On November 4, 2026 Genmab A/S (Nasdaq: GMAB) reported that 22 abstracts evaluating epcoritamab, a subcutaneous T-cell engaging bispecific antibody, will be presented or published at the 68th Annual Meeting and Exposition of the American Society of Hematology (ASH) (Free ASH Whitepaper), taking place December 12-15, 2026, in New Orleans, Louisiana, and virtually.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

The breadth of data to be shared at ASH (Free ASH Whitepaper) reflects continued progress across the comprehensive epcoritamab development program, including its evaluation in earlier lines of therapy and combination regimens across multiple B-cell malignancies. Highlights include the first presentation of the primary results from the Phase 3 EPCORE DLBCL-4 study evaluating fixed duration epcoritamab plus lenalidomide in patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL). The results from EPCORE DLBCL-4 will also be highlighted in the ASH (Free ASH Whitepaper) 2026 Press Program.

Additional presentations include updated subgroup analyses from the Phase 3 EPCORE FL-1 study evaluating epcoritamab in combination with rituximab and lenalidomide in R/R follicular lymphoma (FL), follow-up from various monotherapy and combination trials, and real-world evidence and health economic analyses that further inform the evolving clinical profile of epcoritamab.

"The range of studies accepted for presentation at this year’s American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting reflects our commitment to exploring the full utility of epcoritamab and reinforces our confidence in epcoritamab’s potential to become a core therapy across B-cell malignancies, as a monotherapy and in combination with other medicines across lines of treatment," said Dr. Judith Klimovsky, Executive Vice President and Chief Development Officer of Genmab. "Together with our partner AbbVie, we look forward to sharing these findings with the global hematology community and further exploring what they could mean for patients."

2026 R&D Update and ASH (Free ASH Whitepaper) Data Review
On December 16 at 10:30 AM EST / 4:30 PM CET, Genmab will host its 2026 R&D Update and ASH (Free ASH Whitepaper) Data Review. The event will be virtual and webcast live. Details, including the webcast link and registration will be available on www.genmab.com. This meeting is not an official program of the ASH (Free ASH Whitepaper) Annual Meeting.

All regular abstracts accepted for presentation and publication have been published and may be accessed online on the ASH (Free ASH Whitepaper) Website. Late-breaking abstracts will be posted online on Monday, December 7, 2026, at 9:00 AM EST.

The following abstracts have been accepted for presentation at ASH (Free ASH Whitepaper):

Oral Presentations

Abstract Number Abstract Title Type of Presentation Date/Time of Presentation
79* ctDNA-directed intervention with epcoritamab alone or in combination with lenalidomide and rituximab is feasible in the early post-CAR-T population at high risk of relapse: Interim results from EpLCART Oral presentation December 12, 9:30-11:00 AM (Presentation: 9:30-9:45 AM)
105 Epcoritamab plus venetoclax leads to high response rates in relapsed or refractory chronic lymphocytic leukemia (R/R CLL): first results from Dose Cohorts 1 and 2 of the EPCORE CLL-1 trial Oral presentation December 12, 9:30-11:00 AM (Presentation: 10:00-10:15 AM)
166* A phase II trial of rituximab and epcoritamab as first-line therapy for patients with high tumor burden follicular lymphoma: Results from initial and expansion cohorts Oral presentation December 12, 12:00-1:30 PM (Presentation: 12:45-1:00 PM)
167* Phase II investigator-initiated trial of epcoritamab-lenalidomide in treatment naïve follicular lymphoma Oral presentation December 12, 12:00-1:30 PM (Presentation: 1:00-1:15 PM)
622 Durable benefit with fixed-duration epcoritamab + polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin, and prednisone (pola-R-CHP) as 1L treatment for patients with diffuse large B-cell lymphoma: 33-month follow-up from EPCORE NHL-5 Oral presentation December 13, 12:00-1:30 PM (Presentation: 12:45-1:00 PM)
919 Epcoritamab plus lenalidomide (E-Len) compared to rituximab plus gemcitabine and oxaliplatin (R-GemOx): Primary results from the phase 3 EPCORE DLBCL-4 study in relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) Oral presentation December 14, 2:45-4:15 PM (Presentation: 2:45- 3:00 PM)
*Investigator-led trial

Poster Presentations

Abstract Number Abstract Title Type of Presentation Date/Time of Presentation
1932 Efficacy and safety of epcoritamab + R-ICE in
relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL): Updated results from EPCORE NHL-2 Poster December 12, 5:30-7:30 PM
1933* Epcoritamab plus gemcitabine, dexamethasone, and cisplatin (Epco-GDP) demonstrates high complete response rates in relapsed/refractory large B-cell lymphoma eligible for autologous stem cell transplantation or CAR T-cell therapy: Results from a multicenter phase II investigator initiated trial Poster December 12, 5:30-7:30 PM
1957* A pilot study of epcoritamab with dose adjusted etoposide, cyclophosphamide, vincristine, doxorubicin, prednisone and rituximab (EPOCH-R) for treatment of newly diagnosed aggressive B-cell non-Hodgkin lymphomas: An investigator initiated trial in progress. Poster December 12, 5:30-7:30 PM
2109* Rapid tumor depletion and normalization of myeloid and lymphoid immune landscapes underlie the potent activity of the epcoritamab plus venetoclax combination in relapsed/refractory CLL after targeted therapies Poster December 12, 5:30-7:30 PM
2716 Real-world effectiveness of epcoritamab in third-line or later (3L+) settings in patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL): Insights from Real-EPCOR Poster December 12, 5:30-7:30 PM
3516 Epcoritamab retains robust cytotoxic activity in the setting of MS4A1 5-UTR splice variant V1 with markedly reduced CD20 protein levels Poster December 13, 6:00-8:00 PM
3517 Enhanced NK-cell and T-cell-dependent mechanisms underlie the benefit of epcoritamab combination with rituximab and lenalidomide in relapsed/refractory (R/R) B-cell non-Hodgkin lymphoma (NHL) Poster December 13, 6:00-8:00 PM
3519 Sustained minimal residual disease (MRD) negativity and favorable immune kinetics characterize long-term response to epcoritamab treatment in relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) Poster December 13, 6:00-8:00 PM
3550 Epcoritamab plus lenalidomide and rituximab (E+R2) shows a consistent safety profile and efficacy benefit over R2 in patients with relapsed or refractory follicular lymphoma (R/R FL): Updated subgroup analyses from the randomized phase 3 EPCORE FL-1 trial Poster December 13, 6:00-8:00 PM
3719* REPIFIR-AGR-GEL-23: A phase II study of epcoritamab in patients with relapsed or refractory large B-cell lymphoma in first relapse – a response-adapted approach guided by PET-CT and ctDNA-based MRD Poster December 13, 6:00-8:00 PM

4406 Cost-effectiveness of fixed-duration epcoritamab+rituximab and lenalidomide in patients with second-line or later relapsed/refractory follicular
lymphoma in the United States Poster December 13, 6:00-8:00 PM
5441* A phase II trial of epcoritamab prior to and after Anti-CD19 CAR T for relapsed or refractory large B cell lymphomas Poster December 14, 6:00-8:00 PM
5462* A prospective clinical trial of prophylactic siltuximab to prevent epcoritamab-associated cytokine release syndrome in relapsed/refractory B-cell lymphoma Poster December 14, 6:00-8:00 PM
5463 Health-related quality of life (HRQoL) in relapsed or
refractory diffuse large B-cell lymphoma (R/R DLBCL) with epcoritamab plus lenalidomide (E-Len) compared with rituximab plus gemcitabine and oxaliplatin (R-GemOx): Results of the EPCORE DLBCL-4 trial Poster December 14, 6:00-8:00 PM
*Investigator-led trial

e-Publications

Abstract Number Abstract Title Type of Presentation Date/Time of Presentation
NA Time and cost savings with fixed-duration epcoritamab + lenalidomide versus mosunetuzumab + polatuzumab for relapsed/refractory transplant- and CAR-T ineligible patients with diffuse large B-cell lymphoma Publication only NA
NA Epcoritamab for relapsed or refractory large B-cell
lymphoma in Japanese patients: interim analysis results from a real-world multicenter evaluation
(J-REALEPCO) Publication only NA
The safety and efficacy of epcoritamab have not been established for these investigational uses.

About Epcoritamab
Epcoritamab is an IgG1-bispecific antibody created using Genmab’s proprietary DuoBody technology and administered subcutaneously. Genmab’s DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to elicit an immune response toward target cell types. Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B cells and induces T-cell-mediated killing of CD20+ cells.i

Epcoritamab (approved under the brand name EPKINLY in the U.S. and Japan, and TEPKINLY in the EU) has received regulatory approval in certain lymphoma indications in more than 65 countries. Where approved, epcoritamab is a readily accessible therapy. Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies’ oncology collaboration. The companies share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization. Both companies will pursue additional international regulatory approvals for the relapsed or refractory (R/R) follicular lymphoma (FL) indication and additional approvals for the R/R diffuse large B-cell lymphoma (DLBCL) indication.

Genmab and AbbVie continue to evaluate the use of epcoritamab as a monotherapy, and in combination, across lines of therapy in a range of hematologic malignancies. This includes a trial evaluating epcoritamab in combination with lenalidomide and rituximab (R2) compared to chemoimmunotherapy in patients with previously untreated FL (NCT06191744). The safety and efficacy of epcoritamab has not been established for these investigational uses. Please visit www.clinicaltrials.gov for more information.

(Press release, Genmab, NOV 4, 2026, View Source [SID1234674215])

On November 4, 2026 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS" or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, reported that data from its completed Phase 2 study of SLS009 (tambiciclib) for the treatment of relapsed or refractory acute myeloid leukemia (r/r AML) will be presented at the 68th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, being held December 12–15, 2026 in New Orleans. This Phase 2 trial evaluated SLS009, a highly selective CDK9 inhibitor, in combination with azacitidine (AZA) and venetoclax (VEN) for the treatment of patients with r/r AML after prior VEN-based treatment.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"There is an urgent need in AML to address the growing number of patients who have either relapsed or become refractory to treatment with venetoclax," said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS Life Sciences. "Our participation at this year’s ASH (Free ASH Whitepaper) Annual Meeting reflects our continued focus on addressing this population by evaluating SLS009 in patients who have failed venetoclax therapy. We look forward to sharing these Phase 2 results with the hematology community and the continued advancement of our SLS009 program, which is currently being studied in newly diagnosed AML patients."

"Furthermore, we are excited and hopeful with our galinpepimut-S (GPS) clinical program, as we anticipate reporting the topline primary endpoint data in the Phase 3 REGAL study soon. Overall, we expect to have a strong presence at this year’s ASH (Free ASH Whitepaper) meeting as we continue our mission to develop medicines with the potential to advance the standard of care for patients with AML," added Dr. Stergiou.

Key outcomes of the SLS009 dose-ranging study in combination with azacitidine and venetoclax:

Population: 62 heavily pretreated patients whose AML relapsed or did not respond after venetoclax-based therapy. Median age was 70, and median number of prior lines was 2, with up to 8. High-risk mutations were common: ASXL1 41%, RUNX1 33%, TP53 29%.

Successfully Overcomes Venetoclax Resistance: SLS009 targets two primary drivers of venetoclax resistance: TP53 mutations and MCL-1 reliance. The combination demonstrates robust anti-leukemic activity in difficult-to-treat genetic and phenotypic populations following venetoclax failure.

Efficacy, All Doses (n=59): ORR 34% (12 CR/CRi, 8 MLFS) — 38% in AML-MR, 44% in monocytic AML and 36% in TP53-mutated AML.

Efficacy at the Selected Dose (30 mg twice weekly): Patients with monocytic AML achieved a 54% ORR with a median overall survival (mOS) of 5.8 months and patients with TP53-mutated AML achieved a 57% ORR and a mOS of 8.8 months, comparing favorably to historical outcomes in these adverse-risk settings of ~2.5 months.

Safety: Adding SLS009 to Aza/Ven was well tolerated with limited additive toxicities or treatment-related deaths. Non-hematologic treatment-related adverse events were predominantly mild (Grade 1/2) nausea and diarrhea.

"AML patients who progress after venetoclax-based therapy have very limited treatment options. Venetoclax resistance is largely driven by MCL-1 dependence," said Joshua Zeidner, MD, Principal Investigator and Professor of Medicine at University of North Carolina, Lineberger Comprehensive Cancer Center. "Furthermore, AML patients with TP53 mutations have poor outcomes with venetoclax-based therapy. The response rates of 57% in relapsed TP53-mutated and 54% in relapsed monocytic AML are encouraging and suggest that SLS009 acts on the biology that drives resistance. Continued investigation of SLS009 in combination with azacitidine and venetoclax in the frontline setting is now a natural development course for this therapy."

Enrollment and dosing continue in the ongoing 80-patient Phase 2 trial in newly diagnosed AML patients, including those who become refractory early to AZA/VEN treatment identified through extensive transcriptomics, genomics, and proteomics models. Early topline data are expected in Q4 2026. Additional information about the trial can be found at clinicaltrials.gov (NCT04588922).

"These results show that adding SLS009 can restore responses in this setting, including in TP53-mutated disease, without adding meaningful toxicity, which matters most for patients who have struggled to remain on venetoclax-based treatments due to poor tolerability," said Dragan Cicic, MD, Senior Vice President and Chief Development Officer of SELLAS Life Sciences. "We have now taken SLS009 into the frontline setting, guided by precision medicine. Our extensive biological and multi-omics analyses, including genomics and single-cell profiling, help us identify which patients could benefit most and when to add SLS009 to azacitidine and venetoclax. We expect first topline data from the Phase 2 frontline trial in Q4 2026, and we believe moving SLS009 into earlier lines of treatment will give it the best chance to change the course of this disease."

SLS009 (tambiciclib) Abstract Presentation Details:

Title: Tambiciclib (SLS009), a highly selective CDK9 inhibitor, in combination with azacitidine and venetoclax in relapsed/refractory AML after prior venetoclax: Results from a Phase 2 study
Session Date and Presentation Time: Monday, December 14, 2026, 6:00 – 8:00 PM CST
Session: 616. Acute Myeloid Leukemias: Investigational Drug and Cellular Therapies (Poster III)
Location: Ernest N. Morial Convention Center (MCCNO) – Hall F
Lead Author: Joshua F. Zeidner, MD, Professor of Medicine, Chief of Leukemia Research, The University of North Carolina School of Medicine
Abstract Number: 5155

(Press release, Sellas Life Sciences, NOV 4, 2026, View Source [SID1234674214])

On November 4, 2026 Lyell Immunopharma, Inc. (Nasdaq: LYEL), a late-stage clinical company advancing a pipeline of next-generation chimeric antigen receptor (CAR) T-cell therapies for patients with cancer, reported that it has entered into a securities purchase agreement for a private placement of approximately $80 million of its common stock. The investors include ARCH Venture Partners, Adage Capital Management LP, Caligan Partners LP, RTW Investments, a leading mutual fund and other new and existing institutional investors.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

The financing is expected to extend Lyell’s cash runway into 2028, providing capital to support key clinical and regulatory milestones for rondecabtagene autoleucel (ronde-cel), its next-generation dual-targeting CD19/CD20 CAR T-cell product candidate being developed for patients with relapsed/refractory (R/R) large B-cell lymphoma (LBCL). Lyell expects to present additional clinical data from the ongoing pivotal PiNACLE trial in the third-or later-line (3L+) LBCL setting at the 68th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition in December 2026, with the full pivotal dataset anticipated in mid-2027 and submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) expected to follow in the second half of 2027.

"This financing strengthens our financial position and supports the execution of our strategy as we approach several important clinical and regulatory milestones," said Smital Shah, Chief Financial and Business Officer of Lyell. "We see a significant clinical and commercial opportunity for ronde-cel, which has the potential to deliver durable responses with a one-time treatment that can be administered in the outpatient setting. We are pleased to have the strong support of our syndicate of high-quality existing and new investors as we advance toward these important milestones."

Ronde-cel is currently being evaluated in two pivotal trials: PiNACLE, a single-arm trial in the 3L+ LBCL setting intended to support an initial BLA submission for regular marketing approval, and PiNACLE-H2H, a Phase 3 randomized controlled trial comparing ronde-cel to investigator’s choice of an approved CD19-directed CAR T-cell therapy in the second-line (2L) setting. Ronde-cel has received Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations from the FDA for R/R diffuse LBCL in the 3L+ setting, as well as RMAT designation for LBCL in the 2L setting.

Lyell is also advancing LYL273, its GCC-targeted CAR T-cell product candidate for patients with metastatic colorectal cancer (mCRC). The program is progressing toward selection of a recommended Phase 2 dose and optimization of the safety management plan, with additional clinical data and a planned End-of-Phase 1 meeting with the FDA expected in 2027.

Private Placement Details

Under the terms of the securities purchase agreement, Lyell has agreed to sell 7,428,040 shares of common stock at a purchase price of $10.77 per share, equal to the closing price of Lyell’s common stock on November 3, 2026. The financing is expected to generate gross proceeds of approximately $80 million before deducting placement agent fees and other offering expenses. The private placement is expected to close on or about November 4, 2026, subject to customary closing conditions.

Goldman Sachs and Leerink Partners acted as placement agents in connection with the financing.

Lyell intends to use the net proceeds from the private placement, together with its existing cash, cash equivalents and marketable securities, to support the continued clinical development of ronde-cel, including its ongoing pivotal trials and planned regulatory submission activities, and the continued development of LYL273, as well as for working capital and other general corporate purposes.

Following the financing, Lyell expects its cash, cash equivalents and marketable securities to be sufficient to meet working capital and capital expenditure needs into 2028, including through the anticipated pivotal data and BLA submission for ronde-cel, as well as through the expected clinical data and regulatory update from the LYL273 development program in mCRC.

The offer and sale of the securities in the private placement are being made in a transaction not involving a public offering and have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or applicable state securities laws. Accordingly, the securities may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

The investors have been granted customary resale Form S-3 registration rights for the shares of common stock issued in the financing.

This press release shall not constitute an offer to sell, or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

(Press release, Lyell Immunopharma, NOV 4, 2026, View Source [SID1234674213])

On November 4, 2026 TuHURA Biosciences, Inc. (NASDAQ:HURA) ("TuHURA" or the "Company"), a Phase 3 immuno-oncology company developing novel therapeutics to overcome resistance to cancer immunotherapy, reported that it would present three posters on its research on the role of the Delta Opioid Receptor (DOR) in controlling the immunosuppressive capabilities of Myeloid-Derived Suppressor Cells (MDSCs) at the upcoming 68th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition taking place on December 12-15, 2026, in New Orleans, Louisiana.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"We continue to be impressed by uncovering the central role the DOR plays in proliferation, recruitment and immune suppressing capabilities across MDSCs, T regs and M2 macrophages, the 3 most important naturally occurring immune suppressing cells in the body. These immune suppressing cells are an important mechanism for the body to calm chronic inflammation, but when highjacked in the setting of cancer, they are known to be culprits in resistance to and failure of cancer immunotherapy," said Dr. James Bianco, President and Chief Executive Officer of TuHURA Biosciences. "In addition to providing information critical to multiple patent submissions, the data underscore the breadth of the potential therapeutic applications for DOR technology in the development of a first new class of non-tumor targeting, immune modulating ADCs."

Poster Presentation Details:

Abstract Number: 4725
Title: Inhibition of the delta opioid receptor (DOR) on myeloid-derived suppressor cells (MDSCs) significantly reduces Cxcl10, Saa3 and Acod1 gene expression, representing a single target to modulate MDSC proliferation, migration and immune suppression.
Presenter: Dr. Krit Ritthipichai, Director of Immunology
Session: 201. Granulocytes, Monocytes, and Macrophages: Poster III
Date and Time: Monday, December 14, 2026, 6:00pm to 8:00pm ET
Location: MCCNO – Hall F

Abstract Number: 4721
Title: Delta opioid receptor (DOR) inhibition drives both proenkephalin (PENK) gene expression and met-enkephalin (mENK) protein in tumor-derived myeloid-derived suppressor cells (tMDSC) and bone marrow-derived macrophage subtype 2 (BMDM2): Implications for modulation of immune suppression in cancer and autoimmune disease.
Presenter: Dr. Taekyoung Kwak, Lead Scientist, Immunology and Dr. Krit Ritthipichai, Director of Immunology
Session: 201. Granulocytes, Monocytes, and Macrophages: Poster III
Date and Time: Monday, December 14, 2026, 6:00pm to 8:00pm ET
Location: MCCNO – Hall F

Abstract Number: 4744
Title: Delta opioid receptor (DOR) inhibition drives both proenkephalin (PENK) gene expression and met-enkephalin (mENK) protein in tumor-derived myeloid-derived suppressor cells (tMDSC) and bone marrow-derived macrophage subtype 2 (BMDM2): Implications for modulation of immune suppression in cancer and autoimmune disease.
Presenter: Dr. Krit Ritthipichai, Director of Immunology
Session: 201. Granulocytes, Monocytes, and Macrophages: Poster III
Date and Time: Monday, December 14, 2026, 6:00pm to 8:00pm ET
Location: MCCNO – Hall F

(Press release, TuHURA Biosciences, NOV 4, 2026, View Source [SID1234674212])

On November 4, 2026 BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, reported that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review to the supplemental New Drug Application (sNDA) for BRUKINSA (zanubrutinib) in combination with rituximab for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL). The application is supported by data from the pivotal Phase 3 MANGROVE study, in which this chemotherapy-free regimen significantly reduced the risk of disease progression or death compared with standard chemoimmunotherapy. Full results from the MANGROVE study will be presented during the Plenary Scientific Session at the 68th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting on December 13, 2026.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Amit Agarwal, M.D., Ph.D., Chief Medical Officer, Hematology, BeOne Medicines, said:
"In newly diagnosed mantle cell lymphoma, chemoimmunotherapy remains a mainstay of frontline treatment despite the toxicity burden it carries. The FDA’s acceptance of our application brings us closer to a chemotherapy-free, BRUKINSA-based option that significantly reduces the risk of disease progression or death. BRUKINSA’s ability to drive deeper, more powerful responses is what makes a chemotherapy-free approach now possible. We look forward to working closely with the FDA to make our foundational BTK inhibitor available to patients as quickly as possible."

Filing based on potentially transformative MANGROVE results
The sNDA is supported by data from MANGROVE (BGB-3111-306), a global, randomized, Phase 3 trial evaluating BRUKINSA plus rituximab versus bendamustine plus rituximab (BR) in adult patients with previously untreated MCL. In the trial, BRUKINSA plus rituximab reduced the risk of progression or death by 43% versus BR (HR=0.57; 95% CI, 0.43–0.76; p<0.0001), meeting the trial’s primary endpoint of progression-free survival (PFS) as assessed by an independent review committee. The safety profile of BRUKINSA plus rituximab was consistent with the known safety profiles of both medicines, and no new safety signals were identified.

A supplemental new drug application for BRUKINSA for the treatment of MCL has also been submitted to the European Medicines Agency (EMA) and accepted by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA).

BRUKINSA is currently approved in the U.S. for adult patients with relapsed or refractory (R/R) MCL, as well as for chronic lymphocytic leukemia/small lymphocytic lymphoma, Waldenström’s macroglobulinemia, R/R marginal zone lymphoma, and R/R follicular lymphoma.

About MANGROVE
MANGROVE is a global, randomized, open-label Phase 3 trial evaluating BRUKINSA plus rituximab versus bendamustine plus rituximab in adult patients with previously untreated mantle cell lymphoma. The trial enrolled 510 patients across 157 active sites worldwide and is the first Phase 3 trial to evaluate a chemotherapy-free, BTK inhibitor-based regimen against standard chemoimmunotherapy with BR in the frontline MCL setting.

In the experimental arm, patients received BRUKINSA at 160 mg orally twice daily plus rituximab during the initial treatment period, followed by BRUKINSA monotherapy until disease progression or intolerance. In the control arm, patients received bendamustine plus rituximab for six cycles. The primary endpoint is PFS assessed by IRC. Overall survival is a key secondary endpoint for the study. Other secondary endpoints include investigator-assessed PFS, overall response rate (ORR), duration of response (DOR), patient-reported outcomes, and safety.

About BRUKINSA (zanubrutinib)
BRUKINSA is a next-generation Bruton tyrosine kinase (BTK) inhibitor designed to deliver complete and sustained BTK inhibition, enabled by optimized pharmacokinetics, including bioavailability, half-life, and selectivity, resulting in consistent target coverage in disease-relevant tissues.

BRUKINSA is the foundational BTK inhibitor and the first and only to demonstrate progression-free survival superiority over another BTK inhibitor in a Phase 3 study, setting a new benchmark for efficacy in the class. With the broadest label globally, it is also the only BTK inhibitor that offers the convenience of once- or twice-daily dosing to support individualized treatment.

The global BRUKINSA clinical development program spans more than 8,000 patients across over 45 trials in 30+ countries and regions. Approved in more than 80 markets, BRUKINSA has been used to treat over 310,000 patients worldwide, reflecting its rapidly expanding role as a standard of care across B-cell malignancies.

Select Important Safety Information for BRUKINSA
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.

(Press release, BeOne Medicines, NOV 4, 2026, View Source [SID1234674211])