Last update 21 Dec 2024

Bortezomib

Last update 21 Dec 2024

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

[(1R)-3-methyl-1-({(2S)-3-phenyl-2-[(pyrazin-2-ylcarbonyl)amino]propanoyl}amino)butyl]boronic acid, Bortezomib (JAN/USAN/INN), N-[(1R)-1-(DIHYDROXYBORYL)-3-methylbutyl]-N-(pyrazin-2-ylcarbonyl)-L-phenylalaninamide

+ [16]

Target

Proteasome

Mechanism

Proteasome inhibitors

Therapeutic Areas

NeoplasmsImmune System DiseasesCardiovascular Diseases+ [4]

Active Indication

Immunoglobulin Light-Chain AmyloidosisWaldenstrom MacroglobulinemiaMantle-Cell Lymphoma+ [14]

Inactive Indication

Acute Graft Versus Host DiseaseAcute Lymphoblastic LeukemiaAcute myeloid leukaemia with 11q23 abnormality+ [102]

Originator Organization

Millennium Pharmaceuticals, Inc.

Active Organization

Sun Pharmaceutical Industries (Europe) BV

Celgene Corp.Janssen Research & Development LLC

+ [20]

Inactive Organization

Johnson & Johnson Pharmaceutical Research & Development LLC

Spectrum Pharmaceuticals, Inc.

Genentech, Inc.

+ [32]

Drug Highest PhaseApproved

First Approval Date

US (13 May 2003),

Multiple Myeloma

RegulationAccelerated Approval (US), Orphan Drug (EU), Orphan Drug (JP), Orphan Drug (US)

Structure

Molecular FormulaC19H25BN4O4

InChIKeyGXJABQQUPOEUTA-RDJZCZTQSA-N

CAS Registry179324-69-7

1,080

Clinical Trials associated with Bortezomib

NCT06015750 / Not yet recruitingPhase 4

An Interventional, Prospective Open-Label Study of Immunosuppressive Therapies to Mitigate Immune-Mediated Loss of Therapeutic Response to Asfotase Alfa (STRENSIQ®) for Hypophosphatasia (RESTORE)

The primary objective of this study is to evaluate the effect of immunosuppressive therapy (IST) in participants treated with asfotase alfa who demonstrate immune-mediated loss of effectiveness (LoE).

Start Date15 Jan 2025

Sponsor / Collaborator

Alexion Pharmaceuticals, Inc.

NCT05272826 / RecruitingPhase 2IIT

A Single Arm, Response-adapted, Open Label Study of Iberdomide, Weekly Bortezomib and Dexamethasone (IberBd) With Isatuximab Added on Demand for Transplant-ineligible, Newly Diagnosed Multiple Myeloma Patients: the BOREALIS Trial

This study will evaluate efficacy and tolerability of iberdomide, bortezomib, dexamethasone and isatuximab on demand administered in combination.

Start Date01 Jan 2025

Sponsor / Collaborator-

NCT06390319 / Not yet recruitingPhase 2IIT

SJALL23T: Adding Dasatinib Or Venetoclax To Improve Responses In Children With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia (ALL) Or Lymphoma (T-LLY) Or Mixed Phenotype Acute Leukemia (MPAL)

This is a clinical trial testing whether the addition of one of two chemotherapy agents, dasatinib or venetoclax, can improve outcomes for children and young adults with newly diagnosed T-cell acute lymphoblastic leukemia and lymphoma or mixed phenotype acute leukemia.
Primary Objective
* To evaluate if the end of induction MRD-negative rate is higher in patients with T-ALL treated with dasatinib compared to similar patients treated with 4-drug induction on AALL1231.
* To evaluate if the end of induction MRD-negative rate is higher in patients with ETP or near-ETP ALL treated with venetoclax compared to similar patients treated with 4-drug induction on AALL1231.
Secondary Objectives
* To assess the event free and overall survival of patients treated with this therapy.
* To compare grade 4 toxicities, event-free survival (EFS) and overall survival (OS) of patients treated with this therapy in induction and reinduction to toxicities of similar patients treated on TOT17.

Start Date01 Jan 2025

Sponsor / Collaborator

St. Jude Children's Research Hospital, Inc.

[+1]

100 Clinical Results associated with Bortezomib

100 Translational Medicine associated with Bortezomib

100 Patents (Medical) associated with Bortezomib

10,237

Literatures (Medical) associated with Bortezomib

01 Mar 2025·CELLULAR SIGNALLING

tRNA methyltransferase DNMT2 promotes hepatocellular carcinoma progression and enhances Bortezomib resistance through inhibiting TNFSF10

Article

Author: Lai, Junzhong ; Li, Xinxin ; Chen, Zhirong ; Liang, Jiadi ; Chen, Xiaolan ; Lin, Jizhen ; Zhang, Yong ; Zhao, Heng ; Tian, Ling ; Chen, Qi ; Li, Qiumei ; Chen, Linqin ; Guo, Dong ; Zhao, Guangjian ; Fan, Jiqiang

The tRNA methyltransferase DNMT2 (TRDMT1) plays a crucial role in various biological functions; however, its role in cancer, particularly in liver cancer, remains incompletely understood. In this study, we demonstrate that high DNMT2 expression is negatively correlated with prognosis in clinical liver cancer patients. A series of in vitro and in vivo experiments showed that DNMT2 promotes the proliferation, colony formation, and metastasis of hepatocellular carcinoma cells. We identified the pro-apoptotic gene TNFSF10 (TRAIL) as a downstream target of DNMT2, regulated by the N6-methyladenosine (m6A) demethylase FTO. Epigenetically, DNMT2 deletion increased FTO expression, leading to a reduction in m6A methylation levels. FTO upregulated TNFSF10 expression, significantly reducing the proliferation and metastasis of DNMT2-deficient hepatocellular carcinoma cells. Furthermore, DNMT2 deletion was shown to significantly upregulate chemokine expression in tumors. Finally, we demonstrated that the NF-κB inhibitor Bortezomib further enhances DNMT2 deletion-induced apoptosis in hepatocellular carcinoma cells. This study reveals DNMT2's role in liver cancer and presents a new therapeutic target for future treatments.

01 Feb 2025·JOURNAL OF NEUROIMMUNOLOGY

A complex and severe encephalitis associated with four co-existing neuronal cell-surface autoantibodies

Article

Author: Westbrook, Andrew ; Farrell, Michael ; McGuigan, Christopher ; Gilligan, Michael ; O'Donnell, Luke ; Connolly, Sean ; Kinsella, Justin A ; Irani, Sarosh R ; Waters, Patrick ; Riordan, Sean 'o ; Tubridy, Niall

Many forms of autoimmune encephalitis are mediated by neuronal cell-surface directed autoantibodies. The co-occurrence of four neuronal cell-surface antibodies in a single patient is exceptionally rare. We report a patient who had a severe encephalitis associated with antibodies to NMDA, Glycine, GABA_A and GABA_B receptors. Case: A 28-year-old man on tacrolimus presented with a first seizure. Thereafter, he developed confusion, cerebellar signs, opsoclonus, neuromyotonia and medication-refractory seizures. CSF sampling revealed 826 white cells and NMDA, glycine and GABA_B receptor antibodies: all were also detected in serum along with additional GABA_A receptor antibodies. Neural antibodies were detected using fixed (NMDA, GABA_A, GABA_B receptor) or live (glycine receptor) cell-based assays at Oxford Neuroimmunology Laboratory, Oxford, UK. MRI brain demonstrated cerebellar leptomeningeal enhancement and a hyperintense lesion in the cerebellar vermis. EEG revealed extreme delta brush and needle EMG confirmed neuromyotonia. No underlying malignancy was detected. Methylprednisolone, IVIG, Rituximab, therapeutic plasma exchange, cyclophosphamide and bortezomib were administered sequentially, with minimal clinical improvement. Death secondary to respiratory sepsis occurred on the 714th hospital day. Postmortem revealed pan-cerebellar atrophy with Purkinje cell loss; dentate nucleus ganglionopathy, and thoracolumbar cord myelopathy. In summary, the detection of multiple neuronal cell-surface antibodies in autoimmune encephalitis is unusual and may result in a complex overlap syndrome with a poor response to immunotherapy.

01 Jan 2025·TALANTA

Design of a molecularly imprinted polymer sensor modified with saffron-based copper nanoflowers for highly selective and sensitive determination of bortezomib

Article

Author: Baldemir Kilic, Ayse ; Kaya, S Irem ; Atici, Esen Bellur ; Yusufbeyoglu, Sadi ; Cetinkaya, Ahmet ; Kilic, Ayse Baldemir ; Ozkan, Sibel A ; Ozkan, Sibel A. ; Kaya, S. Irem

This work represents the first successful application of a molecularly imprinted polymer (MIP)-based electrochemical sensor for the sensitive and selective determination of the first developed proteasome inhibitor, bortezomib (BOR). BOR is used for the treatment of multiple myeloma, gastrointestinal stromal tumors, and mantle cell lymphoma. It shows its desired effect through the boronate group and can be administered intravenously or subcutaneously. The MIP-based electrochemical sensor design includes the integration of green-synthesized saffron-based copper nanoflowers (CuNFs) from Crocus sativus L. to increase the active surface area and porosity of the glassy carbon electrode (GCE) surface. 2-Acrylamido-2-methyl-1-propanesulfonic acid (AMPS) was selected as the functional monomer along with other MIP components. Detailed characterizations of the developed CuNFs/AMPS/MIP-GCE sensor and CuNFs were performed using scanning electron microscopy (SEM), X-ray diffraction (XRD), Fourier transform infrared spectroscopy (FTIR), energy dispersive X-ray analysis (EDX), cyclic voltammetry (CV), and electrochemical impedance spectroscopy (EIS). The indirect measurement approach using 5.0 mM [Fe(CN)₆]^3-/4- solution was used to determine BOR in the linear range of 2.5 × 10^-13 M - 2.5 × 10^-12 M (0.25-2.5 pM). The LOD and LOQ values of the sensor obtained at the fM level (29 fM and 96.7 fM), which has a linear response in the commercial human serum sample in the same concentration range, emphasize its sensitivity (1.89 × 10¹³ and 2.14 × 10¹³ μA/M for standard solution and serum). The repeatability and reproducibility of the sensor were between 0.87 % and 2.17 %, showing its reliability. The successful performance of the sensor in the presence of metabolites belonging to BOR demonstrates its unique selectivity. The selectivity was demonstrated via relative imprinting factor (IF') values (higher than 3.5) against BOR's metabolites. The stability of the CuNFs/AMPS/MIP-GCE sensor was found to be 5 days.

360

News (Medical) associated with Bortezomib

13 Dec 2024

·www.globenewswire.com

CARVYKTI® Significantly Improved Minimal Residual Disease Negativity Compared to Standard of Care for Patients with Relapsed or Refractory Multiple Myeloma

89 percent of evaluable patients achieved minimal residual disease (MRD) negativity with CARVYKTI® after three-year follow-up in CARTITUDE-4 study; the majority in less than 2 months Results add to the overall survival (OS) benefit recently reported making CARVYKTI® the first and only cell therapy to significantly extend OS versus standard therapies in multiple myeloma Landmark Phase 3 CARTITUDE-4 study data featured as an oral presentation at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition Dec. 09, 2024 -- Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global leader in cell therapy, announced today new results from the Phase 3 CARTITUDE-4 study that show a single infusion of CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) provided significantly higher rates of minimal residual disease (MRD)-negativity in patients with relapsed or lenalidomide-refractory multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD, compared to standard therapies of pomalidomide, bortezomib, and dexamethasone (PVd) or daratumumab, pomalidomide, and dexamethasone (DPd).1 MRD negativity is a prognostic marker of prolonged survival outcomes for patients with multiple myeloma.1 These results reinforce the clinical value of CARVYKTI® as early as second line and support the recent achievement of overall survival (OS) benefit versus standard therapies1. The MRD negativity findings were featured as an oral presentation at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition (Abstract #1032) in San Diego, California.1 “The MRD data further underscores the benefits of treatment with CARVYKTI,” said Yi Lin, M.D., Ph.D., hematologist and oncologist at Mayo Clinic, Rochester, MN. “These new findings support CARVYKTI as a transformative therapeutic option, leading to improved progression-free survival, overall survival, and now minimal residual disease negativity.” ‡ The Phase 3 CARTITUDE-4 study evaluated CARVYKTI® in comparison to standard therapies of PVd or DPd for the treatment of adults with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy, including a PI and IMiD, and who were lenalidomide-refractory. In the trial, 208 adults were randomized to receive CARVYKTI®, and 211 to receive standard therapies. The study assessed patients for MRD negativity at the 10-5 threshold (cilta-cel, n=145, standard therapies, n=103). At a median follow-up of almost three years (34 months), evaluable patients treated with CARVYKTI® achieved an MRD-negativity rate of 89% versus 38% for those treated with standard therapies (P® with 69% of MRD-evaluable patients by day 56. At data cutoff, sustained MRD-negative ≥CR of at least 12 months was achieved in 52% of MRD-evaluable patients in the CARVYKTI® arm vs. 10% in the standard of care arm (P® was administered earlier in the treatment regimen. “The latest MRD data showcases the advances of CARVYKTI and further demonstrates why it is a leading treatment for patients with multiple myeloma,” said Ying Huang, Ph. D., Chief Executive Officer of Legend Biotech. “As we strive to transform the therapeutic landscape in cancer and beyond, we are proud of the progress made and will continue our efforts to improve the quality of life for those battling incurable diseases.” Data from CARTITUDE-4 supported the U.S. Food and Drug Administration (FDA) and European Commission (EC) approval of CARVYKTI® earlier this year for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy, including a PI, and IMiD, and are refractory to lenalidomide.1 CARVYKTI® is the first and only BCMA-targeted CAR-T cell therapy approved for the treatment of patients with multiple myeloma who have had at least one prior line of therapy. Globally, CARVYKTI® is now commercially available in five countries and has been utilized by over 4,500 patients. Ciltacabtagene autoleucel is a BCMA-directed, genetically modified autologous T-cell immunotherapy, which involves reprogramming a patient’s own T-cells with a transgene encoding a chimeric antigen receptor (CAR) that identifies and eliminates cells that express BCMA. The cilta-cel CAR protein features two BCMA-targeting single domain antibodies designed to confer high avidity against human BCMA. Upon binding to BCMA-expressing cells, the CAR promotes T-cell activation, expansion, and elimination of target cells.2 In December 2017, Legend Biotech entered into an exclusive worldwide license and collaboration agreement with Janssen Biotech, Inc. (Janssen), a Johnson & Johnson company, to develop and commercialize cilta-cel. In February 2022, cilta-cel was approved by the U.S. Food and Drug Administration (FDA) under the brand name CARVYKTI® for the treatment of adults with relapsed or refractory multiple myeloma. In April 2024, cilta-cel was approved for the second-line treatment of patients with relapsed/refractory myeloma who have received at least one prior line of therapy including a proteasome inhibitor, an immunomodulatory agent, and are refractory to lenalidomide. In May 2022, the European Commission (EC) granted conditional marketing authorization of CARVYKTI® for the treatment of adults with relapsed or refractory multiple myeloma. In September 2022, Japan’s Ministry of Health, Labour and Welfare (MHLW) approved CARVYKTI®. Cilta-cel was granted Breakthrough Therapy Designation in the U.S. in December 2019 and in China in August 2020. In addition, cilta-cel received a PRIority MEdicines (PRIME) designation from the European Commission in April 2019. Cilta-cel also received Orphan Drug Designation from the U.S. FDA in February 2019, from the European Commission in February 2020, and from the Pharmaceuticals and Medicinal Devices Agency (PMDA) in Japan in June 2020. In March 2022, the European Medicines Agency’s Committee for Orphan Medicinal Products recommended by consensus that the orphan designation for cilta-cel be maintained on the basis of clinical data demonstrating improved and sustained complete response rates following treatment. CARTITUDE-4 (NCT04181827) is an ongoing, international, randomized, open-label Phase 3 study evaluating the efficacy and safety of cilta-cel versus pomalidomide, bortezomib and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd) in adult patients with relapsed or lenalidomide-refractory multiple myeloma who received one to three prior lines of therapy, including a PI and an IMiD.3 Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterized by an excessive proliferation of plasma cells.4 In 2024, it is estimated that more than 35,000 people will be diagnosed with multiple myeloma, and more than 12,000 people will die from the disease in the U.S.5 While some patients with multiple myeloma initially have no symptoms, most patients are diagnosed due to symptoms that can include bone problems, low blood counts, calcium elevation, kidney problems or infections.6 Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogeneic chimeric antigen receptor T-cell, gamma-delta T cell (gd T) and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of cutting-edge therapeutics for patients worldwide. REFERENCES ____________________________________ 1 Rakesh Popat et al. Ciltacabtagene Autoleucel (Cilta-cel) Vs Standard of Care (SoC) in Patients with Lenalidomide (Len)-Refractory Multiple Myeloma (MM) after 1-3 Lines of Therapy: Minimal Residual Disease (MRD) Negativity in the Phase 3 Cartitude-4 Trial. American Society of Hematology 2024 Annual Meeting. December 2024 2 CARVYKTI™ Prescribing Information. Horsham, PA: Janssen Biotech, Inc. 3 ClinicalTrials.Gov. A Study Comparing JNJ-68284528, a CAR-T Therapy Directed Against B-cell Maturation Antigen (BCMA), Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Participants With Relapsed and Lenalidomide-Refractory Multiple Myeloma (CARTITUDE-4). https://www.clinicaltrials.gov/study/NCT04181827. Accessed March 2024. 4 American Cancer Society. ”What is Multiple Myeloma?”. Available at: https://www.cancer.org/cancer/types/multiple-myeloma/about/what-is-multiple-myeloma.html. Accessed March 2024. 5 American Cancer Society. “Key Statistics About Multiple Myeloma.” Available at: https://www.cancer.org/cancer/types/multiple-myeloma/about/key-statistics.html. Accessed March 2024 6 American Cancer Society. Multiple myeloma: early detection, diagnosis, and staging. Available at: https://www.cancer.org/content/dam/CRC/PDF/Public/8740.00.pdf. Accessed March 2023. 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$CARVYKTI® Significantly Improved Minimal Residual Disease Negativity Compared to Standard of Care for Patients with Relapsed or Refractory Multiple Myeloma$

Clinical ResultDrug ApprovalASHCell Therapy

10 Dec 2024

·pipelinereview.com

Belantamab Mafodotinshows significant overall survival benefit, reducing the risk of death by 42% in multiple myeloma at or after first relapse

PHILADELPHIA, PA, USA I December 09, 2024 I GSK plc (LSE/NYSE: GSK) today announced statistically significant and clinically meaningful overall survival (OS) results from a planned interim analysis of the DREAMM-7 trial evaluating belantamab mafodotin in combination with bortezomib plus dexamethasone (BVd) versus daratumumab in combination with bortezomib plus dexamethasone (DVd) as a second line or later treatment for relapsed or refractory multiple myeloma. These data were featured today in an oral presentation at the 66 th American Society of Hematology (ASH) Annual Meeting and Exposition. The OS findings from DREAMM-7 build on previous data from the DREAMM-7 1 and DREAMM-8 2 trials, which showed a statistically significant and clinically meaningful improvement in progression-free survival (PFS) for both belantamab mafodotin-based combinations versus standard of care comparators. Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK, said: “The compelling overall survival data from the DREAMM-7 trial establish the potential of belantamab mafodotin in combination to significantly extend the lives of patients with multiple myeloma at or after first relapse. This represents an important advancement that could redefine the treatment of relapsed or refractory multiple myeloma.” With a median follow up of 39.4 months, the analysis presented today shows a statistically significant 42% reduction in the risk of death among patients receiving the belantamab mafodotin combination (n=243) versus the daratumumab-based comparator (n=251) (HR 0.58; 95% CI: 0.43-0.79; p=0.00023). Although the median overall survival (mOS) was not reached in either arm of the study, the projected mOS for BVd is 84 months compared to 51 months for DVd. 3 The three-year OS rate was 74% in the belantamab mafodotin combination arm and 60% in the daratumumab combination arm. The survival benefit favoring BVd was seen as early as four months and was sustained over time as illustrated by the separation of the lines in the Kaplan-Meier curve shown above. María-Victoria Mateos, MD, PhD, Head of Myeloma and Clinical Trials Unit, Hematology Department and Professor of Medicine at the University of Salamanca, Spain, and DREAMM-7 principal investigator, said : “The totality of evidence from DREAMM-7 represents a potential paradigm shift for multiple myeloma patients who have experienced a relapse or become refractory to initial treatment. The OS results shown with the belantamab mafodotin combination in DREAMM-7 further cement the potential of this regimen to prolong the lives of patients with relapsed or refractory multiple myeloma compared to a standard of care daratumumab combination.” The belantamab mafodotin combination also showed statistically significant superiority on the key secondary endpoint of minimal residual disease (MRD) negativity (no detectable cancer cells) compared to the daratumumab combination. The greater than 2.5-fold improvement in the rate of MRD negativity seen at the time of the primary analysis for patients who received BVd can now be declared as statistically significant (p<0.00001) after the positive OS readout based on the predefined testing procedure. This further underscores the transformative potential of this belantamab mafodotin combination for multiple myeloma patients at or after their first relapse. In addition to OS and MRD negativity, the belantamab mafodotin combination resulted in clinically meaningful improvements in all key secondary efficacy endpoints compared to the daratumumab combination, including duration of response (DOR) and progression-free survival 2 (PFS 2). The results indicate deeper and more durable responses among patients treated with BVd compared to DVd. The safety and tolerability of the belantamab mafodotin regimen were consistent with the primary analysis and known safety profile of the individual agents. Grade 3 or higher adverse events of clinical interest in the belantamab mafodotin combination and daratumumab combination arms, respectively included thrombocytopenia (56% versus 35%; 34 versus 25 patients/100 person-years); anemia (9% versus 10%; exposure-adjusted rate [per 100 person-years] not reported); and neutropenia (14% versus 10%; 8 versus 7 patients/100 person-years). Eye-related side effects, a known risk of treatment with belantamab mafodotin, were generally manageable and resolvable with dose modification, and led to a low (10%) treatment discontinuation rate. Full data summaries for OS and other key secondary endpoints are shown below. In 2024, regulatory filings for belantamab mafodotin combinations for the treatment of relapsed or refractory multiple myeloma based on the results of the DREAMM-7 and DREAMM-8 trials have been accepted in the US 4 , European Union 5 , Japan 6 (with priority review), China (for DREAMM-7 only, with priority review; Breakthrough Therapy Designation 7 also granted), United Kingdom, Canada and Switzerland (with priority review for DREAMM-8). About the DREAMM clinical development program The DREAMM (DRiving Excellence in Approaches to Multiple Myeloma) clinical development program continues to evaluate the potential of belantamab mafodotin in early lines of treatment and in combination with novel therapies and standard of care treatments. In addition to DREAMM-7 and DREAMM-8, a phase III study in newly diagnosed transplant ineligible multiple myeloma, DREAMM-10, is expected to be initiated by the end of 2024. About DREAMM-7 The DREAMM-7 phase III clinical trial is a multi-center, open-label, randomized trial evaluating the efficacy and safety of belantamab mafodotin in combination with bortezomib plus dexamethasone (BVd) compared to a combination of daratumumab and bortezomib plus dexamethasone (DVd) in patients with relapsed/refractory multiple myeloma who previously were treated with at least one prior line of multiple myeloma therapy, with documented disease progression during or after their most recent therapy. A total of 494 participants were randomized at a 1:1 ratio to receive either BVd or DVd. Belantamab mafodotin was scheduled to be dosed at 2.5mg/kg intravenously every three weeks. The primary endpoint is PFS as per an independent review committee. The key secondary endpoints include OS, duration of response (DOR), and minimal residual disease (MRD) negativity rate as assessed by next-generation sequencing. Other secondary endpoints include overall response rate (ORR), safety, and patient reported and quality of life outcomes. Results from DREAMM-7 were first presented 1 at the American Society of Clinical Oncology (ASCO) Plenary Series in February 2024, shared in an encore presentation at the 2024 ASCO Annual Meeting, and published in the New England Journal of Medicine . About multiple myeloma Multiple myeloma is the third most common blood cancer globally and is generally considered treatable but not curable. 8,9 There are approximately more than 180,000 new cases of multiple myeloma diagnosed globally each year. 10 Research into new therapies is needed as multiple myeloma commonly becomes refractory to available treatments. 11 Many patients with multiple myeloma, including approximately 65% in the US, are treated in a community cancer setting, leaving an urgent need for new, effective therapies with manageable side effects that can be administered outside of an academic center. 12,13,14 About belantamab mafodotin Belantamab mafodotin is an investigational antibody-drug conjugate comprising a humanized B-cell maturation antigen monoclonal antibody conjugated to the cytotoxic agent auristatin F via a non-cleavable linker. The drug linker technology is licensed from Seagen Inc.; the monoclonal antibody is produced using POTELLIGENT Technology licensed from BioWa Inc., a member of the Kyowa Kirin Group. GSK in oncology Oncology is an emerging therapeutic area for GSK where we are committed to maximizing patient survival with a current focus on hematologic malignancies, gynecologic cancers and other solid tumors through breakthroughs in immuno-oncology and tumor-cell targeting therapies. About GSK GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at us.gsk.com . SOURCE: GlaxoSmithKline

Clinical ResultPhase 3ASCOBreakthrough TherapyPriority Review

10 Dec 2024

·www.prnewswire.com

Antengene Presents Results from Two Late-Stage Clinical Studies of Selinexor at ASH 2024

SHANGHAI and HONG KONG, Dec. 9, 2024 /PRNewswire/ -- Antengene Corporation Limited ( "Antengene", SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for hematologic malignancies and solid tumors, today announced that it presented the latest data from two clinical studies of selinexor in two posters at the 2024 American Society of Hematology Annual Meeting (ASH 2024). Details on the Posters: Title: Weekly Selinexor, Bortizomib and Dexamethasone (SVd) Versus Twice Weekly Bortizomib and Dexamethasone (Vd) in Chinese Patients with Relapsed and Refractory Multiple Myeloma (RRMM): Primary Analysis of Phase III Bench Study Publication Number: 4748 Session: 654. Multiple Myeloma: Pharmacologic Therapies: Poster III Date: Monday, December 9, 2024 Time: 6:00 PM - 8:00 PM (Pacific time) 10:00 AM - 12:00 PM, December 10, 2024 (Beijing time) The BENCH study is a Phase III randomized, open-label, multicenter clinical trial, aiming to evaluate the efficacy and safety of selinexor, bortezomib and dexamethasone (SVd) regimen against bortezomib and dexamethasone (Vd) regimen in Chinese adult patients with R/R MM who have received one to three prior lines of therapy. At present, a New Drug Application (NDA) based this study has already been submitted to and accepted by China's National Medical Products Administration (NMPA). As of May 9, 2024, a total of 154 Chinese R/R MM patients were randomized to SVd group (n=101) or Vd group (n=53) and 152 patients received at least one dose of study drug (safety population). Efficacy results showed that the median progression-free survival (mPFS) was 8.1 months with SVd group and 6.3 months with Vd group. The overall response rate (ORR) was higher in SVd group than in Vd group. SVd group had a significantly higher proportion of patients with a very good partial response (VGPR) or better responses. The median time to response and the median duration of response were 0.8 vs 1.4 months and 9.7 vs 7.2 months (SVd vs Vd), respectively. During the study, some subjects experienced treatment emergent adverse events (TEAEs). The most frequent Grade 3-4 adverse events (AEs) for SVd and Vd (≥10%) included thrombocytopenia, lymphocytopenia, and anemia. The incidence of Grade≥2 peripheral neuropathy (PN) was significantly lower in SVd than in Vd group. The BENCH study has met its primary and key secondary endpoints, with results consistent with the BOSTON study. These results showed that the SVd regimen decreased the risk of progression and obtained much more profound responses compared to standard Vd regimen in Chinese patients with R/R MM. The incidence of Grade ≥2 PN were significantly reduced. Title: Selinexor Combined with Tislelizumab in Patients with Relapsed or Refractory Extranodal NK/T-Cell Lymphoma (R/R ENKTL): Preliminary Results of Arm C, from a Multicenter, Single-Arm, Phase I/II Study, Touch Publication Number: 4448 Session: 625. T Cell, NK Cell, or NK/T Cell Lymphomas: Clinical and Epidemiological: Poster III Date: Monday, December 9, 2024 Time: 6:00 PM - 8:00 PM (Pacific time) 10:00 AM - 12:00 PM, December 10, 2024 (Beijing time) The Phase I/II TOUCH study is investigating selinexor combined with different drugs in R/R ENKTL. Arm C of the study aims to evaluate the safety, tolerability and preliminary efficacy of selinexor in combination with anti-PD-1 antibody tislelizumab. As of 18 May 2024, 17 R/R ENKTL patients were enrolled in Arm C [Sel 40mg (n=3); Sel 60mg (n=14)]. Sixteen patients previously exposed to both L-asparaginase (L-Asp) and checkpoint inhibitors (CPIs) including 8 patients who had received prior Tislelizumab (Tis); eleven (64.7%) patients were refractory to their last-line therapy. Efficacy results showed that, of 16 CPIs exposed patients (one patient was efficacy non-evaluable), the ORR was 75% (12/16), including 7 CRs and 5 PRs; and the median PFS was 6.7 months (95% CI 1.5, NE). During the study, all patients experienced TEAEs. The most common TEAEs included anemia, neutropenia, asthenia, decreased appetite, weight loss, and thrombocytopenia. Ten patients (58.8%) experienced Grade≥3 TEAEs. Treatment emergent serious adverse events (TESAEs) occurred in 4 patients (23.5%), of which two were considered treatment related. No patient discontinued due to TEAEs. Most of toxicities were manageable by dose modification and supportive care. In the study, the chemo-free regimen, Sel plus Tis, showed a favorable response rate and manageable safety profile in R/R ENKTL. This approach may probably reverse drug resistance in ENKTL that has progressed after prior CPI treatment. About Antengene Antengene Corporation Limited ( "Antengene", SEHK: 6996.HK) is a leading commercial-stage R&D-driven global biopharmaceutical company focused on the discovery, development, manufacturing and commercialization of innovative first-in-class/best-in-class therapeutics for the treatment of hematologic malignancies and solid tumors, in realizing its vision of "Treating Patients Beyond Borders". Since 2017, Antengene has built a pipeline of 9 oncology assets at various stages going from clinical to commercial, including 6 with global rights, and 3 with rights for the APAC region. To date, Antengene has obtained 31 investigational new drug (IND) approvals in the U.S. and Asia, and submitted 10 new drug applications (NDAs) in multiple Asia Pacific markets, with the NDA for XPOVIO® (selinexor) already approved in Mainland of China, Taiwan China, Hong Kong China, Macau China, South Korea, Singapore, Malaysia, Thailand and Australia. Forward-looking statements The forward-looking statements made in this article relate only to the events or information as of the date on which the statements are made in this article. Except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. In this article, statements of, or references to, our intentions or those of any of our Directors or our Company are made as of the date of this article. Any of these intentions may alter in light of future development. For a further discussion of these and other factors that could cause future results to differ materially from any forward-looking statement, please see the other risks and uncertainties described in the Company's Annual Report for the year ended December 31, 2023, and the documents subsequently submitted to the Hong Kong Stock Exchange. For more information, please contact: Investor Contacts: Donald Lung E-mail: [email protected] Mobile: +86 18420672158 PR Contacts: Peter Qian E-mail: [email protected] Mobile: +86 13062747000 SOURCE Antengene Corporation Limited WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultPhase 3NDADrug ApprovalASH

100 Deals associated with Bortezomib

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KEGG	Wiki	ATC	Drug Bank
D03150	Bortezomib	L01XX32	DB00188

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Immunoglobulin Light-Chain Amyloidosis	JP	Janssen Pharmaceutical KK	20 Oct 2006
Waldenstrom Macroglobulinemia	JP	Janssen Pharmaceutical KK	20 Oct 2006
Mantle-Cell Lymphoma	EU	Janssen-Cilag International NV	26 Apr 2004
Mantle-Cell Lymphoma	IS	Janssen-Cilag International NV	26 Apr 2004
Mantle-Cell Lymphoma	LI	Janssen-Cilag International NV	26 Apr 2004
Mantle-Cell Lymphoma	NO	Janssen-Cilag International NV	26 Apr 2004
Multiple Myeloma	US	Takeda Pharmaceuticals U.S.A., Inc.	13 May 2003

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Diffuse large B-cell lymphoma recurrent	Phase 3	IT	Janssen-Cilag Ltd.	04 Feb 2013
Diffuse large B-cell lymphoma recurrent	Phase 3	IT	Janssen Pharmaceutica NV	04 Feb 2013
Diffuse large B-cell lymphoma refractory	Phase 3	IT	Janssen Pharmaceutica NV	04 Feb 2013
Diffuse large B-cell lymphoma refractory	Phase 3	IT	Janssen-Cilag Ltd.	04 Feb 2013
Plasma Cell Leukemia	Phase 3	CN	Janssen Scientific Affairs LLC	13 Jan 2012
Plasma Cell Leukemia	Phase 3	AU	Janssen Scientific Affairs LLC	13 Jan 2012
Plasma Cell Leukemia	Phase 3	KR	Janssen Scientific Affairs LLC	13 Jan 2012
Diffuse Large B-Cell Lymphoma	Phase 3	CH	Janssen-Cilag Ltd.	01 Apr 2011
Diffuse Large B-Cell Lymphoma	Phase 3	GB	Janssen-Cilag Ltd.	01 Apr 2011
B-Cell Lymphoma	Phase 3	US	Millennium Pharmaceuticals, Inc.	01 Mar 2006

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04246047 (DREAMM-7, ASH2024) Manual	Phase 3	Multiple Myeloma	494	Belantamab mafodotin, bortezomib, and dexamethasone (BVd)	qkgvhojaqq(ncekqlfqhf) = tjshdqfubx itucowsspp (jvnglochpv, 28.4 - NR) Met View more	Positive	09 Dec 2024
NCT04246047 (DREAMM-7, ASH2024) Manual	Phase 3	Multiple Myeloma	494	Daratumumab, bortezomib, and dexamethasone (DVd)	qkgvhojaqq(ncekqlfqhf) = cqlfalqqys itucowsspp (jvnglochpv, 11.1 - 17.5) Met View more	Positive	09 Dec 2024
NCT03319667 (IMROZ, ASH2024) Manual	Phase 3	Multiple Myeloma First line	446	Isatuximab, Bortezomib, Lenalidomide, and Dexamethasone (Isa-VRd)	xqncknnmvo(nnebmoidfr) = sywdeswbut ehbmizezto (vgsmyqorde ) View more	Positive	09 Dec 2024
NCT03319667 (IMROZ, ASH2024) Manual	Phase 3	Multiple Myeloma First line	446	Bortezomib, Lenalidomide, and Dexamethasone (VRd)	xqncknnmvo(nnebmoidfr) = qumaoosczi ehbmizezto (vgsmyqorde ) View more	Positive	09 Dec 2024
NCT03620903 (ECWM-2, ASH2024) Manual	Phase 2	Waldenstrom Macroglobulinemia First line	53	Bortezomib+Ibrutinib+Rituximab	rgsxlkpnxi(gocwejtaoc) = wwdixlomdw mfbroglynm (uirahbmics ) View more	Positive	09 Dec 2024
ASH2024	Not Applicable	Multiple Myeloma	-	Ixazomib-lenalidomide-dexamethasone (IRd)	awlgvkgrdi(fdlukymxgc) = Any grade TEAEs reported in ≥25% of pts were diarrhea (26%) in the 1−3 cycles group; PN not elsewhere classified (NEC; 34%), fatigue (34%), diarrhea (34%), and edema NEC (26%) in the 4−9 cycles group; and diarrhea (68%), PN NEC (53%), fatigue (42%), edema NEC (38%), arthralgia (35%), nausea (33%), and back pain (29%) in the >9 cycles group. bqkrnensop (tllnwsoplh ) View more	-	09 Dec 2024
NCT03617731 (GMMG-HD7, ASH2024)	Phase 3	Multiple Myeloma CD38	662	Isatuximab, Lenalidomide, Bortezomib, Dexamethasone	vjpcjrynim(lagkqmhbsb) = mgwxlwwiwe tiqolqczdx (sagkdxturu, 95% CI 0.52 - 0.94) View more	Positive	09 Dec 2024
NCT03617731 (GMMG-HD7, ASH2024)	Phase 3	Multiple Myeloma CD38	662	Lenalidomide, Bortezomib, Dexamethasone	vjpcjrynim(lagkqmhbsb) = kwzklcxpgs tiqolqczdx (sagkdxturu, 95% CI 46 - 48) View more	Positive	09 Dec 2024
ASH2024	Not Applicable	Multiple Myeloma	-	Pomalidomide, Bortezomib, Dexamethasone	ejgakqgcox(qlnhaydaju) = achfamtdyn tkpkwvrldf (rqnaqyisxz ) View more	-	09 Dec 2024
CASTOR (ASH2024)	Phase 3	Multiple Myeloma	-	Daratumumab/bortezomib/dexamethasone (DVd)	qmgeawclmm(swpfxocmbv) = vmjutduqdk ivreauowjk (dcpyuifsze, 48.5 - 56.2) View more	Positive	08 Dec 2024
ASH2024	Not Applicable	Multiple Myeloma	-	Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone (DVRd)	cicjdiiacl(izzcxsuzng) = wawgelcvmu hnktrwdvpz (bcewvdiuyy ) View more	-	08 Dec 2024
ASH2024	Not Applicable	Multiple Myeloma	-	DVRd-DR	cicjdiiacl(izzcxsuzng) = nsnrwvqlsw hnktrwdvpz (bcewvdiuyy ) View more	-	08 Dec 2024
ASH2024	Not Applicable	Multiple Myeloma	-	Daratumumab, Lenalidomide, Bortezomib, Dexamethasone (D-RVd)	xvskyocjun(pmyglewvcv) = 82% rwhbkhlrys (vywxruwkjt ) View more	-	08 Dec 2024
ASH2024	Not Applicable	Multiple Myeloma	-	Selinexor 40 mg QW + Lenalidomide 25mg + Dexamethasone 20mg	cxfwxlpyar(ftefcncfpn) = Grade 3 events included: Anxiety (N=1) yqdozmzvus (ongkfexkdt ) View more	-	07 Dec 2024

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