TALVEY®▼ (talquetamab) bispecific therapy approved for reimbursement for the treatment of patients with relapsed and refractory multiple myeloma
Dublin, Ireland, 6th November 2025 – Johnson & Johnson Innovative Medicine announced today that TALVEY®▼ (talquetamab) has been approved for reimbursement in Ireland as a monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma (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. The announcement follows conditional marketing authorisation (CMA) in 2023 which was supported by positive results from the Phase 1/2 MonumenTAL-1 study evaluating the safety and efficacy of talquetamab in patients with RRMM.[1]
Multiple myeloma remains an incurable blood cancer, with nearly all patients relapsing and requiring subsequent therapy.[2],[3] As the disease progresses, relapses for patients become more aggressive with each new line of therapy, and remissions become progressively shorter. Approximately, 380 people are diagnosed with multiple myeloma each year in Ireland.[4] While Irish figures show that the five-year net survival for someone diagnosed with MM has increased from 30% in the mid-1990s to 60% by 2020, the unmet need for those with RRMM remains.[5]
Talquetamab is a bispecific T-cell engaging antibody that binds to CD3, on the surface of T-cells, and G protein-coupled receptor class C group 5 member D (GPRC5D), a novel target expressed on the surface of multiple myeloma cells and hard keratinised tissues, with minimal to no expression detected on B-cells and B-cell precursors.[6] Talquetamab is approved as a weekly (QW) or biweekly (Q2W) subcutaneous (SC) injection, after an initial step-up phase.6
Dr Janusz Krawczyk, Consultant Haematologist at Galway University Hospital said: “The treatment landscape for multiple myeloma demands continuous innovation. The reimbursement of talquetamab is a positive development for people living with relapsed and refractory disease, a cohort who have gone through complex treatment and experience challenging outcomes. Talquetamab’s novel mechanism, engaging the GPRC5D target, offers a distinct therapeutic approach for advanced disease. We are encouraged by its ability to induce deep responses, even in those who have undergone extensive prior treatments, underscoring its potential to truly make a difference in this hard-to-treat blood cancer.”
Michaela Hagenhofer, General Manager, Commercial Operations at Johnson & Johnson Innovative Medicine said: “The reimbursement of talquetamab in Ireland marks a key milestone in J&J’s commitment to advancing multiple myeloma care. This innovative therapy, now accessible to Irish patients, provides clinicians additional options for advanced disease. With over two decades of research, we are committed to improving outcomes through a portfolio of immunotherapies that can be used as monotherapy or in combination at various disease stages. We are proud that talquetamab is manufactured at our biopharmaceutical facility in Ringaskiddy, Co Cork, which also supplied clinical trial stock for its development and approval.”
Patients in the Phase 1/2 MonumenTAL-1 study (0.8 mg/kg Q2W: n=145; 0.4 mg/kg QW: n=143) had received a median of five (range, 2-17) prior lines of therapy and showed meaningful overall response rates (ORR) across both doses.1 With a median follow-up of 12.7 months, 71.7 percent (95 percent Confidence Interval [CI], 63.7-78.9) of response-evaluable patients treated at the 0.8 mg/kg Q2W dose achieved a response, 60.8 percent achieved a very good partial response (VGPR) or better and 38.7 percent achieved a complete response (CR) or better.1 With a median follow-up of 18.8 months, 74.1 percent (95 percent CI, 66.1-81.1) of response-evaluable patients treated with the 0.4 mg/kg QW dose achieved a response, 59.5 percent achieved a VGPR or better and 33.6 percent achieved a CR or better.1 Responses were durable with a median duration of response not reached (95 percent CI, 13-Not Estimable [NE]) in the 0.8 mg/kg Q2W dose group and 9.5 months (95 percent CI, 6.7-13.3) in the 0.4 mg/kg QW dose group.1 An estimated 76.3 percent and 51.5 percent of patients maintained a response for at least nine months at the 0.8 mg/kg Q2W and 0.4 mg/kg QW doses, respectively.1
The MonumenTAL-1 study also included 51 patients with prior T-cell redirection therapy.1 Patients had received a median of five (3-15) prior lines of therapy, including prior exposure to a bispecific antibody (35.3 percent), CAR-T cell therapy (70.6 percent) or both (six percent).1 With a median duration of follow-up of 14.8 months, 64.7 percent of patients achieved a response, 54.9 percent achieved a VGPR or better and 35.3 percent achieved a CR or better.1 Median duration of response was 11.9 months (95 percent CI, 4.8-NE) and the 12-month overall survival rate was 62.9 percent.1
The most common adverse events (AEs) observed in the study were cytokine release syndrome (CRS; 77 percent, 1.5 percent Grade 3 or 4), dysgeusia (72 percent, all Grade 1 or 2), hypogammaglobulinaemia (67 percent, all Grade 1 or 2) and nail disorders (56 percent, all Grade 1 or 2).1 In addition, 40 percent of patients experienced weight loss, including 3.2 percent with Grade 3 or 4 weight loss.1 The most common infections were upper respiratory tract infection (29 percent, 2.1 percent Grade 3 or 4) and COVID-19 (19 percent, 2.9 percent Grade 3 or 4).1 Neurologic toxicities were reported in 29 percent of patients, including immune effector cell-associated neurotoxicity syndrome (ICANS; 10 percent, 2.3 percent Grade 3 or 4).1 Adverse reactions leading to treatment discontinuation were mainly due to ICANS (1.1 percent) and weight loss (0.9 percent).1
For further information please contact:
Fiona Peppard – T: +353 87 635 4423, E: fiona.peppard@ogilvy.com
Orla Dormer – T: +353 85 708 6877, E: odormer@its.jnj.com
About Talquetamab
Talquetamab is a bispecific T-cell engaging antibody that binds to CD3, on T-cells, and GPRC5D, a novel multiple myeloma target which is highly expressed on the surface of multiple myeloma cells and hard keratinised tissues, with minimal to no expression detected on B-cells or B-cell precursors.1 Talquetamab, which is administered by subcutaneous injection, is currently being evaluated in several monotherapy and combination studies.[7],[8],[9],[10],[11],[12],[13]
CMA is the approval of a medicine that addresses unmet medical needs of patients based on less comprehensive data than normally required, where the available data suggest that the benefits of the medicine outweigh the risks, and the applicant can provide comprehensive clinical data in the future.[14] Prior to the CHMP recommending this CMA, the EMA granted talquetamab PRIority MEdicines (PRIME) designation in January 2021 and accelerated assessment in November 2022. The U.S. FDA granted talquetamab Breakthrough Therapy Designation in June 2022. Janssen also received Orphan Drug Designation for talquetamab from the FDA in May 2021 and in July 2023, the Committee for Orphan Medicinal Products (COMP) of the EMA recommended by consensus that the orphan designation for talquetamab be maintained, on the basis of clinical data demonstrating improved and durable responses with talquetamab in patients with RRMM, who had been pretreated with the authorised medicinal products TECVAYLI®▼ (teclistamab), ABECMA®▼ (idecabtagene vicleucel) and CARVYKTI®▼ (ciltacabtagene autoleucel; cilta-cel).
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.
About the MonumenTAL-1 Study
MonumenTAL-1 (Phase 1: NCT03399799, Phase 2: NCT04634552), is a Phase 1/2 single-arm, open-label, multicohort, multicentre dose-escalation study to evaluate the safety and efficacy of talquetamab in adults with RRMM who received three or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.6,7
Phase 1 of the study (NCT03399799) was conducted in two parts: dose escalation and dose expansion.7 It evaluated safety, tolerability, pharmacokinetics and preliminary antitumour activity of talquetamab administered to adult participants with RRMM.7 Phase 2 of the study (NCT04634552) evaluated the efficacy of talquetamab in participants with RRMM at the recommended phase 2 doses (RP2Ds), established at SC 0.8 mg/kg Q2W and 0.4 mg/kg QW, respectively, as measured by ORR.8
About Multiple Myeloma
Multiple myeloma is an incurable blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.[15],[16] In multiple myeloma, these malignant plasma cells change and grow out of control.14 In Ireland, approximately 2,200 people are living with MM and around 350 people are diagnosed with it annually.15 While some patients with multiple myeloma initially have no symptoms, others can have common symptoms of the disease which can include bone fracture or pain, low red blood cell counts, tiredness, high calcium levels or kidney failure.[17]
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Learn more at https://www.jnj.com/innovativemedicine/ireland/. Follow us at www.linkedin.com/showcase/jnj-innovative-medicine-ireland/. Janssen Sciences Ireland UC, and Janssen Research & Development, LLC are Johnson & Johnson companies.
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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. 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 Janssen Pharmaceutica NV, Janssen-Cilag Limited, Janssen Research & Development, LLC or any of the other Janssen Pharmaceutical Companies, and/or 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; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; 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 Annual Report on Form 10-K for the fiscal year ended January 2, 2022, 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 www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
References:
[1] Schinke C et al. Pivotal Phase 2 MonumenTAL-1 Results of Talquetamab, a GPRC5D×CD3 Bispecific Antibody, for Relapsed/Refractory Multiple Myeloma. Poster presentation (#8036) at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting.
[2] Padala SA et al. Epidemiology, Staging, and Management of Multiple Myeloma. Med Sci (Basel). 2021;9(1):3.
[3] Rajkumar SV, Kumar S. Multiple myeloma current treatment algorithms. Blood Cancer J. 2020;10(9):94.
[4] National Cancer Registry Ireland. Cancer Factsheet Multiple myeloma (ICD‐10 C90) Available at: https://www.ncri.ie/sites/ncri/files/factsheets/Dashboardv3.3_C90%20update.pdf Last accessed: October 2025
[5] National Cancer Registry Ireland, Cancer in Ireland 1994-2021. Annual Statistical Report 2023. Pg 9. Available at: https://www.ncri.ie/sites/ncri/files/pubs/NCRI_AnnualStatisticalReport_2023.pdf. Last accessed: October 2025.
[6] TALVEY Summary of Product Characteristics. Medicines.ie. https://www.medicines.ie/medicines/talvey-40-mg-ml-solution-for-injection-35527/spc Last accessed: October 2025
[7] ClinicalTrials.gov. Dose Escalation Study of Talquetamab in Participants with Relapsed or Refractory Multiple Myeloma (MonumenTAL-1). Available at: https://clinicaltrials.gov/ct2/show/NCT03399799. Last accessed: October 2025
[8] ClinicalTrials.gov. A Study of Talquetamab in Participants with Relapsed or Refractory Multiple Myeloma. Available at: https://clinicaltrials.gov/ct2/show/NCT04634552. Last accessed: October 2025
[9] ClinicalTrials.gov. A Study of the Combination of Talquetamab and Teclistamab in Participants with Relapsed or Refractory Multiple Myeloma (RedirecTT-1). Available at: https://clinicaltrials.gov/ct2/show/NCT04586426. Last accessed: October 2025
[10] ClinicalTrials.gov. A Study of Talquetamab and Teclistamab Each in Combination with a Programmed Cell Death Receptor-1 (PD-1) Inhibitor for the Treatment of Participants with Relapsed or Refractory Multiple Myeloma (TRIMM-3). Available at: https://clinicaltrials.gov/ct2/show/NCT05338775. Last accessed: October 2025
[11] ClinicalTrials.gov. A Study Comparing Talquetamab in Combination with Daratumumab or in Combination with Daratumumab and Pomalidomide Versus Daratumumab in Combination with Pomalidomide and Dexamethasone in Participants with Relapsed or Refractory Multiple Myeloma (MonumenTAL-3). Available at: https://clinicaltrials.gov/ct2/show/NCT05455320. Last accessed October 2025
[12] 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: https://clinicaltrials.gov/ct2/show/NCT04108195. Last accessed: October 2025
[13] ClinicalTrials.gov. A Study of Talquetamab with Other Anticancer Therapies in Participants with Multiple Myeloma (MonumenTAL-2). Available at: https://clinicaltrials.gov/ct2/show/NCT05050097. Last accessed: October 2025
[14] Conditional marketing authorisation. The European Medicines Agency. Available at: https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/conditional-marketing-authorisation. Last accessed: October 2025
[15] American Society of Clinical Oncology. Multiple myeloma: introduction. Available at: https://www.cancer.net/cancer-types/multiple-myeloma/introduction. Last accessed: October 2025
[16] National Cancer Registry Annual Report 2021. Available at: https://www.ncri.ie/sites/ncri/files/pubs/NCRI_Annual%20Report_2021.pdf Last accessed: October 2025
[17] American Cancer Society. Multiple myeloma: early detection, diagnosis and staging. Available at: https://www.cancer.org/content/dam/CRC/PDF/Public/8740.00.pdf. Last accessed: October 2025