A Phase 3, Randomized, Open-label, Multicenter Trial to Evaluate the Safety and Efficacy of Quadruplet Induction Followed by Anitocabtagene Autoleucel Versus Standard of Care Therapy in Participants With Newly Diagnosed Multiple Myeloma Who Are Not Eligible for Autologous Stem Cell Transplant

The goal of this clinical study iMMagine-4 is to compare and assess the safety and effectiveness of anitocabtagene autoleucel versus standard of care therapy (SOCT) in participants with newly diagnosed multiple myeloma (NDMM) who are not eligible for autologous stem cell transplant.
The primary objective of this study is to compare the efficacy of anitocabtagene autoleucel versus quadruplet-based SOCT in participants with NDMM who are not eligible for autologous stem cell transplant (auto-SCT).

Start Date01 Jan 2027

Sponsor / Collaborator

Kite Pharma, Inc.

NCT07887984

/ Not yet recruitingPhase 2/3IIT

Bispecific Antibody Therapy vs Autologous Stem Cell Transplantation as Consolidation for Newly Diagnosed, Standard Risk Multiple Myeloma

This phase II/III trial compares the usual treatment (daratumumab and hyaluronidase, lenalidomide, bortezomib and dexamethasone [DaraRVd] regimen followed by autologous stem cell transplant [ASCT] followed by maintenance therapy) to DaraRVd treatment followed by bispecific antibody therapy (teclistamab and/or talquetamab) followed by maintenance therapy in treating patients with newly diagnosed, standard risk multiple myeloma. Daratumumab is in a class of medications called monoclonal antibodies. Daratumumab and hyaluronidase works by helping the body to slow or stop the growth of cancer cells. Hyaluronidase is an endoglycosidase. It helps to keep daratumumab in the body longer so that the medication will have a greater effect. Lenalidomide is in a class of medications called immunomodulatory agents. It works by helping the bone marrow to produce normal blood cells and by killing abnormal cells in the bone marrow. Bortezomib blocks several molecular pathways in a cell and may cause cancer cells to die. It is a type of proteasome inhibitor and a type of dipeptidyl boronic acid. Dexamethasone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Teclistamab and talquetamab are bispecific monoclonal antibodies that can bind to targets on both cancer cells and immune cells (T-cells) that may help the body's immune system attack the cancer, and may interfere with the ability of cancer cells to grow and spread. Giving DaraRVd followed by teclistamab and/or talquetamab may work better in increasing the likelihood of reducing the cancer burden to the point that it is undetectable, and prolonging the time until the cancer returns compared to DaraRVd followed by ASCT.

Start Date23 Dec 2026

Sponsor / Collaborator

Alliance for Clinical Trials in Oncology

[+1]

NCT07600151

/ Not yet recruitingPhase 1/2IIT

A Clinical Phase I/II, Multicenter, Open-label, National Study Evaluating Quintuplet Treat-ment With ISaTuximab, Bortezomib, Lenalidomide and Dexamethasone Plus Etentamig (Etenta-Isa-VRd) in Primary DiagnOsed High-Risk Multiple Myeloma Patients

This study is researching an experimental five-drug combination called etentamig, isatuximab, bortezomib, lenalidomide, and dexamethasone. The study is focused on participants with newly diagnosed multiple myeloma (NDMM) and high-risk disease who are eligible for autologous stem cell transplantation.

Start Date01 Dec 2026

Sponsor / Collaborator

Universitätsklinikum Hamburg-Eppendorf

[+2]

100 Clinical Results associated with Bortezomib

100 Translational Medicine associated with Bortezomib

100 Patents (Medical) associated with Bortezomib

12,686

Literatures (Medical) associated with Bortezomib

01 May 2027·Value in Health Regional Issues

Cost-Effectiveness Analysis of Carfilzomib vs Bortezomib in Relapsed/Refractory Multiple Myeloma in Iran

Article

Author: Raeis Zadeh, Mohammad Mahdi ; Fatemi, Behzad ; Mashreghi Mohammadi, Neshaut ; Nikfar, Shekoufeh

OBJECTIVES:

Multiple myeloma, the second most common hematologic malignancy, primarily affects older adults. Proteasome inhibitors such as carfilzomib and bortezomib are key treatment options. Because of high costs, disease progression, and differences in drug outcomes, cost-effectiveness evaluations are crucial for healthcare policy.

METHODS:

A model-based cost-effectiveness study was conducted using Partitioned Survival Analysis with clinical and quality-of-life data from the ENDEAVOR trial. A societal perspective and 20-year time horizon were applied, encompassing direct medical, nonmedical, and indirect costs, refined through expert consultation. Treatment effectiveness was measured using quality-adjusted life-years (QALYs), whereas incremental cost-effectiveness ratio was applied to determine cost-effectiveness. Costs and outcomes beyond the first year were discounted annually at 5.8% and 5%, respectively. The willingness-to-pay threshold was set at $6065.57 (1 Iranian gross domestic product/capita). To address model uncertainty, tornado diagrams, 1-way sensitivity analyses, and Monte Carlo simulations were performed.

RESULTS:

Carfilzomib was not cost-effective relative to bortezomib in treating relapsed/refractory multiple myeloma in Iran. Total treatment cost for carfilzomib reached $100 139.98 compared with $31 100.49 for bortezomib. Carfilzomib achieved higher health gains, with 3.43 QALYs vs 2.94 QALYs. However, its incremental cost was $69 039.49, yielding an incremental cost-effectiveness ratio of $139 206.61 per QALY gained.

CONCLUSION:

In the treatment of relapsed/refractory multiple myeloma in Iran, Carfilzomib demonstrates greater clinical effectiveness than Bortezomib but is associated with substantially higher costs. Despite its improved health outcomes, Carfilzomib does not meet cost-effectiveness criteria at current market prices.

01 Mar 2027·Value in Health Regional Issues

Cost-Minimization Analysis of Intravenous and Subcutaneous Daratumumab in Patients With Multiple Myeloma: A Societal and Healthcare System Perspective

Article

Author: Fantelli, Valentina ; Temporin, Francesca ; Venturini, Francesca ; Riccoboni, Debora ; Zambello, Renato ; Berti, Giacomo

OBJECTIVES:

We compared costs of daratumumab (DARA) subcutaneous (SC) versus intravenous (IV) from societal and healthcare system perspectives.

METHODS:

We performed a cost-minimization analysis over 24 months using real-world weight distribution data from 304 patients treated in 2024. IV drug costs were weighted by patient distribution across 14 weight categories (6.25 kg intervals). We analyzed 4 patient scenarios (employed/unemployed, with/without caregiver) and 2 regimens (DARA-lenalidomide-dexamethasone, DARA-bortezomib-dexamethasone). Costs included drug acquisition, preparation materials, personnel time, and productivity losses. Probabilistic sensitivity analysis (10 000 Monte Carlo simulations) assessed robustness to weight distribution uncertainty. Break-even analysis identified weight thresholds at which formulations were cost equivalent.

RESULTS:

Initial IV administration required 1104 minutes versus 22 minutes for SC; subsequent IV administrations required 392 minutes. Weighted average IV drug cost was €5579 versus €5652 for SC. From a societal perspective, SC generated savings of €1125 to €11 899 across all scenarios. Probabilistic analysis showed 100% probability of SC cost saving (mean €5839; 95% CI €2204-€14 317), with weight distribution uncertainty contributing only 2% of total cost variability. Break-even analysis showed IV was marginally cheaper only in patients < 68.75 kg (42.9% of cohort). From the healthcare provider perspective, SC generated higher net revenues (€308 versus €175 per administration); payer costs remained neutral (€315 per administration regardless of route).

CONCLUSIONS:

SC DARA provides robust economic advantages across all regimens, patient scenarios, and time horizons. Despite marginal cost advantages for IV in less weight patients, the comprehensive clinical and operational benefits strongly support SC as the preferred administration route.

01 Jan 2027·BIOCHIMICA ET BIOPHYSICA ACTA-MOLECULAR CELL RESEARCH

Upamostat potentiates bortezomib cytotoxicity and delays proteasome recovery in bortezomib-resistant malignant lymphoma cells through modulation of the DDI2/NRF1 axis

Article

Author: Endo, Satoshi ; Takaya, Daisuke ; Maruyama, Sota ; Kudo, Yudai ; Honma, Teruki ; Saka, Tomofumi ; Hayashi, Riri ; Yamada, Goki ; Tsujita, Tadayuki ; Yoshino, Yuta ; Ota, Atsumi ; Fukuzawa, Kaori ; Kawano, Shinya ; Ikari, Akira

Proteasome inhibitors such as bortezomib (BTZ) are potent against hematological malignancies, but acquired resistance remains a major obstacle to durable clinical responses. DNA damage-inducible 1 homolog 2 (DDI2)-mediated processing of nuclear factor erythroid 2-related factor 1 (NRF1) contributes to adaptive proteasome restoration after inhibition, and nelfinavir (NFV) is the best-characterized small-molecule inhibitor of DDI2. Since previous studies have focused primarily on aspartic protease inhibitors, and several serine protease inhibitors share structural similarities with NFV, we screened selected serine protease inhibitors to modulate the DDI2/NRF1 axis. Among them, Upamostat (UMS), a clinically tested urokinase-type plasminogen activator inhibitor, altered BTZ-induced NRF1 processing, as reflected by a reduced CF/UF ratio, in U937 cells, whereas another urokinase inhibitor, UK-371804, had no such effect, suggesting that this activity was not a general consequence of urokinase inhibition. TSA showed that UMS decreased the thermal stability of DDI2, supporting a direct interaction, and docking analysis suggested its accommodation within the retroviral protease-like domain of DDI2. In BTZ-resistant U937 (BTZ-R) cells, basal NRF1 mRNA expression and proteasome activity were elevated. UMS enhanced BTZ-induced reactive oxygen species generation, caspase activation, Annexin V positivity, and loss of cell viability, with stronger synergistic effects in BTZ-R cells than in parental cells. Although UMS did not suppress the early induction of NRF1 or proteasome-subunit transcripts, it significantly delayed recovery of chymotrypsin-like and caspase-like proteasome activities after BTZ washout. These findings identify UMS as a candidate DDI2/NRF1-axis modulator that potentiates BTZ-induced cytotoxicity and delays functional proteasome recovery in BTZ-resistant malignant lymphoma cells.

666

News (Medical) associated with Bortezomib

23 Oct 2026

·www.biospace.com

European Commission approves Johnson & Johnson’s TECVAYLI®▼ (teclistamab) monotherapy for relapsed/refractory multiple myeloma, expanding treatment options from first relapse

Approval is based on Phase 3 results demonstrating significant progression-free and overall survival benefits, with teclistamab reducing risk of disease progression or death by 71% and risk of death by 40%, compared with the standard of care 1 Further expands treatment options for relapsed/refractory multiple myeloma, making teclistamab available in the second line setting through both combination and monotherapy approaches 1, 2 BEERSE, BELGIUM, Oct. 23, 2026 (GLOBE NEWSWIRE) -- Johnson & Johnson, a worldwide leader in multiple myeloma, today announced that the European Commission (EC) has approved an indication extension of TECVAYLI ® (teclistamab) for the treatment of adult patients with relapsed/refractory multiple myeloma (RRMM) who have received at least one prior therapy. Building on the recent EC approval of teclistamab plus daratumumab , this indication extension introduces teclistamab monotherapy as an additional second-line treatment option for patients living with RRMM and reinforces the wider potential of teclistamab across both monotherapy and combination approaches for patients at first relapse. 1, 2 Building momentum for teclistamab-based regimens at first relapse Many patients with multiple myeloma relapse after first-line therapy, and treatment options are increasingly limited once the disease becomes refractory to established treatment classes. 3,4 Despite recent advances, there remains a critical need for additional effective immunotherapy options at first relapse, where treatment decisions can have a meaningful impact on long-term outcomes. 3,4 Expert and company perspectives on expanding treatment options with teclistamab “Patients with relapsed or refractory multiple myeloma often experience shorter remissions and diminishing responses with each subsequent line of therapy, making effective treatment at first relapse increasingly important,” said Cyrille Touzeau, M.D., Ph.D., Professor, University Hospital of Nantes.* “The approval of teclistamab monotherapy gives physicians an additional immunotherapy option in the second-line setting, supported by significant improvements in both progression-free and overall survival. With nearly two-thirds of patients achieving a complete response or better, the results seen with teclistamab are encouraging and demonstrate the depth of response achieved in the study.” “Building on the recent approval of teclistamab plus daratumumab, this European Commission further reinforces the strength of bispecific-based immunotherapy approaches as early as second line,” said Ester in ’t Groen, EMEA Therapeutic Area Head, Haematology, Johnson & Johnson. “Together, the MajesTEC-3 and MajesTEC-9 studies support the potential of teclistamab-based therapies to advance the treatment paradigm and improve outcomes for patients earlier in their disease journey.” “Today's approval marks another important step in our ambition to bring innovative immunotherapies earlier in the treatment journey for patients with multiple myeloma,” said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Area Head, Oncology, Johnson & Johnson. “With positive Phase 3 results from both MajesTEC-3 and MajesTEC-9, we continue to build evidence for teclistamab-based regimens across a broad second-line patient population. Together, these studies highlight the potential of teclistamab to become a foundational option at first relapse, while reinforcing our ambition to improve long-term outcomes for patients.” Phase 3 monotherapy data demonstrated significant survival benefits compared with standard of care, supporting the use of teclistamab in second-line RRMM The updated label will replace the current monotherapy indication and posology, and introduce a simplified dosing schedule with monthly dosing frequency from month 7 onwards. Eligible patients may also transition to monthly dosing as early as month 3, further optimising the dosing schedule and potentially reducing the treatment burden for patients. The EC approval is supported by data from the Phase 3 MajesTEC-9 study ( NCT05572515 ), evaluating the efficacy and safety of teclistamab, a bispecific T-cell engager, as a monotherapy versus pomalidomide, bortezomib and dexamethasone (PVd) or carfilzomib and dexamethasone (Kd) in patients with RRMM who have received one to three prior lines of therapy, including an anti-CD38 monoclonal antibody and lenalidomide. 5 Significant improvements were observed in both progression-free survival (PFS) and overall survival (OS). 1 Treatment with teclistamab demonstrated a 71% reduction in the risk of disease progression or death (hazard ratio [HR], 0.29; 95% confidence interval [CI], 0.23-0.38; p <0.001) and a 40% reduction in the risk of death (HR, 0.60; 95% CI, 0.43-0.83; p = 0.002) compared with the standard of care. 1 Teclistamab’s 18-month PFS rate was 69.8% versus 26.9% for the standard of care, and the 18-month OS rate was 79.2% with teclistamab versus 68.6% for the standard of care. 1 Additionally, all key secondary endpoints showed significant improvement with teclistamab versus standard of care, including nearly two-thirds of patients achieving a complete response or better (≥CR; 65.9% vs. 16.8%; p <0.001). 1 Safety pro with that established in prior studies The safety pro teclistamab in the study was consistent with its known safety profile. 1, 6 The median duration of treatment on teclistamab was almost two times longer than standard of care (13.1 months vs. 7.0 months), with similar rates of adverse events (AEs) observed between teclistamab and standard of care (99.7% vs. 97.9%). 1 Grade 3/4 AEs occurred in 84.9% of teclistamab recipients versus 76.3% of PVd or Kd recipients, while Grade 5 AEs occurred in 6.5% versus 3.5%, respectively. 1 Infections were more frequent with teclistamab than with standard of care (Grade 3/4, 41.6% vs. 29.0%), and rates of Grade 3 or higher infections decreased over time. 1 About the MajesTEC-9 study MajesTEC-9 ( NCT05572515 ) is an ongoing, randomised Phase 3 study comparing teclistamab monotherapy with pomalidomide, bortezomib and dexamethasone (PVd) or carfilzomib and dexamethasone (Kd) in patients with relapsed/refractory multiple myeloma (RRMM) who have received 1–3 prior lines including lenalidomide and an anti-CD38 monoclonal antibody. 5 The primary endpoint is progression-free survival (PFS); secondary endpoints include complete response or better (≥CR), duration of response (DoR), overall survival (OS), safety and patient-reported outcomes. 5 About Teclistamab Teclistamab received European Commission (EC) approval in August 2022 for the treatment of patients with RRMM who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody, and have demonstrated disease progression on the last therapy. 7 In August 2026, the EC also approved a Type II variation application for teclistamab in combination with daratumumab as early as second line for RRMM. 2 Teclistamab is an off-the-shelf (or ready-to-use) bispecific antibody. Teclistamab, a subcutaneous injection, redirects T-cells through two cellular targets (BCMA and CD3) to activate the body’s immune system to fight cancer. 6,8 Teclistamab is currently being evaluated in several combination studies. 9,10,11,12 To date, more than 30,700 patients have been treated worldwide with teclistamab. 13 For a full list of adverse events and information on dosage and administration, contraindications and other precautions when using teclistamab, please refer to the Summary of Product Characteristics at: . ▼ In line with EMA regulations for new medicines and those given conditional approval, teclistamab is subject to additional monitoring. 6 About Multiple Myeloma  Multiple myeloma is a complex blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow. 14,15 In multiple myeloma, these malignant plasma cells continue to proliferate, accumulating in the body and crowding out normal blood cells, as well as often causing bone destruction and other serious complications. 16,17 In the European Union, it is estimated that more than 35,000 people were diagnosed with multiple myeloma in 2024, and more than 21,900 patients died. 18 Patients living with multiple myeloma experience relapses which become more frequent with each line of therapy, while remissions become progressively shorter. 19 Whilst some patients with multiple myeloma initially have no symptoms, others can have common signs and symptoms of the disease, which can include bone fracture or pain, low red blood cell counts, fatigue, high calcium levels, infections, or kidney damage. 20 About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at . Follow us at . Cautions Concerning Forward-Looking Statements This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of teclistamab and daratumumab. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialise, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; competition, including technological advances, new products and patents attained by competitors; challenges to patents; changes in behaviour and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s most recent Annual Report on Form 10-K, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at , , or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments. Key Search Terms MajesTEC-9 Phase 3 clinical trial TECVAYLI Teclistamab Relapsed and or refractory multiple myeloma (RRMM) Early relapse multiple myeloma Second-line multiple myeloma treatment First relapse therapy for multiple myeloma Treatment resistance in multiple myeloma Progression-free survival (PFS) in multiple myeloma Overall survival (OS) in multiple myeloma Multiple myeloma Bispecific antibody therapy CD38-targeted therapy BCMA-targeted bispecific therapy EMEA haematology pipeline Multiple myeloma innovation Multiple myeloma treatment *Cyrille Touzeau, M.D., Ph.D., Professor, University Hospital of Nantes, has provided consulting, advisory, and speaking services to Johnson & Johnson; he has not been paid for any media work. CP-606702 October 2026 END References: 1 Touzeau C, et al. Teclistamab monotherapy in multiple myeloma with 1–3 prior lines of therapy. N Engl J Med. 2026;395(5):440-453. 2 Johnson & Johnson.com. European Commission approves Johnson & Johnson’s TECVAYLI ® ▼ (teclistamab) plus daratumumab for relapsed/refractory multiple myeloma, offering a potential new standard of care. Available at: European Commission approves Johnson & Johnson’s TECVAYLI®▼ (teclistamab) plus daratumumab for relapsed/refractory multiple myeloma, offering a potential new standard of care . Last accessed: October 2026. 3 Johnson & Johnson.com. TECVAYLI® monotherapy demonstrates superior progression-free and overall survival versus standard of care as early as first relapse in patients with multiple myeloma predominantly refractory to anti-CD38 therapy and lenalidomide. Available at: . Last accessed: October 2026. 4 Ramasamy K, et al. Real-World Treatment Patterns and Clinical Outcomes in Patients With Multiple Myeloma Previously Treated With Lenalidomide and an Anti-CD38 Monoclonal Antibody. Clin Lymphoma Myeloma Leuk. 2025 May;25(5):337-348.e2. 5 ClinicalTrials.gov. A Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma (MajesTEC-9). Available at: . Last accessed: October 2026. 6 European Medicines Agency. TECVAYLI Summary of Product Characteristics. Available at: . Last accessed: October 2026. 7 Johnson & Johnson.com. Janssen Marks First Approval Worldwide for TECVAYLI®▼ (teclistamab) with EC Authorisation of First-in-Class Bispecific Antibody for the Treatment of Patients with Multiple Myeloma. Available at: . Last accessed: October 2026. 8 Moreau P, et al. Teclistamab in Relapsed or Refractory Multiple Myeloma. N Engl J Med. 2022;387(6):494-505. 9 ClinicalTrials.gov. A Study of Teclistamab With Other Anticancer Therapies in Participants With Multiple Myeloma (MajesTEC-2). Available at: . Last accessed: October 2026. 1 0 ClinicalTrials.gov. A Study of the Combination of Talquetamab and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma. Available at: . Last accessed: October 2026. 11 ClinicalTrials.gov. A Study of Subcutaneous Daratumumab Regimens in Combination With Bispecific T Cell Redirection Antibodies for the Treatment of Participants With Multiple Myeloma. Available at: . Last accessed: October 2026. 1 2 ClinicalTrials.gov. A Study of Teclistamab in Combination With Daratumumab Subcutaneously (SC) (Tec-Dara) Versus Daratumumab SC, Pomalidomide, and Dexamethasone (DPd) or Daratumumab SC, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma (MajesTEC-3). Available at: . Last accessed: October 2026. 1 3 J&J Data on File. Number of Patients Treated with TECVAYLI Worldwide as of July 2026. 1 4 Abdi J, et al. Drug Resistance in Multiple Myeloma: Latest Findings on Molecular Mechanisms. Oncotarget. 2013;4(12):2186-2207. 1 5 Myeloma UK. What is myeloma? Available at: . Last accessed: October 2026. 1 6 Lungu O, et al. Mechanistic insights into bone destruction in multiple myeloma: cellular and molecular perspectives. Journal of Bone Oncology. 2025;51:100668. 1 7 Mayo Clinic. Multiple Myeloma. Available at: . Last accessed: October 2026. 1 8 ECIS - European Cancer Information System. Estimates of Cancer Incidence and Mortality in 2024, by Country. Multiple Myeloma. Available at: . Last accessed: October 2026. 1 9 Bhatt P, et al. Relapsed/Refractory Multiple Myeloma: A Review of Available Therapies and Clinical Scenarios Encountered in Myeloma Relapse. Curr Oncol. 2023;30(2):2322-2347. 2 0 American Cancer Society. Multiple Myeloma: Early Detection, Diagnosis and Staging. Available at: . Last accessed: October 2026. CONTACT: Media contact: Jenni Mildon jmildon@its.jnj.com +44 7920 418 552 Investor contact: Jess Margevich investor-relations@its.jnj.com

Phase 3Clinical ResultImmunotherapyDrug Approval

19 Oct 2026

·www.biospace.com

Enable Injections Announces Approval in Japan for CirCLIQ® Injector based on enFuse® On-Body Delivery System

Sanofi's CirCLIQ® Injector, developed using enFuse technology, has been approved to administer Sarclisa subcutaneous formulation, in combination with approved standard-of-care regimens, for patients with multiple myeloma CINCINNATI, Oct. 19, 2026 (GLOBE NEWSWIRE) -- Enable Injections, Inc. (“Enable”), a leader in wearable drug delivery technologies, today announced the first regulatory approval of its enFuse ® On-Body Delivery System technology by Japan’s Ministry of Health, Labour and Welfare through Sanofi's CirCLIQ ® Injector for the administration of Sarclisa (isatuximab) subcutaneous (SC) formulation, in combination with approved standard-of-care regimens, for the treatment of multiple myeloma (MM). The approved indications for Sarclisa SC in Japan include in combination with pomalidomide and dexamethasone (Pd), or with carfilzomib for the treatment of relapsed or refractory MM (R/R MM) and in combination with bortezomib, lenalidomide, and dexamethasone (VRd), for the treatment of adult patients with newly diagnosed multiple myeloma (NDMM). The approval marks Enable's first commercial product approval in Japan and the first anticancer treatment to be administered via an on-body injector (OBI) in the country. It further expands the global reach of Enable's enFuse technology through the CirCLIQ Injector following recent approvals in the United States and Europe . “This approval is another important milestone in our mission to expand access to novel drug delivery solutions around the world,” said Michael D. Hooven, Chairman and CEO of Enable Injections. “We're proud to partner with Sanofi to bring our enFuse technology to patients in Japan and to support an innovative treatment option for people living with multiple myeloma. As the adoption of subcutaneous delivery continues to grow globally, we're excited to help our pharmaceutical partners bring more therapies to patients.” The CirCLIQ Injector, developed using Enable's enFuse technology, is designed to subcutaneously deliver Sarclisa with the push of a button. The OBI uses a hidden, retractable needle that is shorter and thinner compared to the needles commonly used for large-volume subcutaneous injections. The Japan approval of Sarclisa SC in June 2026 was supported by results from the IRAKLIA phase 3 study in R/R MM, which demonstrated the non-inferiority of the SC formulation compared to intravenous, as well as supportive studies. The studies evaluated Sarclisa SC administered through both manual SC administration and an OBI based on enFuse technology. Enable partners with leading biopharmaceutical companies to deliver medication using its enFuse System, enabling the subcutaneous delivery of large-volume biologic therapies across a growing range of therapeutic areas, including oncology, hematology, immunology, and rare disease. About Enable Injections Cincinnati-based Enable Injections is a global healthcare innovation company committed to improving the patient treatment experience through the development and manufacturing of the enFuse ® On-Body Delivery System. An innovative wearable technology, the enFuse System is designed to deliver large volumes of pharmaceutical and biologic therapeutics via subcutaneous administration, with the aim of improving convenience, supporting superior outcomes, and advancing healthcare system economics. Enable is currently working with a number of pharmaceutical partners to conduct clinical trials and plan for joint commercial launch of their therapies in combination with the enFuse technology. For more information, visit . About Sarclisa Sarclisa (isatuximab-irfc) has been approved in almost 60 countries across four indications for certain patients with NDMM and R/R MM. Sarclisa-based regimens have been prescribed to treat more than 70,000 patients worldwide. Sarclisa SC (Sarclisa Escena in the US), the subcutaneous formulation of Sarclisa, is approved in the US, in the EU, Japan and in the UK, in combination with approved standard-of-care regimens for the treatment of patients with MM across all currently approved indications for Sarclisa IV in these countries. It is the first anticancer treatment to be administered through an OBI, and the only anti-CD38 monoclonal antibody available in MM to offer the flexibility of both SC OBI and manual injection administration. At Sanofi, we are building on a long-standing commitment to oncology as we continue to chase the miracles of science to improve the lives of those living with cancer. We are committed to transforming cancer care by developing innovative, first and best-in-class immunological and targeted therapies for rare and difficult-to-treat cancers with high unmet need. For more information on Sarclisa clinical studies, please visit About Sanofi Sanofi is an R&D driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Our team is guided by one purpose: we chase the miracles of science to improve people’s lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media Contact: Jenn Beeson jbeeson@enableinjections.com

Drug ApprovalPhase 3Clinical ResultImmunotherapy

16 Oct 2026

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CHMP recommends approval of Johnson & Johnson’s TALVEY®▼ (talquetamab) plus daratumumab in earlier line treatment of relapsed/refractory multiple myeloma

If approved, TALVEY ® plus daratumumab will be the only GPRC5D-targeting bispecific antibody combination therapy for relapsed or refractory multiple myeloma as early as second line CHMP recommendation based on Phase 3 results where talquetamab and daratumumab, with or without pomalidomide, showed progression-free survival of up to 81% and overall survival of up to 89% at 24 months 1 BEERSE, BELGIUM, Oct. 16, 2026 (GLOBE NEWSWIRE) -- Johnson & Johnson, a worldwide leader in multiple myeloma, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommends the approval of an indication extension of TALVEY ® (talquetamab). The recommendation is for talquetamab plus daratumumab with or without pomalidomide for the treatment of adults with relapsed or refractory multiple myeloma (RRMM), who have received at least one prior therapy. Combination of talquetamab plus daratumumab offers a novel target approach to RRMM treatment, with potential to spare healthy immune cells Talquetamab targets a protein called GPRC5D, which is found on multiple myeloma cells (as well as some healthy cells in the body). 2 GPRC5D expression is independent of other targets, including BCMA, and is absent or expressed at low levels on normal B-cells . 2 Talquetamab works by targeting myeloma cells while largely sparing healthy B-cells. 2 With daratumumab priming the immune system for enhanced talquetamab activity, the combination benefits from complementary mechanisms of action, reinforcing the potential effectiveness of this approach in multiple myeloma. 2 , 3 , 4 Expert and company perspectives support talquetamab use earlier in the treatment pathway “MonumenTAL-3 demonstrated significant improvements in progression-free survival, overall survival, response rates and depth of response with the combination of talquetamab and daratumumab,” said Ester in ’t Groen, EMEA Therapeutic Area Head, Haematology, Johnson & Johnson. “For patients facing their first relapse, this combination has the potential to provide deep responses and keep their disease under control for longer at a critical point in their treatment journey. This CHMP recommendation reflects the continued evolution of the talquetamab programme in multiple myeloma, and further strengthens the potential of talquetamab-based therapies as early as second line, building on our commitment to generate data that can help inform treatment choices based on patients’ prior therapies and disease characteristics.” “At Johnson & Johnson, our strategy is grounded in pursuing differentiated immunotherapy approaches earlier in the disease course to address diverse patient characteristics and the evolving complexity of multiple myeloma,” said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Area Head, Oncology, Johnson & Johnson. “This off-the-shelf, immunotherapy-based combination leverages the power of our portfolio by bringing together talquetamab with the well-established therapy of daratumumab. By simultaneously targeting GPRC5D and CD38, our goal is to deliver deeper and longer lasting responses for patients.” Talquetamab combination has delivered significant clinical benefits from second line The MonumenTAL-3 study evaluated talquetamab plus daratumumab (Tal-D) or Tal-D and pomalidomide (Tal-DP) compared to daratumumab plus pomalidomide and dexamethasone (DPd) in patients with RRMM who have received at least one prior line of therapy. 5 At a median follow-up of two years (24.6 months), results showed significant improvement in progression-free survival (PFS) for Tal-DP (hazard ratio [HR], 0.28; 95% confidence interval [CI], 0.20-0.40; p <0.0001) and Tal-D (HR, 0.33; 95% CI, 0.24-0.46; p <0.0001). 2 At 24 months, Tal-DP showed a PFS rate of 81.3% and Tal-D showed a PFS rate of 77.6%. 2 All participants (N=864) were previously exposed to lenalidomide and a proteasome inhibitor and received at least one prior line of therapy. 2 Most patients enrolled were refractory to lenalidomide (85.1%) and their last line of therapy (93.4%), and some were exposed to an anti-CD38 antibody (11.8%). 1 Statistically significant improvements compared to DPd were observed across key secondary endpoints of overall response rate (ORR), complete response or better (≥CR) and minimal residual disease (MRD)-negative ≥CR (10 -5 , next-generation sequencing [NGS]) for Tal-DP and Tal-D. 2 ORRs (88.2%, 88.5%, 77.6%), ≥CR rates (71.1%, 68.9%, 34.5%) and MRD-negative ≥CR rates (52.3%, 46.3%, 15.9%) were significantly higher for Tal-DP and Tal-D vs DPd, respectively, after two years median follow-up. 2 Clinically meaningful improvement in overall survival (OS) was shown with Tal-DP (HR, 0.47; 95% CI, 0.30-0.73; p =0.0006) and Tal-D (HR, 0.51; 95% CI, 0.33-0.78; p =0.0015) vs DPd. 2 At 24 months, Tal-DP delivered an OS rate of 89.2% and Tal-D delivered an OS rate of 87.9%. 2 Safety profiles consistent with the known safety profiles of each monotherapy The overall safety profiles for the talquetamab plus daratumumab treatment arms were consistent with the known safety profiles of each monotherapy. 2 Overall, rates of Grade 3/4 treatment-emergent adverse events (TEAEs) were comparable across treatment arms (94.9% with Tal-DP, 74.8% with Tal-D and 91.5% with DPd). 1 Infections occurred at rates of 87.3% (Tal-DP), 84.3% (Tal-D) and 83.0% (DPd). 2 Tal-D had the lowest rate of Grade 3/4 infections (29.2%), followed by Tal-DP (37.7%) and DPd (42.2%). 2 There were some instances of Grade 5 adverse events (AEs) across the entire population of the study; the Tal-DP arm saw the fewest (1.8%), followed by Tal-D (4.0%) and DPd (4.6%), with approximately 0.7% (Tal-DP), 1.5% (Tal-D) and 1.8% (DPd) due to infections. 1 Treatment discontinuations due to AEs occurred in 10.5% of Tal-DP, 8.0% of Tal-D and 6.7% of DPd patients. 2 At data cutoff; 70.3% (Tal-DP), 69.7% (Tal-D) and 47.3% (DPd) of patients remained on study treatment. 2 About the MonumentTAL-3 Study The MonumenTAL-3 ( NCT05455320 ) study is an ongoing Phase 3 study of talquetamab in combination with daratumumab subcutaneous (SC) with or without pomalidomide compared to daratumumab SC combined with pomalidomide and dexamethasone in patients with relapsed or refractory multiple myeloma (RRMM) who have received at least one prior line of therapy. 5 The primary endpoint is progression-free survival (PFS) and secondary endpoints include overall response rate (ORR), complete response or better (≥CR), minimal residual disease (MRD)-negative ≥CR (10 -5 by next-generation sequencing), overall survival (OS) and safety. 5 The MonumenTAL-3 study is a part of the MonumenTAL clinical programme, which includes exploring the potential of talquetamab as a combination regimen. 5 About Talquetamab Talquetamab received conditional marketing authorisation (CMA) from the European Commission (EC) in August 2023, as monotherapy for the treatment of adult patients with RRMM who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy. 6 The U.S. FDA also granted talquetamab approval in August 2023, for the treatment of adult patients with RRMM who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody. 7 Talquetamab is a bispecific T-cell engaging antibody that binds to CD3 on T-cells, and GPRC5D, a novel target which is highly expressed on the surface of multiple myeloma cells, with minimal to no expression detected on B-cells or B-cell precursors. 6 To date, more than 11,000 patients have been treated with talquetamab worldwide. 8 For a full list of adverse events and information on dosage and administration, contraindications and other precautions when using talquetamab, please refer to the Summary of Product Characteristics . In line with the European Medicine Agency’s regulations for new medicines and those given conditional approval, talquetamab is subject to additional monitoring. ▼ In line with EMA regulations for new medicines and those given conditional approval, talquetamab is subject to additional monitoring. 6 About Daratumumab and Daratumumab SC Johnson & Johnson is committed to exploring the potential of daratumumab for patients with multiple myeloma across the spectrum of the disease. In August 2012 , Janssen Biotech, Inc., a Johnson & Johnson company, and Genmab A/S entered a worldwide agreement, which granted Johnson & Johnson an exclusive licence to develop, manufacture and commercialise daratumumab. Since launch, daratumumab has become a foundational therapy in the treatment of multiple myeloma, having been used in the treatment of more than 830,000 patients worldwide. 9 Daratumumab was the first CD38-directed antibody approved to be given subcutaneously to treat patients with multiple myeloma. 10 , 11 Daratumumab SC was also the first oncology injectable approved for administration by patients living with multiple myeloma or their caregivers from the fifth dose, if determined to be appropriate by their healthcare professional and following proper training. 11 , 12 Daratumumab SC is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme's ENHANZE ® drug delivery technology. 11 CD38 is a surface protein that is present in high numbers on multiple myeloma cells, regardless of the stage of disease. 11 , 13 Daratumumab binds to CD38 and inhibits tumour cell growth causing myeloma cell death. 11 Daratumumab may also have an effect on normal cells. 11 Data across ten Phase 3 clinical trials, in both the frontline and relapsed settings across all newly diagnosed multiple myeloma patients, have shown that daratumumab-based regimens resulted in significant improvement in progression-free survival and/or overall survival. 14 , 15 , 16 , 17 , 18 , 19 , 20 , 21 , 22 , 23 For further information on daratumumab, please see the Summary of Product Characteristics at: . About Multiple Myeloma Multiple myeloma is a complex blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow. 24 , 25 In multiple myeloma, these malignant plasma cells continue to proliferate, accumulating in the body and crowding out normal blood cells, as well as often causing bone destruction and other serious complications. 26 , 27 In the European Union, it is estimated that more than 35,000 people were diagnosed with multiple myeloma in 2024, and more than 21,900 patients died. 28 Patients living with multiple myeloma experience relapses which become more frequent with each line of therapy, while remissions become progressively shorter. 29 , 30 , 31 Whilst some patients with multiple myeloma initially have no symptoms, others can have common signs and symptoms of the disease, which can include bone fracture or pain, low red blood cell counts, fatigue, high calcium levels, infections, or kidney damage. 32 About Johnson & Johnson’s Multiple Myeloma Portfolio Johnson & Johnson is a global leader in multiple myeloma therapies, with a broad and differentiated portfolio designed to address the complexity and heterogeneity of the disease. Our portfolio spans multiple mechanisms of action, targets and treatment modalities, including CD38-directed therapies, BCMA- and GPRC5D-targeting bispecific antibodies, and cellular therapies. Over the past decade, Johnson & Johnson therapies have helped extend survival for patients with multiple myeloma. With the right medicines, used as early as possible, combined and sequenced for the best results, Johnson & Johnson is expanding treatment options to match the right therapy to the right patient at the right stage of disease and drive deeper and more durable responses. Through ongoing research and a robust clinical programme, Johnson & Johnson is committed to transforming multiple myeloma into a more manageable condition that is no longer treated to progression but has the potential to, ultimately, be cured. About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at . Follow us at . Cautions Concerning Forward-Looking Statements This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of talquetamab and daratumumab. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialise, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; competition, including technological advances, new products and patents attained by competitors; challenges to patents; changes in behaviour and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s most recent Annual Report on Form 10-K, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at , , or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments. Key Search Terms MonumenTAL-3 clinical trial TALVEY Talquetamab Talquetamab plus daratumumab Relapsed and or refractory multiple myeloma (RRMM) Early relapse multiple myeloma Second-line multiple myeloma treatment First relapse therapy for multiple myeloma Treatment resistance in multiple myeloma Progression-free survival (PFS) in multiple myeloma Overall survival (OS) in multiple myeloma Multiple myeloma Bispecific antibody therapy BCMA-targeted bispecific therapy EMEA haematology pipeline Multiple myeloma innovation Multiple myeloma treatment END References: 1 Mina R, et al. MonumenTAL-3 Investigators. Talquetamab–Daratumumab in Relapsed or Refractory Myeloma. New England Journal of Medicine. 2026;395(7):671-683. 2 Voorhees P, et al. Phase 3 randomized study of talquetamab (TAL) plus daratumumab (DARA) ± pomalidomide (POM) vs DARA plus DOM ad dexamethasone (DPD) in relapsed/refractory multiple myeloma (RRMM): MonumenTAL-3. Presented at: 2026 European Hematology Association Congress; June 13, 2026; Stockholm. 3 Chari A, et al. Talquetamab plus daratumumab for the treatment of relapsed or refractory multiple myeloma in the TRIMM-2 study. Blood. 2025;146(24). 4 Verkleij C, et al. Preclinical activity and determinants of response of the GPRC5DxCD3 bispecific antibody talquetamab in multiple myeloma. Blood. 2021;5(8):2195-2215. 5 ClinicalTrials.gov. MonumenTAL-3: Study of talquetamab in combination with daratumumab ± pomalidomide versus daratumumab + pomalidomide + dexamethasone in relapsed or refractory multiple myeloma (NCT05455320). Available at: . Last accessed: October 2026. 6 European Medicines Agency. TALVEY Summary of Product Characteristics. Available at: . Last accessed: October 2026. 7 FDA. FDA grants accelerated approval to talquetamab-tgvs for relapsed or refractory multiple myeloma. Available at: . Last accessed: October 2026. 8 J&J Data on File. Number of Patients Treated with TALVEY ® worldwide as of March 2026. 9 J&J Data on File. Number of Patients Treated with DARZALEX ® Worldwide as of August 2026. 10 Janssen EMEA. European Commission Grants Marketing Authorisation for DARZALEX ® (Daratumumab) Subcutaneous Formulation for All Currently Approved Daratumumab Intravenous Formulation Indications. Available at: . Last accessed: October 2026. 11 European Medicines Agency. DARZALEX Summary of Product Characteristics. Available at: . Last accessed: October 2026. 12 J&J Data on File. DARZALEX® is the first oncology injectable approved for self-administration by patients or caregivers as of March 2026. 13 Fedele G, et al. CD38 ligation in peripheral blood mononuclear cells of myeloma patients induces release of protumorigenic IL-6 and impaired secretion of IFNy cytokines and proliferation. Mediators Inflamm. 2013;564687. 14 Moreau P, et al. Bortezomib, Thalidomide, and Dexamethasone With or Without Daratumumab Before and After Autologous Stem-Cell Transplantation for Newly Diagnosed Multiple Myeloma (CASSIOPEIA): A Randomised, Open-label, Phase 3 Study. Lancet. 2019;394(10192):29-38. 15 Facon T, et al. MAIA Trial Investigators. Daratumumab Plus Lenalidomide and Dexamethasone for Untreated Myeloma. New England Journal of Medicine. 2019;380(22):2104-2115. 16 Mateos MV, et al. Overall Survival with Daratumumab, Bortezomib, Melphalan, and Prednisone in Newly Diagnosed Multiple Myeloma (ALCYONE): A Randomised, Open-label, Phase 3 Trial. The Lancet. 2020;395(10218):132-141. 17 Dimopoulos MA, et al. APOLLO Trial Investigators. Daratumumab Plus Pomalidomide and Dexamethasone Versus Pomalidomide and Dexamethasone Alone in Previously Treated Multiple Myeloma (APOLLO): An Open-label, Randomised, Phase 3 Trial. Lancet Oncol. 2021;22(6):801-812. 18 Palladini G, et al. Daratumumab Plus CyBorD for Patients with Newly Diagnosed AL Amyloidosis: Safety Run-in Results of ANDROMEDA. Blood. 2020;2;136(1):71-80. 19 Chari A, et al. Daratumumab Plus Pomalidomide and Dexamethasone in Relapsed and/or Refractory Multiple Myeloma. Blood. 2017;130(8):974-981. 20 Bahlis NJ, et al. Daratumumab Plus Lenalidomide and Dexamethasone in Relapsed/Refractory Multiple Myeloma: Extended Follow-up of POLLUX, A Randomized, Open-label, Phase 3 study. Leukemia. 2020;34(7):1875-1884. 21 Mateos MV, et al. Daratumumab, Bortezomib, and Dexamethasone Versus Bortezomib and Dexamethasone in Patients with Previously Treated Multiple Myeloma: Three-Year Follow-up of CASTOR. Clin Lymphoma Myeloma Leuk. 2020;20(8):509-518. 22 Usmani S Z, et al. Daratumumab + Bortezomib/Lenalidomide/Dexamethasone in Patients with Transplant-Ineligible or Transplant-Deferred Newly Diagnosed Multiple Myeloma: Results of the Phase 3 CEPHEUS Study. Oral Presentation. 21 st International Myeloma Society (IMS) Annual Meeting. September 25 – 28, 2024. 23 Sonneveld P, et al. Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone for Multiple Myeloma. New England Journal of Medicine. 2024; 390(4):301-313. 24 Abdi J, et al. Drug Resistance in Multiple Myeloma: Latest Findings on Molecular Mechanisms. Oncotarget. 2013;4(12):2186-2207. 25 Myeloma UK. What is myeloma? Available at: . Last accessed: October 2026. 26 Lungu O, et al. Mechanistic insights into bone destruction in multiple myeloma: cellular and molecular perspectives. Journal of Bone Oncology. 2025;51:100668. 27 Mayo Clinic. Multiple Myeloma. Available at: . Last accessed: October 2026. 28 ECIS - European Cancer Information System. Estimates of Cancer Incidence and Mortality in 2024, by Country. Multiple Myeloma. Available at: . Last accessed: October 2026. 29 Bhatt P, et al. Relapsed/Refractory Multiple Myeloma: A Review of Available Therapies and Clinical Scenarios Encountered in Myeloma Relapse. Curr Oncol. 2023;30(2):2322-2347. 30 Hernández-Rivas JÁ, et al. The Changing Landscape of Relapsed and/or Refractory Multiple Myeloma (MM): Fundamentals and Controversies. Biomark Res. 2022;10(1):1-23. 31 McCurdy A, et al. Redefining attrition in multiple myeloma (MM): a Canadian myeloma research group (CMRG) analysis. Blood Cancer Journal. 2023;13(1):111. 32 American Cancer Society. Multiple Myeloma: Early Detection, Diagnosis and Staging. Available at: . Last accessed: October 2026. CP606521 October 2026 CONTACT: Media contact: Jenni Mildon jmildon@its.jnj.com +44 7920 418 552 Investor contact: Jess Margevich investor-relations@its.jnj.com

Clinical ResultPhase 3Drug ApprovalLicense out/inImmunotherapy

100 Deals associated with Bortezomib

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KEGG	Wiki	ATC	Drug Bank
D03150	Bortezomib	L01XG01	DB00188

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Immunoglobulin Light-Chain Amyloidosis	Japan	Janssen Pharmaceutical KK	20 Oct 2006
Waldenstrom Macroglobulinemia	Japan	Janssen Pharmaceutical KK	20 Oct 2006
Mantle-Cell Lymphoma	European Union	Janssen-Cilag International NV	26 Apr 2004
Mantle-Cell Lymphoma	Iceland	Janssen-Cilag International NV	26 Apr 2004
Mantle-Cell Lymphoma	Liechtenstein	Janssen-Cilag International NV	26 Apr 2004
Mantle-Cell Lymphoma	Norway	Janssen-Cilag International NV	26 Apr 2004
Multiple Myeloma	United States	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	Italy	Janssen-Cilag Ltd.	04 Feb 2013
Diffuse large B-cell lymphoma recurrent	Phase 3	Italy	Janssen Pharmaceutica NV	04 Feb 2013
Diffuse large B-cell lymphoma refractory	Phase 3	Italy	Janssen Pharmaceutica NV	04 Feb 2013
Diffuse large B-cell lymphoma refractory	Phase 3	Italy	Janssen-Cilag Ltd.	04 Feb 2013
Plasma Cell Leukemia	Phase 3	China	Janssen Scientific Affairs LLC	13 Jan 2012
Plasma Cell Leukemia	Phase 3	Australia	Janssen Scientific Affairs LLC	13 Jan 2012
Plasma Cell Leukemia	Phase 3	South Korea	Janssen Scientific Affairs LLC	13 Jan 2012
Diffuse Large B-Cell Lymphoma	Phase 3	Switzerland	Janssen-Cilag Ltd.	01 Apr 2011
Diffuse Large B-Cell Lymphoma	Phase 3	United Kingdom	Janssen-Cilag Ltd.	01 Apr 2011
B-Cell Lymphoma	Phase 3	United States	Millennium Pharmaceuticals, Inc.	01 Mar 2006

Clinical Result

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05432414 (POM-MM-003, Pubmed \| Med)	Phase 2	-	82	Pomalidomide + Bortezomib + Dexamethasone	impjcrwobi(djkuapigek) = isvivlnmkz geoxjlwszq (zpawvywrce, 59.1 - 83.3) View more	Positive	01 Oct 2026
				Bortezomib + Dexamethasone	impjcrwobi(djkuapigek) = yytdbleesx geoxjlwszq (zpawvywrce, 7.1 - 42.2) View more
IMS2026	Not Applicable	Immunoglobulin Light-Chain Amyloidosis	35	Daratumumab+Bortezomib+Methylprednisolone	qaafaovbla(hbrcosijls) = yiwfcqthta ysinqtrpys (swnfnagofo ) View more	Positive	23 Sep 2026
IMS2026	Not Applicable	Multiple Myeloma	14	Isatuximab+Bortezomib+Lenalidomide+Dexamethasone	pagqwskooc(sqgiwhmout) = 40% (4/10) rhzwireyel (sqaxbjdcnn ) View more	Positive	23 Sep 2026
IMS2026	Not Applicable	Multiple Myeloma	114	Bortezomib-cyclophosphamide-dexamethasone (VCD)	fusjmhynzs(qgdaqymikv) = bstrkqswyh narmxkaiwm (bgivtbjejy ) View more	Positive	23 Sep 2026
				Bortezomib-lenalidomide-dexamethasone (VRD)	yqfdrlxlfp(mlkcwluepc) = mncaukxvqg zfgtuclgiu (loqcbzaaaw )
IMS2026	Not Applicable	Multiple Myeloma First line	126	Bortezomib, Thalidomide, and Dexamethasone (VTd) (Underwent Autologous Stem Cell Transplantation (ASCT))	zqplmfasth(cuyunjjcof) = omiekwwxsw tjvzcpydfm (zykljtjcnt ) View more	Positive	23 Sep 2026
				Bortezomib, Thalidomide, and Dexamethasone (VTd) (Did Not Undergo Autologous Stem Cell Transplantation (ASCT))	zqplmfasth(cuyunjjcof) = tgrkmazcit tjvzcpydfm (zykljtjcnt ) View more
IMS2026	Not Applicable	Multiple Myeloma hemoglobin level	504	Bortezomib-based therapy	ednttytmuz(rosjilvteh) = mtuqsextwc fncpdgvqmv (jjniouarlb ) View more	Positive	23 Sep 2026
NCT03829371 (REAL MM, IMS2026)	Phase 4	Multiple Myeloma	401	Bortezomib-melphalan-prednisone (VMP)	swszofhjdz(ssvadvepus) = svqyfshqlp fvefzpziyj (szphviwehr )	Positive	23 Sep 2026
				Bortezomib+melphalan+prednisone+daratumumab (DVMP)	-
BOSTON (IMS2026)	Not Applicable	Multiple Myeloma	9	Selinexor+Bortezomib+Dexamethasone	zsuafbwwta(tuhntzyniv) = Only one patient experienced >Grade 2 thrombocytopenia, which was successfully managed with a gradual dose reduction to 40 mg fxznpchall (xiuapnrzmm ) View more	Positive	23 Sep 2026
				Lenalidomide
IMS2026	Not Applicable	Multiple Myeloma	8	Bortezomib based therapy	tuycvpydlh(hvkshrflec) = xdgsfxsdxm grhckpfzlg (nqvxuqvubc ) View more	Positive	23 Sep 2026
DETERMINATION (IMS2026)	Phase 3	Multiple Myeloma Duffy null status	493	Lenalidomide+Bortezomib+Dexamethasone	fkhwmwouwk(kachrbrxsc) = xpaelcxzmg eobwqsmvgd (jzqitxnvsr )	Positive	23 Sep 2026
				Lenalidomide+Bortezomib+Dexamethasone (ASCT)	fkhwmwouwk(kachrbrxsc) = uwfhnhhocu eobwqsmvgd (jzqitxnvsr )

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