from the BLUESTAR Ph I/IIa trial of the B7-H4-directed ADC puxitatug samrotecan (Puxi-Sam) in patients with relapsed/metastatic B7-H4-positive endometrial and ovarian cancer who progressed on prior standard-of-care therapy (Rapid Oral Abstract #5515). Puxi-Sam was recently granted Breakthrough Therapy Designation by the US Food and Drug Administration (FDA) in this setting.
PRIMAVERA: Safety and preliminary efficacy from the first-in-human Phase I PRIMAVERA trial of the protein arginine methyltransferase 5 (PRMT5) inhibitor AZD3470 as monotherapy in relapsed/refractory classic Hodgkin lymphoma (Oral Abstract #7003).
Phase I initial results for NT-175 T-cell receptor therapy in TP53 R175H-mutated unresectable, advanced and/or metastatic solid tumours including pancreatic adenocarcinoma (Oral Abstract #2506).
TROPION-Breast02: Additional efficacy endpoints from the TROPION-Breast02 Phase III trial of Datroway (datopotamab deruxtecan) as 1st-line treatment for patients with locally recurrent inoperable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitors (Oral Abstract #1002).
DESTINY-Breast09: Exploratory analysis of treatment duration and clinical outcomes by complete response, partial response or stable/progressive disease in the DESTINY-Breast09 Phase III trial of Enhertu in combination with pertuzumab for the 1st-line treatment of patients with HER2-positive metastatic breast cancer (Rapid Oral Abstract #1021).
POTOMAC: Five-year overall survival and patient-reported outcomes from the Phase III POTOMAC trial of Imfinzi plus Bacillus Calmette-Guérin (BCG) induction and maintenance therapy in patients with high-risk non-muscle-invasive bladder cancer (Rapid Oral Abstract #4624).
Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: "The data at ASCO (Free ASCO Whitepaper) for our innovative medicines and next-wave assets further our strategy to redefine patient outcomes by taking novel combinations into earlier stages of disease and advancing new modalities. New data for Enhertu, Datroway and camizestrant reinforce their transformational potential in breast cancer. We’re also excited to share first clinical data for our T-cell receptor therapy, NT-175, and our PRMT5 inhibitor, AZD3470, as well as updated data for our most advanced in-house antibody drug conjugate, Puxi-Sam, which was recently granted Breakthrough Therapy Designation by the FDA. Collectively, these datasets underscore the strength and depth of our oncology pipeline."

Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca, said: "The EMERALD-3 data for Imfinzi and Imjudo in early liver cancer exemplify our successful strategy to move immunotherapy regimens into earlier stages of cancer where we can further improve outcomes for patients. With more than a dozen different indications approved across five cancer medicines in the last six months alone, we are reaching more patients with our growing portfolio, underscoring both the quality of our innovation and the strength of our business."

Gianluca Pirozzi, Head of Development, Regulatory and Safety, Alexion, said: "Results from the CARES Phase III clinical programme highlight the pioneering potential of anselamimab as a first-in-class, anti-fibril therapy for patients with kappa light chain amyloidosis. Its novel mechanism of action is designed to target and deplete amyloid deposits in affected organs, with potential to extend survival and reduce cardiovascular hospitalisations."

AstraZeneca is collaborating with Daiichi Sankyo to develop and commercialise Enhertu and Datroway.

Key AstraZeneca presentations during ASCO (Free ASCO Whitepaper) 20261

Lead Author

Abstract Title

Presentation details (CDT)

Antibody drug conjugates

Loi, S

Trastuzumab deruxtecan (T-DXd) + durvalumab (D) in patients (pts) with previously untreated HER2+ unresectable/metastatic breast cancer (mBC): Final analysis from DESTINY-Breast07.

Abstract #1012

Clinical Science Symposium

31 May 2026

09:18

Cescon, DW

First-line datopotamab deruxtecan (Dato-DXd) vs chemotherapy in patients with locally recurrent inoperable or metastatic triple-negative breast cancer (TNBC) for who immunotherapy was not an option: Additional efficacy endpoints from the TROPION-Breast02 study.

Abstract #1002

Oral Abstract Session

2 June 2026

10:09

Mileshkin, LR

Updated safety and efficacy of puxitatug samrotecan (Puxi-Sam, AZD8205) in patients (pts) with endometrial cancer (EC) or ovarian cancer (OC): Phase 1/2a BLUESTAR study.

Abstract #5515

Rapid Oral Abstract Session

30 May 2026

09:00

Park, YH

A DESTINY-Breast09 analysis of treatment duration and clinical outcomes by best response to trastuzumab deruxtecan (T-DXd) + pertuzumab (P).

Abstract #1021

Rapid Oral Abstract Session

31 May 2026

12:42

Untch, M

Secondary safety analysis of trastuzumab deruxtecan (T-DXd) vs trastuzumab emtansine (T-DM1) in DESTINY-Breast05: Clinical and demographic risk factors of interstitial lung disease (ILD) and radiation pneumonitis (RP).

Abstract #516

Rapid Oral Abstract Session

1 June 2026

10:57

Shitara, K

Sonesitatug vedotin (Sone-Ve) monotherapy in patients (pts) with claudin 18.2–positive (CLDN18.2+) advanced or metastatic gastric or gastroesophageal junction (GEJ) cancers: Data from CLARITY-PanTumor01.

Abstract #4023

Poster Session

30 May 2026

09:00

Janjigian, Y

First-line (1L) trastuzumab deruxtecan (T-DXd)–based regimens in advanced HER2-expressing gastric cancer (GC), gastroesophageal junction adenocarcinoma (GEJA), or esophageal adenocarcinoma (EA): Safety results from DESTINY-Gastric03 (DG-03) Part 2 arms D and F, and Part 4.

Abstract #4022

Poster Session

30 May 2026

09:00

Zhang, Y

Trastuzumab deruxtecan (T-DXd) for pretreated patients in China with HER2 IHC 3+ solid tumors: DESTINY-PanTumor03 Part 1 primary analysis.

Abstract #3026

Poster Session

30 May 2026

13:30

Immuno-oncology

Abou-Alfa, GK

Efficacy and safety results from EMERALD-3: A phase 3, randomized study of tremelimumab plus durvalumab with or without lenvatinib combined with transarterial chemoembolization (TACE) in participants (pts) with unresectable embolization-eligible hepatocellular carcinoma (eeHCC).

Abstract #LBA4000

Oral Abstract Session

1 June 2026

09:45

Skoulidis, F

Tremelimumab (T) + durvalumab (D) + chemotherapy (CT) vs pembrolizumab (P) + CT in 1L non-squamous (NSQ) metastatic NSCLC (mNSCLC) with STK11, KEAP1, and/or KRAS mutations (mut): Interim analysis (IA) of the phase 2b TRITON study.

Abstract #8515

Rapid Oral Abstract Session

30 May 2026

13:45

Heymach, JV

Impact of neoadjuvant durvalumab (D) on tumor microenvironment (TME) features and their association with event-free survival (EFS) in patients with resectable NSCLC (R-NSCLC) from the phase 3 AEGEAN trial.

Abstract #8015

Rapid Oral Abstract Session

31 May 2026

17:30

De Santis, M

Durvalumab (D) in combination with BCG induction and maintenance (I + M) therapy for BCG-naive, high-risk non–muscle-invasive bladder cancer (NMIBC): 5-year overall survival (OS) analysis and patient-reported outcomes (PROs) from POTOMAC.

Abstract #4624

Rapid Oral Abstract Session

1 June 2026

08:12

IO Bispecifics

O’Sullivan, CC

Neoadjuvant rilvegostomig (R) + trastuzumab deruxtecan (T-DXd) in high-risk HER2-negative breast cancer: Results from the I-SPY 2.2 trial.

Abstract #LBA514

Rapid Oral Abstract Session

1 June 2026

10:45

Zhou, J

First-line rilvegostomig (R) + chemotherapy (CTx) in advanced biliary tract cancer (BTC): Updated analysis of GEMINI-Hepatobiliary substudy 2 cohort A.

Abstract #88

Poster Session

30 May 2026

09:00

Guo, Y

Volrustomig monotherapy for recurrent/metastatic HNSCC: Substudy 2 of the eVOLVE-02 phase 2 study.

Abstract #482

Poster Session

30 May 2026

13:30

Tumour drivers and resistance

Wang, Z

Osimertinib with/without chemotherapy in patients with persistent ctDNA EGFR mutant (EGFRm) NSCLC at 3 weeks after 1L osimertinib: A randomized phase II study (FLAME study).

Abstract #LBA101

Clinical Science Symposium

30 May 2026

08:40

Bidard, FC

First-line (1L) camizestrant (CAMI) for emergent ESR1 mutations (ESR1m) in advanced breast cancer (ABC): Final progression-free survival 2 (PFS2) from the phase III SERENA-6 trial.

Abstract #LBA1007

Oral Abstract Session

2 June 2026

11:57

Peng, Z

A phase 2 pivotal study of savolitinib in patients with MET-amplified gastric cancer or gastroesophageal junction adenocarcinomas.

Abstract #4011

Rapid Oral Abstract Session

1 June 2026

13:27

Cell Therapy

Surana, R

Initial phase 1 study results of NT-175 engineered T-cell therapy in TP53 R175H–mutated unresectable advanced solid tumors.

Abstract #2506

Oral Abstract Session

31 May 2026

10:00

Epigenetics

Derenzini, E

A phase 1 study of the PRMT5 inhibitor AZD3470 in patients with relapsed/refractory classic Hodgkin lymphoma (PRIMAVERA).

Abstract #7003

Oral Abstract Session

30 May 2026

16:00

Rare Disease

Wechalekar, AD

Phase 3 randomized trial to evaluate the impact of anselamimab on all-cause mortality in κ light chain amyloidosis.

Abstract #7501

Oral Abstract Session

29 May 2026

14:57

Chen, AP

Final analysis of KOMET (NCT04924608), a phase 3 study of selumetinib in adults with NF1-PN.

Abstract #3110

Poster Session

30 May 2026

13:30

More than 85 abstracts at ASCO (Free ASCO Whitepaper) 2026 will feature AstraZeneca medicines and pipeline molecules

(Press release, AstraZeneca, MAY 21, 2026, View Source [SID1234665951])

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])