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.

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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])

On November 4, 2026 Autolus Therapeutics plc (Nasdaq: AUTL), a commercial-stage biopharmaceutical company developing, manufacturing and delivering next-generation programmed T cell therapies and candidates, reported the online publication of abstracts submitted to the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, to be held December 12-15, 2026, in New Orleans, Louisiana.

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Abstract 4498 – Oral Presentation
Title: What to expect during the first 3 months post obecabtagene autoleucel (obe-cel) infusion in adult relapsed/refractory (R/R) B-cell acute lymphoblastic leukemia (B-ALL): A deepening of measurable residual disease (MRD) response and recovery from cytopenias
Session name: Acute Lymphoblastic Leukemias: Therapies Excluding Allogeneic Transplantation: Relapsed/Refractory Acute Lymphoblastic Leukemia: From Novel CAR T-cell Constructs to Real-World Experience in B-ALL, and an Investigational Agent in T-cell ALL
Presentation date and time: December 12, 2026; 5:00 – 5:15 PM ET
Presentation room: MCCNO – 265-268
Publication number: 377
Presenting author: Elias Jabbour, MD; D.B. Lane Cancer Research Fund Distinguished Professor in Leukemia Research; Section Chief Acute Lymphoblastic Leukemia; MD Anderson Cancer Center, Houston, Texas

Summary: In an evaluation of efficacy, safety and hematologic recovery during the first three months after infusion to define early clinical expectations following obe-cel treatment, MRD responses continued to deepen beyond month one, with patients who achieved delayed MRD negativity experiencing outcomes comparable to early responders. These findings may help define early clinical expectations following obe-cel treatment and inform patient management strategies.

Abstract 273 – Poster Presentation
Title: Analytical and clinical concordance of droplet digital PCR (ddPCR) and quantitative PCR (qPCR) assays to monitor obecabtagene-autoleucel (obe-cel) presence in adults with relapsed/refractory B-cell acute lymphoblastic leukemia (R/R B-ALL)
Session Name: 614. Acute Lymphoblastic Leukemias: Biomarkers, Molecular Markers, and Measurable Residual Disease in Diagnosis and Prognosis: Poster III
Presentation date and time: December 14, 2026; 6:00 PM – 8:00 PM ET
Presentation room: MCCNO – Hall F
Publication number: 5094
Presenting author: Aaron Logan, MD; Professor of Medicine; Director, Cellular Therapy Program; Division of Hematology, Blood and Marrow Transplant, and Cellular Therapy; University of California, San Francisco (UCSF), San Francisco, California

Summary: Recently, a novel qPCR assay was developed, validated, and made available in a reference laboratory to enable monitoring of obe-cel levels. Concordance between the ddPCR and qPCR assay results within this subset of patients from FELIX is sufficient and acceptable to support the use of the commercially available qPCR assay for patients in clinical practice.

Abstract 11291 – Poster Presentation
Title: Initial results of the phase 1 UKMRA ALARIC trial assessing BCMA and BCMA/CD19 CAR-T for the treatment of relapsed/refractory AL amyloidosis
Session name: 652. MGUS, Amyloidosis, and Other Non-Myeloma Plasma Cell Dyscrasias: Clinical and Epidemiological: Poster I
Presentation date and time: December 12, 2026, 5:30-7:30 PM
Presentation room: MCCNO – Hall F
Publication number: 2185
Presenting author: Lydia Lee, Associate Professor, UCL Cancer Institute; Consultant Haematologist, UCLH

Summary: ALARIC is a phase 1 trial evaluating Fab-based BCMA (D8) CAR-T cells, alone or co-transduced with a CD19 CAR (AUTO8), in relapsed/refractory systemic AL amyloidosis. All of the first four patients treated with D8 alone achieved rapid complete haematological response, with good tolerability and encouraging improvements in organ function at a median five-month follow-up.

(Press release, Autolus, NOV 4, 2026, View Source [SID1234674210])

On November 4, 2026 Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY), a clinical-stage biopharmaceutical company and a global leader in epigenetics, reported updated positive clinical data from early-stage clinical trials of its selective LSD1 inhibitor iadademstat in acute myeloid leukemia and inmyeloproliferative neoplasms. The findings will be presented in poster sessions at the American Society of Hematology (ASH) (Free ASH Whitepaper) 68th Annual Meeting, taking place December 12-15, 2026 in New Orleans, Louisiana.

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"We look forward to returning to ASH (Free ASH Whitepaper) and sharing exciting new clinical data on iadademstat with the hematologic oncology community," said Carlos Buesa, Chief Executive Officer of Oryzon. "We now have a growing amount of clinical evidence supporting the very promising efficacy of iadademstat in combination with standard-of-care treatment in AML, including in populations that respond poorly to current treatments, together with a manageable safety profile. In particular, the ALICE-2 data strongly support the tolerability of the combination, provide a clear rationale for dose selection for further development, and show highly encouraging efficacy. Together, these findings form a robust evidence package to support advancement into the planned ALICE-3 Phase III trial in newly diagnosed AML."

"The AML findings and early data in myeloproliferative neoplasms (MPN) represent complementary steps in understanding iadademstat’s therapeutic potential," said Ana Limon, Oryzon’s Senior Vicepresident for Clinical Development in Oncology. "ALICE-2 is helping guide our next stage of development in AML, while the preliminary MPN findings open a new avenue for investigation. Although these MPN data are early, they provide a foundation for further clinical evaluation."

Presentations details:

Title: A Phase Ib study of the triplet combination of iadademstat in combination with azacitidine and venetoclax for newly-diagnosed acute myeloid leukemia
Publication ID: 1634
Session Name: 616. Acute Myeloid Leukemias: Investigational Drug and Cellular Therapies: Poster I
Presentation date and time: December 12, 2026, 5:30-7:30 pm local time
Room: MCCNO – Hall F

As of the July 2026 data cut of the ALICE-2 study (NCT06357182), the iadademstat/azacitidine/venetoclax triplet combination continued to demonstrate a manageable safety profile with encouraging efficacy in newly diagnosed acute myeloid leukemia (ND-AML), with high remission rates, rapid responses, acceptable hematologic recovery, and encouraging early survival. Among 19 efficacy-evaluable patients, ORR was 95%, including 84% composite complete remission (CRc) rate and 74% pure complete remission (CR) rate. After median follow-up of 8 months, 12-month overall survival (OS) was 76%, with median OS not yet reached. In patients with ELN2022 intermediate- or adverse-risk disease, 12-month OS rates were 100% and 74%, respectively, with median OS not reached. 82% of enrolled patients had ELN2022 adverse risk. Updated data with additional patients and more mature responses will be presented at the meeting.

Title: Iadademstat combination with gilteritinib is a safe and effective treatment in FLT3‑mutated relapsed/refractory acute myeloid leukemia: Topline results of the FRIDA trial
Publication ID: 1628
Session Name: 616. Acute Myeloid Leukemias: Investigational Drug and Cellular Therapies: Poster I
Presentation date and time: December 12, 2026, 5:30-7:30 pm local time
Room: MCCNO – Hall F

The iadademstat/gilteritinib combination evaluated in the FRIDA Phase Ib trial (NCT05546580) demonstrated a manageable safety profile, similar to SoC treatment. In a high-risk, heavily pre-treated and refractory FLT3-mutant AML population, the combination achieved a high 67% composite complete remission rate and a 31% 12-month survival rate at the recommended Phase 2 dose (RP2D). Additional data will be presented at the meeting.

Title: Interim results of a phase II study of ASTX727 with or without iadademstat in patients with accelerated/blast-phase myeloproliferative neoplasms
Publication ID: 5532
Session Name: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Poster III
Presentation date and time: December 14, 2026, 6:00-8:00 pm local time
Room: MCCNO – Hall F

Interim results from the study (NCT06661915), based on data available as of the ASH (Free ASH Whitepaper) 2026 abstract submission cut-off date, showed that the combination of iadademstat and ASTX727 was well tolerated, with no dose-limiting toxicities (DLTs) observed. 50% of patients treated with the combination achieved acute leukemia response-partial (ALR-P) as best response. The trial continues in the dose escalation phase, 3 and higher iadademstat dose level cohorts will be explored to inform the selection of a recommended Phase 2 dose of iadademstat for the randomized portion of the study.

The abstracts are available online at the ASH (Free ASH Whitepaper) 2026 website.

(Press release, Oryzon, NOV 4, 2026, View Source;utm_medium=email&utm_campaign=NdP.27+2026-11-04+ASH+abstracts+ENG856 [SID1234674209])

On November 4, 2026 Gilead Sciences, Inc. (Nasdaq: GILD) and Kite, a Gilead Company, reported 23 presentations, including 7 oral presentations, will be presented at the 68th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition (December 12–15, 2026).

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These latest clinical milestones demonstrate transformative progress across Gilead and Kite’s pipeline and portfolio, from new data for the investigational anitocabtagene autoleucel (anito-cel) in relapsed or refractory (RR) multiple myeloma (MM), to early clinical results from our next-generation approaches in lymphoma and autoimmune blood disorders, and long-term follow-up data supporting standard-of-care therapies.

"People living with blood cancers deserve treatments that offer more than a response; they deserve the possibility of lasting freedom from disease," said Gallia Levy, MD, PhD, Senior Vice President, Global Head of Development at Kite. "The data we are presenting reflect the breadth of our leadership and our commitment to advancing next-generation cell therapy, so more patients can benefit across multiple cancers and throughout their treatment journey."

Key presentations at ASH (Free ASH Whitepaper) 2026

Deepening and Expanding Clinical Evidence for Anito-cel in MM: Anito-cel is an investigational CAR T-cell therapy for the treatment of RRMM. At ASH (Free ASH Whitepaper), Kite will present 18-month minimum follow-up results from the pivotal Phase 2 iMMagine-1 open-label, single-arm, multicenter study of anito-cel in people who received three or more prior lines of therapy, including treatments from all three major drug classes for MM, alongside new comparative and collaborative research in the disease.

iMMagine-1 (4L+ RRMM): Maturing efficacy data, including progression-free survival (PFS) and overall survival (OS) analyses, alongside updated safety outcomes, from the pivotal Phase 2 open-label, single-arm study of anito-cel in RRMM. Data from the iMMagine-1 trial are the basis of the U.S. Food and Drug Administration (FDA) Biologics License Application (BLA) submission, which is under review with a Prescription Drug User Fee Act (PDUFA) target date of December 23, 2026.
Comparative Analyses (RRMM): New matching-adjusted indirect comparison (MAIC) analyses examining the efficacy and safety of anito-cel versus bispecific antibodies and other CAR T-cell therapies.
GEM-AnitoFIRST (Newly Diagnosed MM): Data from the open-label, non-randomized Phase 2 study being conducted in collaboration with the PETHEMA Foundation (Programa Español de Tratamiento en Hematología) evaluating anito-cel in newly diagnosed MM.
Expanding Real-World Use and Long-Term Evidence Underscore the Track Record for Yescarta:

ZUMA-12 (1L High-Risk LBCL): Five-year follow-up from the first prospective Phase 2, single-arm, open-label study evaluating Yescarta (axicabtagene ciloleucel) as a first-line treatment for high-risk large B-cell lymphoma (LBCL) patients who remain positron emission tomography (PET)-positive after two cycles of chemoimmunotherapy.
Real-World Evidence: Expanding real-world data, including outcomes from the French collaborative group The Lymphoma Study Association/Lymphoma Academic Research Organization (LYSA/LYSARC) (DESCAR-T) registry across established and newly authorized treatment centers, and Canadian data assessing the feasibility and safety of outpatient CAR T administration.
GELTAMO LATE-R: Second interim analysis of the Phase 2, single-arm, open-label study of axicabtagene ciloleucel in patients with late-relapsing LBCL after completing first-line chemoimmunotherapy (CIT).
Initial Global Clinical Experience with Investigational Gamgertamig (CM336/OM336) in Relapsed/Refractory Autoimmune Cytopenias (AICs): Gilead and Lakefront Biotherapeutics (Lakefront) are collaborating to advance programs in inflammation, including the development of gamgertamig (CM336/OM336), an investigational BCMAxCD3 bispecific T cell engager for the treatment of autoantibody-driven, immune-mediated disease. New data from two ongoing Phase 1b studies will provide initial clinical experience with short-course subcutaneous gamgertamig, administered over a maximum of three weeks in people with relapsed or refractory AICs.

Immune Thrombocytopenia (ITP): Response, time-to-response and durability data across three dose cohorts in people with relapsed or refractory ITP, a rare autoantibody-driven disease that causes platelet destruction and increased bleeding risk.
Autoimmune Hemolytic Anemia (AIHA): Response, time-to-response and durability data across three dose cohorts in people with relapsed or refractory AIHA, a rare autoantibody-driven disease that causes destruction of red blood cells leading to anemia.
Dates and times are listed in CT for the following accepted abstracts and presentations:

Abstract Details

Titles

Oral Presentations

Anitocabtagene Autoleucel

Abstract #273

Saturday, December 12

2:30 – 2:45 PM

MCCNO – La Nouvelle C

Updated Analysis of iMMagine-1, a Phase 2 Registrational Study of Anitocabtagene Autoleucel (Anito-cel) for the Treatment of Patients (Pts) with Relapsed and/or Refractory Multiple Myeloma (RRMM)

Abstract #6579

Saturday, December 12

9:30 – 9:45 AM

MCCNO – Hall E

Anitocabtagene Autoleucel Following Induction Therapy in Newly Diagnosed Multiple Myeloma: Early Safety, Response, and MRD Results from the Phase 2 GEM-AnitoFIRST Study*

Collaboration with PETHEMA Foundation

Axicabtagene Ciloleucel

Abstract #1031

Monday, December 14

5:30 – 5:45 PM

MCCNO – New Orleans Theatre A

Axicabtagene Ciloleucel as Second-line Treatment for Late-relapsed Aggressive Large B-cell Lymphoma: Second Interim Analysis of the GELTAMO LATE-R Phase II Trial*

Collaboration with GELTAMO

Abstract #614

Saturday, December 12

12:15 – 12:30 PM

MCCNO – New Orleans Theatre C

Real-world Outcomes After Axicabtagene Ciloleucel as 2nd- vs 3rd-line Therapy in Large B-cell Lymphoma: A Propensity Score-matched Analysis from the French DESCAR-T Registry*

Collaboration with LYSA/LYSARC

Abstract #613

Sunday, December 13

12:00 – 12:15 PM

MCCNO – New Orleans Theatre C

A Prospective Clinical Trial of Comprehensive Ablative Bridging Irradiation (CABI) Prior to Axicabtagene Ciloleucel for Relapsed or Refractory Large B Cell Lymphoma

Abstract #703

Sunday, December 13

4:30 – 4:45 PM

MCCNO – New Orleans Theatre B

Double-dose Axicabtagene Ciloleucel (Axi-Cel-2) as Second-line Therapy for High-risk Relapsed or Refractory Large B-cell Lymphoma: Results from the Phase 1b ENCORE-1 Trial

Additional CAR T-Cell Therapy

Abstract #1056

Monday, December 14

5:45 – 6:00 PM

MCCNO – 388-390

Armored TmCD19-IL18 CAR T cells in patients with CD19+ lymphomas

Poster Presentations

Anitocabtagene Autoleucel

Abstract #4042

Sunday, December 13

6:00 – 8:00 PM

MCCNO – Hall F

Matching-Adjusted Indirect Comparisons (MAICs) of Anitocabtagene Autoleucel (anito-cel) vs Teclistamab and Talquetamab for the Treatment of 4L+ Relapsed and/or Refractory Multiple Myeloma (RRMM): Analysis with Extended iMMagine-1 Follow-up

Abstract #4043

Sunday, December 13

6:00 – 8:00 PM

MCCNO – Hall F

Matching-Adjusted Indirect Comparisons (MAICs) of Efficacy and Safety Outcomes for Anitocabtagene Autoleucel Versus Ciltacabtagene Autoleucel in 4L+ Relapsed and/or Refractory Multiple Myeloma (RRMM): Analysis with Extended iMMagine-1 Follow-up

KITE-753

Abstract #5944

Monday, December 14

6:00 – 8:00 PM

MCCNO – Hall F

Response Durability and Early Immune Cell Recovery: Updated Results from the Phase 1 Multicenter PALISADES-1 Study of KITE-753 in Relapsed/Refractory B-cell Lymphoma

Axicabtagene Ciloleucel

Abstract #1912

Saturday, December 12

5:30 – 7:30 PM

MCCNO – Hall F

5-year Follow-up of the Phase 2 ZUMA-12 Study of Axicabtagene Ciloleucel (Axi-cel) as First-line Therapy in Patients (Pts) with High-risk Large B-cell Lymphoma (LBCL)

Abstract #2632

Saturday, December 12

5:30 – 7:30 PM

MCCNO – Hall F

Feasibility of Outpatient Axicabtagene Ciloleucel (Axi-cel) for Relapsed/Refractory Large B-Cell Lymphoma: A Single-Centre Analysis in Canada

Abstract #2728

Saturday, December 12

5:30 – 7:30 PM

MCCNO – Hall F

Audit of the Uptake of Second Line Axicabtagene Ciloleucel for Relapsed/Refractory Large B-cell Lymphoma in the Welsh Population with Assessment of the Impact of Deprivation on Access to and Response Following First Line Chemoimmunotherapy

Impact of Fludarabine Exposure Levels During Lymphodepletion on the Efficacy and Toxicity of Axicabtagene Ciloleucel in Large B-cell Lymphoma: A Multicenter Retrospective Study

Brexucabtagene Autoleucel

Abstract #5081

Monday, December 14

6:00 – 8:00 PM

MCCNO – Hall F

Brexucabtagene Autoleucel as Consolidation Therapy in Adult Patients with High-risk Philadelphia (Ph)-negative B-cell Acute Lymphoblastic Leukemia

Real-world outcomes after second CD19-directed CAR T cell treatment for relapsed/refractory B cell acute lymphoblastic leukemia

CD19-directed CAR T-cell therapy with brexucabtagene autoleucel or obecabtagene autoleucel produces durable remission for CML patients in lymphoid blast phase: A Rocca consortium multicenter analysis

High Efficacy of Obe-cel and Brexu-cel in Patients with Extramedullary B-ALL

Additional CAR T-Cell Therapy

Abstract #4107

Sunday, December 13

6:00 – 8:00 PM

MCCNO – Hall F

Depth of Lymphodepletion, Measured by IL-15 Serum Levels, as a Modifiable Risk Factor for Neurotoxicity and Non-relapse Mortality: Results from Large-scale Protein Screening Across 710 Patients Treated with Anti-CD19 CAR T Cell Therapy

Access to CAR T cell therapy for adults with multiple myeloma or large B-cell lymphoma: Patient, caregiver, and clinician perspectives

Gamgertamig

Abstract #3008

Sunday, December 13

6:00 – 8:00 PM

MCCNO – Hall F

Initial global clinical experience with gamgertamig (CM336/OM336), a BCMAxCD3 T‑cell engager, in relapsed/refractory autoimmune cytopenias (AICs) in two parallel ongoing studies (NCT07083960, NCT07175493)*

Collaboration with Lakefront

Publication Only

Abstract #7562

Real-world (RW) Outcomes of Patients (Pts) with Relapsed or Refractory (R/R) Large B-cell Lymphoma (LBCL) Treated with Axicabtagene Ciloleucel (Axi-cel) in Non-Joint Accreditation Committee ISCT-Europe & EBMT (JACIE) Accredited Centers in France from the DESCAR-T Registry

*Kite collaborative or investigator-initiated studies

For remaining presentation information, please visit: View Source

About Yescarta & Tecartus

YESCARTA (axicabtagene ciloleucel) and TECARTUS (brexucabtagene autoleucel) are genetically modified autologous T-cell immunotherapies that use a patient’s own T cells, which are modified ex vivo to express a chimeric antigen receptor (CAR) designed to recognize CD19. The anti-CD19 CAR T cells are expanded and infused back into the patient, where they recognize and kill CD19-expressing target cells.

U.S. Indications for YESCARTA and TECARTUS

YESCARTA is indicated for the treatment of adult patients with large B-cell lymphoma (LBCL) that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy; adult patients with relapsed or refractory (R/R) LBCL after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma; and adult patients with R/R follicular lymphoma (FL) after two or more lines of systemic therapy. The FL indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefits in a confirmatory trial.

TECARTUS is indicated for the treatment of adult patients with R/R mantle cell lymphoma (MCL) and adult patients with R/R B-cell precursor acute lymphoblastic leukemia (ALL).

U.S. Important Safety Information for YESCARTA and TECARTUS

BOXED WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES and SECONDARY HEMATOLOGICAL MALIGNANCIES

Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving YESCARTA or TECARTUS. Do not administer YESCARTA or TECARTUS to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids.
Neurologic toxicities, including fatal or life-threatening reactions, occurred in patients receiving YESCARTA or TECARTUS, including concurrently with CRS or after CRS resolution. Monitor for neurologic toxicities after treatment with YESCARTA or TECARTUS. Provide supportive care and/or corticosteroids as needed.
T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including YESCARTA.
YESCARTA Warnings and precautions

Serious hypersensitivity reactions may occur during YESCARTA infusion. Monitor patients for hypersensitivity reactions during infusion.
Severe or life-threatening infections occurred in patients after YESCARTA infusion. Infections (all grades) occurred in 45% of patients with NHL. Grade 3 or higher infections occurred in 17% of patients, including Grade 3 or higher infections with an unspecified pathogen in 12%, bacterial infections in 5%, viral infections in 3%, and fungal infections in 1%. YESCARTA should not be administered to patients with clinically significant active systemic infections. Monitor patients for signs and symptoms of infection before and after YESCARTA infusion and treat appropriately. Administer prophylactic antimicrobials according to local guidelines. Febrile neutropenia was observed in 36% of patients with NHL after YESCARTA infusion and may be concurrent with CRS. In the event of febrile neutropenia, evaluate for infection and manage with broad-spectrum antibiotics, fluids, and other supportive care as medically indicated. In immunosuppressed patients, including those who have received YESCARTA, life-threatening and fatal opportunistic infections including disseminated fungal infections have been reported. The possibility of HHV-6 encephalitis and PML should be considered in immunosuppressed patients with neurologic events and appropriate diagnostic evaluations should be performed. Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, has occurred in patients treated with drugs directed against B cells, including YESCARTA. Perform screening for HBV, hepatitis C virus (HCV), and human immunodeficiency virus (HIV) in accordance with clinical guidelines before collection of cells for manufacturing.
Prolonged Cytopenias: Patients may exhibit cytopenias for several weeks following lymphodepleting chemotherapy and YESCARTA infusion. Grade 3 or higher cytopenias not resolved by Day 30 following YESCARTA infusion occurred in 39% of all patients with NHL and included neutropenia (33%), thrombocytopenia (13%), and anemia (8%). Monitor blood counts after YESCARTA infusion.
Hypogammaglobulinemia: B-cell aplasia and hypogammaglobulinemia can occur in patients receiving treatment with YESCARTA. Hypogammaglobulinemia was reported as an adverse reaction in 14% of all patients with NHL. Monitor immunoglobulin levels after treatment with YESCARTA and manage using infection precautions, antibiotic prophylaxis, and immunoglobulin replacement.
Secondary Malignancies: Patients treated with YESCARTA may develop secondary malignancies. T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including YESCARTA. Monitor life-long for secondary malignancies. In the event that a secondary malignancy occurs, contact Kite at 1-844-454-KITE (5483).
YESCARTA Adverse reactions

The most common adverse reactions (incidence ≥ 30%), excluding laboratory abnormalities, in patients with non-Hodgkin lymphoma are CRS, fever, hypotension, encephalopathy, fatigue, tachycardia, headache, nausea, febrile neutropenia, diarrhea, musculoskeletal pain, infections with pathogen unspecified, chills and decreased appetite. The most common Grade 3-4 laboratory abnormalities (≥ 30%) are leukopenia, lymphopenia, neutropenia, anemia, thrombocytopenia, and hypophosphatemia.
YESCARTA Dosage and administration

For autologous use only. For intravenous use only.

Dosing of YESCARTA is based on the number of chimeric antigen receptor (CAR)-positive viable T cells. The target YESCARTA dose is 2 × 10 6 CAR-positive viable T cells per kg body weight, with a maximum of 2 × 10 8 CAR-positive viable T cells.
Pretreatment: Administer a lymphodepleting chemotherapy regimen of cyclophosphamide 500 mg/m 2 intravenously and fludarabine 30 mg/m 2 intravenously on the fifth, fourth, and third day before infusion of YESCARTA.
Premedication: Premedicate with acetaminophen and an H1-antihistamine.
Confirm availability of tocilizumab andverify the patient’s identity prior to infusion.
Do NOT use a leukodepleting filter.
Infuse the entire contents of the YESCARTA bag within 30 minutes of thawing by either gravity or a peristaltic pump. YESCARTA is stable at room temperature for up to 3 hours after thaw.
TECARTUS Warnings and precautions

Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome (HLH/MAS), including life-threatening reactions, occurred following treatment with TECARTUS. HLH/MAS occurred in 4% (3/78) of patients with ALL. Two patients experienced Grade 3 events, and 1 patient experienced a Grade 4 event. All 3 patients with HLH/MAS had concurrent CRS symptoms and neurologic events after TECARTUS infusion. Treatment of HLH/MAS should be administered per institutional standards.
Serious hypersensitivity reactions, including anaphylaxis, may occur due to dimethyl sulfoxide or residual gentamicin in TECARTUS.
Severe or life-threatening infections occurred in patients after TECARTUS infusion. Infections (all grades) occurred in 63% (105/168) of patients with MCL and 44% (34/78) of patients with ALL. Grade 3 or higher infections, including bacterial, viral, and fungal infections, occurred in 33% of patients with MCL and 29% of patients with ALL. TECARTUS should not be administered to patients with clinically significant active systemic infections. Monitor patients for signs and symptoms of infection before and after TECARTUS infusion and treat appropriately. Administer prophylactic antimicrobials according to local guidelines. Febrile neutropenia was observed in 4% of patients with MCL and 35% of patients with ALL after TECARTUS infusion and may be concurrent with CRS. The febrile neutropenia in 27 (35%) patients with ALL includes events of "febrile neutropenia" (11 (14%)) plus the concurrent events of "fever" and "neutropenia" (16 (21%)). In the event of febrile neutropenia, evaluate for infection and manage with broad spectrum antibiotics, fluids, and other supportive care as medically indicated. In immunosuppressed patients, life-threatening and fatal opportunistic infections have been reported. The possibility of rare infectious etiologies should be considered in patients with neurologic events and appropriate diagnostic evaluations should be performed. Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients treated with drugs directed against B cells. Perform screening for HBV, hepatitis C virus (HCV), and human immunodeficiency virus (HIV) in accordance with clinical guidelines before collection of cells for manufacturing.
Prolonged Cytopenias: Patients may exhibit cytopenias for several weeks following lymphodepleting chemotherapy and TECARTUS infusion. In patients with MCL, Grade 3 or higher cytopenias not resolved by Day 30 following TECARTUS infusion occurred in 55% (92/168) of patients and included thrombocytopenia (32%), neutropenia (42%), and anemia (14%). In patients with ALL who were responders to TECARTUS treatment, Grade 3 or higher cytopenias not resolved by Day 30 following TECARTUS infusion occurred in 20% (7/35) of the patients and included neutropenia (12%) and thrombocytopenia (12%); Grade 3 or higher cytopenias not resolved by Day 60 following TECARTUS infusion occurred in 11% (4/35) of the patients and included neutropenia (9%) and thrombocytopenia (6%). Monitor blood counts after TECARTUS infusion.
Hypogammaglobulinemia: B cell aplasia and hypogammaglobulinemia can occur in patients receiving treatment with TECARTUS. Hypogammaglobulinemia was reported in 14% (23/168) of patients with MCL and 9% (7/78) of patients with ALL. Monitor immunoglobulin levels after treatment with TECARTUS and manage using infection precautions, antibiotic prophylaxis, and immunoglobulin replacement.
Secondary Malignancies: Patients treated with TECARTUS may develop secondary malignancies. T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies. Monitor life-long for secondary malignancies. In the event that a secondary malignancy occurs, contact Kite at 1-844-454-KITE (5483).
TECARTUS Adverse reactions

The most common non-laboratory adverse reactions (incidence ≥ 20%) are:
MCL: CRS, fever, encephalopathy, hypotension, infection with pathogen unspecified, viral infections, fatigue, tachycardias, chills, hypoxia, tremor, cough, musculoskeletal pain, nausea, edema, headache, constipation, diarrhea, decreased appetite, dyspnea, rash, insomnia, pleural effusion, aphasia, motor dysfunction.
ALL: fever, CRS, hypotension, encephalopathy, tachycardia, nausea, chills, headache, fatigue, febrile neutropenia, diarrhea, musculoskeletal pain, hypoxia, rash, edema, tremor, infection with pathogen unspecified, constipation, decreased appetite, and vomiting.
TECARTUS Dosage and administration

For autologous use only. For intravenous use only.

Dosing of TECARTUS is based on the number of chimeric antigen receptor (CAR)-positive viable T cells.
MCL: The target TECARTUS dose is 2 × 10 6 CAR-positive viable T cells per kg body weight, with a maximum of 2 × 10 8 CAR-positive viable T cells.
Pretreatment: Administer a lymphodepleting chemotherapy regimen of cyclophosphamide 500 mg/m 2 intravenously and fludarabine 30 mg/m 2 intravenously on the fifth, fourth, and third day before infusion of TECARTUS.
ALL: The target TECARTUS dose is 1 × 10 6 CAR-positive viable T cells per kg body weight, with a maximum of 1 × 10 8 CAR-positive viable T cells.
Pretreatment: Administer a lymphodepleting chemotherapy regimen of fludarabine 25 mg/m 2 intravenously over 30 minutes on the fourth, third, and second day and administer cyclophosphamide 900 mg/m 2 over 60 minutes on the second day before infusion of TECARTUS.
Premedication: Premedicate with acetaminophen and an H1-antihistamine.
Confirm availability of tocilizumab andverify the patient’s identity prior to infusion.
Do NOT use a leukodepleting filter.
Infuse the entire contents of the TECARTUS bag within 30 minutes of thawing by either gravity or a peristaltic pump. TECARTUS is stable at room temperature for up to 3 hours after thaw.
U.S. Full Prescribing Information for YESCARTA and TECARTUS, including BOXED WARNINGS, are available at www.kitepharma.com.

(Press release, Gilead Sciences, NOV 4, 2026, View Source [SID1234674208])

On November 4, 2026 Kura Oncology, Inc. (Nasdaq: KURA) and Kyowa Kirin Co., Ltd (TSE: 4151) reported that eight abstracts related to ziftomenib, including four oral presentations and four posters, have been accepted for presentation at the 2026 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, taking place December 12-15 in New Orleans. Kura and Kyowa Kirin are working together under a strategic collaboration and license agreement to develop and commercialize ziftomenib for the treatment of acute myeloid leukemia (AML) worldwide.

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The presentations will include the first clinical results for ziftomenib in combination with the FLT3 inhibitors quizartinib and gilteritinib, longer-term frontline data for ziftomenib plus venetoclax and azacitidine, and an exploratory analysis of ziftomenib activity in molecularly defined AML subtypes beyond NPM1-mutated and KMT2A-rearranged disease.

"Our strategy is to establish ziftomenib as a preferred menin inhibitor for combination treatment, supported by clinical evidence across complementary therapeutic approaches," said Mollie Leoni, M.D., Chief Medical Officer of Kura Oncology. "Our first clinical results with quizartinib and gilteritinib extend this strategy into FLT3 inhibitor combinations. Together with longer-term venetoclax and azacitidine results and studies of additional combinations, these presentations will help define ziftomenib’s potential as a backbone therapy from initial diagnosis through relapsed or refractory disease."

FLT3 mutations occur in nearly one third of patients with AML and approximately one half of those with an NPM1 mutation. This overlap makes NPM1/FLT3 co-mutated AML an important population for ziftomenib combination development.

Two oral presentations will report preliminary safety and clinical activity findings from ziftomenib combinations with FLT3 inhibitors:

KOMET-007: Ziftomenib plus quizartinib and intensive chemotherapy (7+3) in newly diagnosed NPM1/FLT3-ITD co-mutated AML
KOMET-008: Ziftomenib plus gilteritinib in relapsed or refractory (R/R) NPM1/FLT3 co-mutated AML
A poster presentation from KOMET-007 will provide longer-term follow-up on response durability, overall survival, and safety with ziftomenib plus venetoclax and azacitidine in patients with newly diagnosed NPM1-mutated AML who are ineligible for intensive chemotherapy. These findings support the ongoing global, randomized Phase 3 KOMET-017 registrational study evaluating this combination.

An exploratory analysis from KOMET-001 will describe clinical activity with ziftomenib monotherapy in patients with R/R AML without NPM1 mutations or KMT2A rearrangements whose disease harbors other genomic alterations associated with MEIS1 expression. The findings support further investigation of ziftomenib in additional molecularly defined AML populations.

Two additional oral presentations will feature ziftomenib. The first will report initial results from the PedAL Phase 1 ITCC-101/APAL2020K trial sponsored by Blood Cancer United and Princess Maxima Center evaluating ziftomenib with fludarabine and cytarabine in pediatric R/R acute leukemia. The second will present preclinical findings from additional subsets of menin-associated leukemias.

All eight abstracts related to ziftomenib, including those from investigator-sponsored trials, are available on the ASH (Free ASH Whitepaper) website.

Select 2026 ASH (Free ASH Whitepaper) Presentation Details

Abstract Title Abstract Number Presentation Details
Ziftomenib combined with gilteritinib for relapsed/refractoryNPM1andFLT3co-mutated acute myeloid leukemia (AML): First results from the KOMET-008 phase 1 study
Oral Presentation #66 Session 617
December 12
10:45 a.m. CST
Great Hall AD
Ziftomenib combined with intensive induction (7+3) and quizartinib for newly diagnosedNPM1-m andFLT3-ITD+ acute myeloid leukemia (AML): Preliminary results from KOMET-007
Oral Presentation #902 Session 617
December 14
3:00 p.m. CST
Great Hall BC
Ziftomenib combined with venetoclax/azacitidine in newly diagnosedNPM1-m acute myeloid leukemia (AML): Long-term results from KOMET-007 Poster Presentation #5192 Session 617
December 14
6:00-8:00 p.m. CST
Hall F
Clinical activity of ziftomenib extends beyondNPM1-mutated andKMT2A-rearranged acute myeloid leukemia (AML) intoMEIS1-associated genomic subtypes Poster Presentation #5190 Session 617
December 14
6:00-8:00 p.m. CST
Hall F
Ziftomenib combined with fludarabine and cytarabine in pediatric relapsed/refractory acute leukemia withKMT2Arearrangements,NUP98rearrangements, orNPM1mutations: First results of the phase 1 ITCC-101/APAL2020K trial (NCT06376162)
Oral Presentation #666
Session 616
December 13
5:45 p.m. CST
Hall B
SETBP1-mutant leukemias depend on MENIN-associated KMT2A chromatin complexes to maintain leukemogenic transcriptional programs Oral Presentation #101 Session 636
December 12
10:30 a.m. CST
Hall C

Conference Call and Webcast

Kura will host a webcast and conference call at 8:30 a.m. ET / 5:30 a.m. PT on December 15, 2026, featuring Kura management, Eunice Wang, M.D., Chief of Leukemia Service and Professor of Oncology at Roswell Park Comprehensive Cancer Center, and Amer Zeidan, M.B.B.S., M.H.S., Chief, Division of Hematologic Malignancies and Professor of Medicine at Yale School of Medicine. A live webcast and archived replay of the event will be available in the Investors section of Kura’s website at www.kuraoncology.com.

(Press release, Kura Oncology, NOV 4, 2026, View Source [SID1234674207])