CD3 stimulants(T cell surface glycoprotein CD3 stimulants), GPRC5D inhibitors(G-protein coupled receptor family C group 5member D inhibitors), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects)

Therapeutic Areas

NeoplasmsImmune System DiseasesHemic and Lymphatic Diseases+ [1]

Active Indication

Multiple MyelomaPeripheral Stem Cell TransplantationRefractory Multiple Myeloma+ [3]

Inactive Indication-

Originator Organization

Janssen Pharmaceuticals, Inc.

Active Organization

Janssen Research & Development LLC

Johnson & Johnson (China) Investment Ltd.

Janssen Pharmaceutica NV

+ [6]

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

United States (09 Aug 2023),

Multiple Myeloma

RegulationAccelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Priority Review (China), Breakthrough Therapy (China), Conditional marketing approval (China), Orphan Drug (South Korea), Conditional marketing approval (European Union), PRIME (European Union), Breakthrough Therapy (United States)

Structure/Sequence

Sequence Code 10086313H

Source: *****

Sequence Code 10086327L

Source: *****

Sequence Code 453116282H

Source: *****

Sequence Code 525754800L

Source: *****

Clinical Trials associated with Talquetamab

NCT06461988

/ Not yet recruitingPhase 2IIT

An Open-Label, Non-Randomized, Phase II Study to Study the Efficacy of Talquetamab (JNJ-64407564) and Lenalidomide as Post Stem Cell Transplant Maintenance in Multiple Myeloma (OPTIMMAL)

Multiple myeloma (MM) is a heterogenous plasma cell malignancy characterized by clonal proliferation of plasma cells and organ damage. Autologous transplantation with high dose chemotherapy is the standard of care in frontline treatment of eligible patients with MM.

Start Date01 Nov 2025

Sponsor / Collaborator

Stanford University

[+1]

NCT06572605

/ Not yet recruitingPhase 1/2IIT

A Phase 1b/2 Study of Talquetamab Plus Concomitant Priming Radiotherapy in Multiple Myeloma With Extramedullary Disease

This phase I/II trial tests the safety and effectiveness of extramedullary disease (EMD)-directed external beam radiation therapy (EBRT) in combination with talquetamab for the treatment of multiple myeloma patients with extramedullary disease. Extramedullary disease in multiple myeloma involves the infiltration of organs and soft tissues by malignant plasma cells and has proven difficult to treat. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink cancers. EBRT is a type of radiation therapy that delivers high-energy beams to the cancer from outside of the body. In this trial, the EBRT will be directed to a site of extramedullary disease. Talquetamab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Combining EMD-directed EBRT with talquetamab may be safe, tolerable, and/or effective in treating multiple myeloma patients with extramedullary disease.

Start Date01 Jul 2025

Sponsor / Collaborator

City of Hope National Medical Center

[+1]

NCT06827860

/ RecruitingPhase 2IIT

A Phase 2 Single-Arm Study of Subcutaneous Talquetamab in Elderly Patients With Multiple Myeloma in Early Relapse

Induction therapy approaches in recent years have evolved, now utilizing triple or quadruple drug regimens in the majority of patients. By combining anti-CD38 antibodies, proteasome inhibitors (PIs), immunomodulatory drugs (IMiDs), and steroids, patients achieve longer remissions with their first- and second-line therapies but also become refractory to most or all three major drug classes earlier. For patients who are refractory to at least 3 of the commonly administered PIs and IMiDs, occurring after 2 lines of therapy in many, the median overall survival is only 5 months. Elderly, frail patients are not often candidates at this point for aggressive therapies like stem cell transplantation and CAR T-cell therapy thus necessitating effective yet tolerable treatments for elderly patients in early relapse (1-3 prior therapy). Talquetamab is a GPRC5DxCD3 bispecific antibody that redirects patients' T cells to myeloma cells which express GPRC5D. In the phase 1 MonumenTAL-1, heavily pretreated patients with a median of 6 prior lines of therapy attained a 70% response rate with 405 μg/kg of subcutaneous (SC) talquetamab. Importantly, subcutaneous talquetamab was found to be tolerable for the treated population, which included 28% of patients aged ≥70, with only three patients experiencing dose-limiting toxicities in the form of grade 3 rashes which responded to steroids. The anti-CD38 antibody daratumumab eliminates CD38-positive T and B regulatory cells, potentiates the activity of bispecific antibodies like talquetamab, and may improve its efficacy when used in combination. The aim of this study will be to assess the efficacy and safety of treating elderly patients with relapsed/refractory multiple myeloma with at least ≥2 prior lines of therapy with subcutaneous talquetamab. Patients who have progressive disease on talquetamab or who fail to respond after 3 cycles will have subcutaneous daratumumab added to their regimen.

Start Date01 Jun 2025

Sponsor / Collaborator

Icahn School of Medicine at Mount Sinai

[+1]

100 Clinical Results associated with Talquetamab

100 Translational Medicine associated with Talquetamab

100 Patents (Medical) associated with Talquetamab

Literatures (Medical) associated with Talquetamab

01 May 2025·Clinical Lymphoma Myeloma & Leukemia

Comprehensive Review of Bispecific Antibody Constructs In Multiple Myeloma: Affinities, Dosing Strategies and Future Perspectives

Review

Author: Rasche, Leo ; Waldschmidt, Johannes M ; Einsele, Hermann ; Kortüm, K Martin

Despite significant advancements, multiple myeloma (MM) remains incurable, and there is still a pressing need for new therapeutic strategies with highly selective mechanisms of action and balanced off-target toxicity. In recent years, the development of "off-the-shelf" bispecific antibodies (bsAbs) has significantly enhanced our ability to treat relapsed or refractory MM. Teclistamab, elranatamab (both BCMA × CD3), and talquetamab (GPRC5D × CD3) are approved for treating MM patients who have received at least 3 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody. Meanwhile, the range of available bsAbs is rapidly expanding, offering patients and healthcare providers a broad selection of options that vary in target antigens, binding domains, construct designs, dosing regimens, and side effects. As linvoseltamab, alnuctamab, and ABBV-383 (all BCMA × CD3), as well as forimtamig (GPRC5D × CD3) and cevostamab (FcRH5 × CD3) progress through late-stage clinical development, emerging trispecific antibodies are now available that target either 2 different MM-associated antigens or provide additional co-stimulatory signals to prevent T-cell exhaustion. Despite this plethora of therapeutic options, resistance to bsAbs is an inevitability, and the optimal positioning of these drugs within the current MM treatment landscape remains to be determined. In this review, we examine the available data on all clinically accessible bsAbs, evaluating their potential, current limitations, and implications for efficacy and safety, with the aim of achieving deeper responses and longer overall survival for MM patients.

01 May 2025·EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY

Unveiling cardiovascular and respiratory toxicities with monoclonal antibodies in multiple myeloma: disproportionality analysis from the FDA Adverse Event Reporting System

Article

Author: Russo, Giulia ; Barbieri, Maria Antonietta ; Silvestris, Nicola ; Cicala, Giuseppe ; Spina, Edoardo ; Santarpia, Mariacarmela ; Andò, Giuseppe ; Franchina, Tindara

INTRODUCTION:

Monoclonal antibodies (mAbs) have revolutionized the treatment of multiple myeloma (MM), demonstrating remarkable effectiveness, despite potential adverse events (AEs). This study aims to identify unexpected signals of disproportionate reporting (SDRs) for cardiovascular (CV) and respiratory AEs associated with mAbs in MM treatment.

METHODS:

From January 2015 to December 2023, reports involving suspected drugs (daratumumab, elotuzumab, elranatamab, isatuximab, belantamab mafodotin, teclistamab, and talquetamab) were analyzed in the US Food and Drug Administration Adverse Event Reporting System (FAERS) database. Descriptive analysis was followed by disproportionality analyses first comparing mAbs to all other drugs (reference group, RG1), and subsequently conducting a sensitivity analysis against other MM drugs (RG2).

RESULTS:

Out of 13,496,241 reports, 31,052 (0.2%) were associated with MM, with 6574 (0.1%) linked to CV and respiratory adverse events, primarily involving older population (n = 3441; 52.3%) and male (n = 3338; 50.8%) patients. Disproportionality analyses identified unexpected SDRs for daratumumab, including cardiac failure (n = 322; RG1: ROR = 4.74, CI 95% = 4.24-5.29; RG2: ROR = 4.42, 95% CI = 3.91-4.99), embolic and thrombotic event, such as pulmonary embolism (162; RG1: 2.44, 2.09-2.85), deep vein thrombosis (126; RG1: 2.95, 2.47-3.52), and respiratory failure (192; RG1: 4.06, 3.52-4.68; RG2: 4.2, 3.59-4.91). Isatuximab was linked to cardiac arrhythmia, such as atrial fibrillation (46; RG1: 2.54, 1.9-3.4; RG2: 1.35, 1.01-1.81), embolic and thrombotic event, including deep vein thrombosis (26; RG1: 2.93, 1.99-4.3) and pulmonary embolism (89; RG1: 6.56, 5.32-8.1; RG2: 2.93, 2.37-3.63). Elotuzumab showed also SDRs for atrial fibrillation (56; RG1: 3.68, 2.82-4.79; RG2: 1.96, 1.5-2.56) and deep vein thrombosis (41; RG1: 5.49, 4.03-7.47).

CONCLUSION:

Unexpected CV and respiratory AEs with clinical relevance not previously reported in literature have been identified underlining the importance of pharmacovigilance.

01 Apr 2025·HemaSphere

A German multicenter real‐world analysis of talquetamab in 138 patients with relapsed/refractory multiple myeloma

Article

Author: Michel, Christian S. ; Fenk, Roland ; Hänel, Mathias ; Bewarder, Moritz ; Kolditz, Katja ; Theurich, Sebastian ; Kull, Miriam ; Dampmann, Maria ; Trautmann‐Grill, Karolin ; Besemer, Britta ; Bassermann, Florian ; Khandanpour, Cyrus ; Brunner, Franziska ; Frenking, Jan H. ; Högner, Marion ; Gezer, Deniz N. ; Leitner, Theo ; Krönke, Jan ; Zukovs, Romans ; Teipel, Raphael ; Rasche, Leo ; Landrin, Valentine ; Hanoun, Christine ; Wäsch, Ralph ; Goldman‐Mazur, Sarah ; Raab, Marc S. ; Kos, Igor ; Merz, Maximilian ; Müller‐Tidow, Carsten ; Brioli, Annamaria ; Riedhammer, Christine ; von Metzler, Ivana ; Braune, Jan

Abstract:

Bispecific T‐cell engagers (BTCEs) represent a paradigm shift in the treatment of relapsed/refractory multiple myeloma (RRMM). Talquetamab, a GPRC5DxCD3 BTCE, has shown promising results in the MonumenTAL‐1 trial and was recently approved by the Food and Drug Administration and the European Medicines Agency. However, treatment under real‐world conditions may not represent patient characteristics in clinical trials with restricted enrollment criteria. We performed a retrospective real‐world analysis including 138 RRMM patients treated with talquetamab at 21 German centers. Of evaluable patients, 43% had ISS stage III, 37% had extraosseous disease, and 48% had high‐risk cytogenetics. After a median of six prior therapy lines, 58% of patients would not have been eligible for MonumenTAL‐1. With a median follow‐up of 8.2 months, we observed an overall response rate of 65% and a median progression‐free survival of 6.4 months (95% confidence interval 5.1–9.0). Prior BTCE exposure, ISS stage III, extraosseous disease, and penta‐drug refractory disease were associated with unfavorable outcomes. Grade ≥ 3 cytokine release syndrome and neurotoxicity occurred in 5.1% and 1.5% of patients, respectively. In summary, our real‐world study confirms the efficacy and safety of talquetamab, despite a high proportion of patient‐ and disease‐related risk factors. These results support its use as bridging or long‐term treatment, even in advanced stages.

114

News (Medical) associated with Talquetamab

24 Mar 2025

·www.prnewswire.com

CARVYKTI Continued Performance Reflects Growing Confidence in CAR-T Therapies for Multiple Myeloma | DelveInsight

As a BCMA-targeting CAR T-cell therapy, CARVYKTI addresses a high unmet need in relapsed or refractory multiple myeloma patients. With promising clinical efficacy, durable responses, and growing adoption in advanced treatment lines, CARVYKTI is poised for substantial revenue growth. LAS VEGAS, March 24, 2025 /PRNewswire/ -- DelveInsight's " CARVYKTI Market Size, Forecast, and Market Insight Report" highlights the details around CARVYKTI, a BCMA-directed, genetically modified autologous T-cell immunotherapy, which involves reprogramming a patient's T cells with a transgene encoding a CAR that identifies and eliminates cells that express BCMA. The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of CARVYKTI. The report also highlights the historical and forecasted sales from 2020 to 2034 segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Janssen's CARVYKTI (ciltacabtagene autoleucel) Overview CARVYKTI is an autologous T-cell immunotherapy that targets B-cell maturation antigen (BCMA). It works by genetically modifying a patient's T cells with a transgene that encodes a chimeric antigen receptor (CAR). This CAR helps the T cells recognize and destroy cells expressing BCMA, which is primarily found in malignant multiple myeloma B-lineage cells, late-stage B cells, and plasma cells. The CARVYKTI CAR protein includes two single-domain antibodies designed to bind strongly to human BCMA, enhancing T-cell activation, proliferation, and the destruction of target cells upon binding. Currently, CAR-T cell therapies are only available to UK patients through clinical trials. Janssen recently decided not to proceed with seeking approval for cilta-cel (CARVYKTI) for myeloma patients in the UK through the National Institute for Health and Care Excellence (NICE). This decision means cilta-cel will not be available on the NHS for now, although it remains accessible through clinical trials. Janssen's decision does not impact ongoing trials. The drug is currently being evaluated in Phase III trials: CARTITUDE-6 for frontline multiple myeloma transplant eligible vs ASCT and CARTITUDE-5 for frontline multiple myeloma TNI. In 2024, CARVYKTI generated sales of USD 963 million across the world. CARVYKTI Dosage and Administration CARVYKTI is administered as a single infusion containing a suspension of CAR-positive, viable T cells in one infusion bag. The recommended dosage ranges from 0.5 to 1.0 × 10⁶ CAR-positive viable T cells per kilogram of body weight, with a maximum limit of 1 × 10⁸ CAR-positive viable T cells per infusion. Learn more about CARVYKTI projected market size for multiple myeloma @ CARVYKTI Market Potential CAR-T cell immunotherapy is emerging as a revolutionary treatment for multiple myeloma, offering new hope to patients who have exhausted conventional treatment options. Currently, only two CAR-T cell therapies are approved for multiple myeloma: ABECMA (idecabtagene vicleucel) from Bristol-Myers Squibb and CARVYKTI (ciltacabtagene autoleucel) from Johnson & Johnson Innovative Medicine. Their approval highlights the potential of CAR-T therapy to transform multiple myeloma treatment. A key advantage of CAR-T therapies is their "one-and-done" nature, requiring a single administration, unlike bispecific antibodies such as TECVAYLI and TALVEY, which need ongoing dosing. Present CAR-T therapies use a patient's own T cells (autologous), but research is underway to develop allogeneic CAR-T cells derived from healthy donors. Allogeneic therapies could offer off-the-shelf solutions, enhancing accessibility and lowering costs. The approval of CAR-T therapies has created new opportunities for companies focused on advanced-stage multiple myeloma (fourth line and beyond). Several companies are progressing with their CAR-T candidates at different stages of development. The CAR-T cell therapy market for multiple myeloma is expected to grow significantly between 2024 and 2034, driven by its high efficacy and potential for expanded use. Collaboration between pharmaceutical companies and research institutions, along with ongoing innovation, is expected to accelerate market growth. However, challenges such as manufacturing complexity and pricing will need to be addressed to unlock the full potential of CAR-T therapies. Discover more about the CAR T-cell therapy for multiple myeloma market in detail @ CAR T-cell Therapy for Multiple Myeloma Market Report Emerging Competitors of CARVYKTI Some of the CAR-Ts in the multiple myeloma pipeline that will give fierce competition to CARVYKTI include Anito-cel (Arcellx), PHE885 (Novartis), BMS-986393 (Bristol-Myers Squibb), Zevorcabtagene Autoleucel (CARsgen Therapeutics), and GLPG5301 (Galapagos), among others In December 2024, Arcellx announced encouraging new data from its Phase II pivotal iMMagine-1 trial for anito-cel in multiple myeloma. The results were presented during an oral session at the 66th American Society of Hematology (ASH) Annual Meeting on Monday, December 9, 2024, at 5:30 p.m. PT. Also at ASH 2024, BMS shared the first overall survival (OS) and progression-free survival (PFS) results for arlo-cel in an oral presentation. The Phase I trial involved patients with relapsed or refractory multiple myeloma who had previously undergone at least three treatments, including a proteasome inhibitor, an immunomodulatory drug, and anti-CD38 therapy. Among 79 patients evaluable for efficacy, with a median follow-up of 16.1 months (range: 2.8–25.2), arlo-cel showed an overall response rate (ORR) of 87%, indicating durable responses. Minimal residual disease (MRD) was assessed as an exploratory measure, with 57% (48 of 84) of MRD-evaluable patients included. Of these, 46% (22 of 48) were MRD-negative and achieved a complete response (CR) or stringent CR (sCR). Across all treated patients, 27% (23 of 84) were MRD-negative and achieved a CR. Median PFS was 18.3 months (95% CI: 11.8–21.9), while the median OS had not yet been reached. To know more about the number of competing drugs in development, visit @ CARVYKTI Market Positioning Compared to Other Drugs Key Milestones of CARVYKTI In April 2024, Johnson & Johnson announced that the US FDA approved CARVYKTI (ciltacabtagene autoleucel; cilta-cel) for the treatment of adult patients with RRMM who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent, and are refractory to lenalidomide. In March 2024, Johnson & Johnson announced that the US FDA Oncologic Drugs Advisory Committee (ODAC) recommends CARVYKTI for the treatment of adult patients with RRMM who have received at least one prior line of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD) and who are refractory to lenalidomide. In February 2024, Johnson & Johnson announced that the Committee for Medicinal Products for Human Use (CHMP) of the EMA recommended the approval of a Type II variation for CARVYKTI for the earlier treatment of RRMM. In September 2022, Legend Biotech announced that Japan's Ministry of Health, Labour and Welfare (MHLW) had approved CARVYKTI (ciltacabtagene autoleucel) for the treatment of adults with relapsed or refractory multiple myeloma, limited to cases meeting both of the following conditions including patients having no history of CAR-positive T-cell infusion therapy targeting BCMA and patients who have received three or more lines of therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 monoclonal antibody, and in whom multiple myeloma has not responded to or has relapsed following the most recent therapy. In May 2022, Janssen announced that the European Commission (EC) granted conditional marketing authorization for CARVYKTI for the treatment of adults with relapsed and refractory multiple myeloma (RRMM) who have received at least three prior therapies, including an immunomodulatory agent (IMiD), a proteasome inhibitor (PI) and an anti-CD38 antibody, and have demonstrated disease progression on the last therapy. In February 2022, Janssen announced that the US FDA had approved CARVYKTI (ciltacabtagene autoleucel; cilta-cel) for the treatment of adults with relapsed or refractory multiple myeloma (RRMM) after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. In August 2020, Legend Biotech announced that the China Center for Drug Evaluation, National Medical Products Administration (CDE, NMPA) had recommended BTD for ciltacabtagene autoleucel (cilta-cel; LCAR-B38M CAR-T cells) for the treatment of adults with relapsed or refractory multiple myeloma. In December 2019, Janssen announced receipt of a BTD from the US FDA for cilta-cel. In April 2019, the EMA granted a PRIME (PRIority MEdicines) designation for the company's investigational BCMA CAR-T therapy. In February 2019, the US FDA granted ODD for cilta-cel (JNJ-4528), and in February 2020, the European Commission also granted orphan designation for this drug. In December 2017, Janssen entered a worldwide collaboration and license agreement with Legend Biotech to jointly develop and commercialize LCAR-B38M in multiple myeloma Discover how CARVYKTI is shaping the multiple myeloma treatment landscape @ CARVYKTI CAR-T CARVYKTI Market Dynamics The market for CARVYKTI is driven by the increasing prevalence of multiple myeloma and the growing demand for innovative therapies that can address the limitations of existing treatments, such as proteasome inhibitors and immunomodulatory drugs. The competitive landscape includes other BCMA-targeting therapies, such as Bristol Myers Squibb's ABECMA (idecabtagene vicleucel), which was the first BCMA-directed CAR-T therapy approved for multiple myeloma. CARVYKTI's strong clinical efficacy, coupled with its potential for long-term remission, gives it a competitive edge, but challenges related to manufacturing scalability, logistical complexities, and high treatment costs could impact its market penetration and patient accessibility. Strategic partnerships and ongoing clinical development will play a key role in expanding CARVYKTI's market reach. Janssen and Legend Biotech are actively working to improve manufacturing processes to reduce vein-to-vein time and address supply chain bottlenecks. Furthermore, ongoing trials, such as CARTITUDE-4, are exploring CARVYKTI's use in earlier lines of therapy, which could significantly expand its patient base and market potential. If successful in earlier settings, CARVYKTI could shift the treatment paradigm for multiple myeloma and increase adoption among physicians and healthcare providers. Despite its promising clinical profile, CARVYKTI faces challenges related to reimbursement and healthcare infrastructure. The high cost of CAR-T therapies often limits patient access, particularly in markets with strict reimbursement policies. Moreover, the complex nature of CAR-T administration, which requires specialized centers and trained personnel, adds to the barriers. However, continued clinical success, regulatory support, and improvements in manufacturing and delivery infrastructure could strengthen CARVYKTI's market position and establish it as a cornerstone therapy in the multiple myeloma treatment landscape. Dive deeper to get more insight into CARVYKTI's strengths & weaknesses relative to competitors @ CARVYKTI Market Drug Report Table of Contents Related Reports Relapsing Refractory Multiple Myeloma Market Relapsing Refractory Multiple Myeloma Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key RRMM companies including AbbVie, Genentech, Amgen, Onyx Therapeutics Inc., Bristol-Myers Squibb, MedImmune LLC, Novartis Pharmaceuticals, Incyte Corporation, Takeda, among others. Relapsing Refractory Multiple Myeloma Pipeline Relapsing Refractory Multiple Myeloma Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key RRMM companies, including Bristol-Myers Squibb, I-MAB Biopharma, Pfizer, Arcellx, Gilead Sciences, Novartis, Array Biopharma, Hrain Biotechnology Co., Ltd., Cartesian Therapeutics, Xencor, Takeda, Sorrento Therapeutics, Heidelberg Pharma AG, Ichnos Sciences, Allogene Therapeutics, Harpoon Therapeutics, Cellectis, Poseida Therapeutics, Regeneron Pharmaceuticals, ONK Therapeutics, TeneoOne, iTeos Therapeutics, Oricell Therapeutics, Anaveon AG, Luminary Therapeutics, Seagen Inc., Trillium Therapeutics Inc., Virtuoso BINco, Inc., Seagen Inc., Trillium Therapeutics Inc., among others. Multiple Myeloma Market Multiple Myeloma Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key multiple myeloma companies including Sanofi, Karyopharm Therapeutics, AbbVie, Takeda Pharmaceutical, Celgene, Bristol-Myers Squibb, RAPA Therapeutics, Pfizer, Array Biopharma, Cellectar Biosciences, BioLineRx, Celgene, Aduro Biotech, ExCellThera, Janssen Pharmaceutical, Precision BioSciences, Takeda, Glenmark (Ichnos Sciences SA), Poseida Therapeutics, Molecular Partners AG, Chipscreen Biosciences, AbbVie, Genentech (Roche), Janssen Biotech, Nanjing Legend Biotech, Merck Sharp & Dohme Corp., among others. Multiple Myeloma Pipeline Multiple Myeloma Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key multiple myeloma companies, including CASI Pharmaceuticals, Carsgen Therapeutics, Cartesian Therapeutics, Gracell Biotechnology Shanghai Co., Ltd., Sorrento Therapeutics, TeneoOne, Karyopharma Therapeutics, Arcellx, Poseida Therapeutics, Ichnos Sciences, Nerviano Medical Sciences, Bristol Myers Squib, Ascentage Pharma, Ionis Pharmaceuticals, Chongqing Precision Biotech Co., Ltd., CRISPR Therapeutics, AstraZeneca, IGM Biosciences, Novartis, GlaxoSmithKline, Innovent Biologics, Keymed Biociences, Starton Therapeutics, Takeda, Fate Therapeutics, Gilead Sciences, Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd., Janssen Pharmaceutical, Nanjing IASO Biotechnology Co., Ltd., GPCR Therapeutics, Chimerix, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultImmunotherapyOrphan DrugDrug ApprovalPhase 3

05 Mar 2025

·www.biospace.com

10 Best-Selling Drugs of 2024 Rake in Billions Amid Exclusivity Threats

iStock, leolintang Merck’s Keytruda holds on to the top spot while AbbVie’s Humira—once the world’s top-selling drug—continues to cede its market share to biosimilar competitors. For six years straight, AbbVie’s Humira reigned as the world’s best-selling drug. The anti-TNF antibody bowed only to Pfizer and BioNTech’s COVID-19 vaccine Comirnaty in 2021, and yet even in the throes of the pandemic—when anti-infectives saw a surge in demand—Humira stood its ground, staying in the top three earners of the year. In 2024, however, it became clear that Humira is no longer the dominant market force that it once was. Mounting biosimilar and competitive pressure have sent Humira’s sales steadily downward. The drug is no longer AbbVie’s biggest moneymaker and the pharma appears to no longer be investing in its growth. As per its latest pipeline update document , posted in January, AbbVie has no active studies or applications for Humira. Humira’s fall is emblematic of the typical life cycle of drugs. John Gagliano, senior director at BioPharmCatalyst, expects to see a similar pattern play out in the coming years, as the industry faces the strongest patent headwinds in more than a decade. “The overall landscape [of top drugs] is anticipated to become more diverse as emerging therapies gradually replace aging blockbusters,” he told BioSpace in an email. Companies can implement what Gagliano calls “defensive strategies” such as novel formulations, patent extensions and combination regimens to prolong the exclusivity of their drugs and “sustain their positions” in the market—but that only serves to delay the inevitable. “Many current top sellers face imminent loss of exclusivity (LOE), which will likely trigger rapid revenue declines,” Gagliano continued. In addition to Humira, Eliquis and Opdivo are likely to “drop out of the top ranks as biosimilars and generics enter the market,” predicts Gagliano’s colleague Olivia Tidwell, content coordinator at BioPharmCatalyst. Meanwhile, she continued, potentially rising to take their place are promising assets in emerging modalities, such as radioligand therapies, CAR Ts and gene therapies, among others. Here, BioSpace looks at the top 10 pharma products that brought in the biggest sales in 2024. The list is a mix of predictable and surprising. Novo Nordisk’s Ozempic, for instance, was pretty much a shoo-in for this list, while several drugs facing LOE concerns—and were therefore expected to suffer slower sales—managed to maintain their market dominance. Merck’s Keytruda Tops Again—But for How Long? 2024 Sales: $29.5 billion YOY Change: 18% For the second year in a row, Merck’s blockbuster PD-1 inhibitor Keytruda tops the list of pharma’s best-selling products. In 2024, Keytruda surged 18% year-on-year to hit $29.48 billion in sales . The feat comes as no surprise given how Keytruda has become a cornerstone cancer therapy with more than 40 indications under its belt, including various forms of lung and gynecological cancers. Most recently, the FDA approved Keytruda for the first-line treatment of pleural mesothelioma, giving Merck access to a market that could exceed $12 billion in value by 2034, as per an August 2024 IMARC report . But trouble could be brewing on Keytruda’s horizon. Key patents protecting Merck’s blockbuster are set to expire in 2028, opening it up to biosimilar competition and, in turn, eroding sales. There also appears to be growing regulatory apprehension regarding the widespread use of Keytruda—and PD-1 inhibitors more broadly. In September 2024, an FDA advisory panel overwhelmingly voted to narrow the label of Keytruda, along with Bristol Myers Squibb’s Opdivo and Yervoy, in stomach and esophageal cancers, restricting their use in patients with low PD-1 expression levels. The FDA has yet to put out a formal directive. Merck is doing what it can to maintain Keytruda’s market dominance. The pharma is developing a subcutaneous formulation of the PD-1 blocker that could help maintain an edge over potential copycats. “Unlike Humira’s steep post-LOE slide, Keytruda’s lifecycle management measures suggest it will retain significant market share, albeit potentially at a lower rank,” BioPharmCatalyst analyst Cristian Marulanda told BioSpace in an email. “Merck’s proactive strategies and continuous innovation may help Keytruda weather competitive pressures better than past examples.” IRA Threatens Rise of Novo’s Ozempic 2024 Sales: $16.9 billion YOY Change: 26% It comes as a surprise to no one that the widely popular type 2 diabetes drug Ozempic is among the top-performing drugs of 2024. In its full-year business report, Novo Nordisk revealed that the GLP-1 therapy made more than 120 billion Danish kroner last year, or approximately $16.9 billion. Ozempic was one of the highest-growth assets on this list—relative to 2023, Ozempic’s sales jumped 26%—and it is poised to see an even greater upward trend in coming years. Originally approved in 2017 to improve glycemic control, Ozempic secured additional approvals in 2020 to reduce cardiovascular risk and in January 2025 to lower the likelihood of chronic kidney disease. Getting in the way of Ozempic’s growth, however, is the Inflation Reduction Act (IRA). Earlier this year, the Centers for Medicare and Medicaid Services (CMS) selected the GLP-1 drug—alongside sister brand Rybelsus—for the second round of drug price negotiations. The move was not entirely unexpected . Over the past year, Novo was on the receiving end of several high-profile calls to lower the list price of Ozempic. Faced with the prospects of a price cap on Ozempic, Novo has asked the U.S. Court of Appeals for the Third Circuit to speed up proceedings regarding its ongoing complaint against the IRA. Novo alleges that the price negotiations are in violation of its constitutional rights—an argument that has so far failed to convince judges. Biktarvy Sales Symbolize Gilead’s Strong Standing 2024 Sales: $13.4 billion YOY Change: 13% Building off the size of the HIV market is Gilead’s antiretroviral drug Biktarvy, which in 2024 jumped 13% to bring in $13.42 billion in sales, growth that the pharma attributed to “higher demand” for the drug. Biktarvy is currently the cornerstone of Gilead’s HIV business. It “commands over 50% share of the U.S. market” and is the “regimen of choice” across many markets, commercial chief Johanna Mercier said during the company’s fourth-quarter investor call. Unlike Keytruda and Ozempic, there are no clear headwinds in Biktarvy’s immediate future. Key patent protections for the drug will remain intact in the coming years and will keep generic competitors off the market until 2033. Biktarvy also escaped the CMS’s list for the second cycle of drug negotiations. Still, Biktarvy isn’t a completely risk-free asset for Gilead, and the prospects of price control problems remain on the horizon. In a note to investors in February 2025, analysts at BMO Capital Markets said that they are wary of the drug’s “likely inclusion” in the 2028 cycle of IRA negotiations. BMS, Pfizer Brace for Eliquis LOE 2024 Sales: $13.3 billion YOY Change: 9% The blood thinner Eliquis—developed and commercialized through the powerhouse partnership between Bristol Myers Squibb and Pfizer— made $13.3 billion in 2024, representing a 9% year-on-year increase in sales. The drug has long been a prized asset for both companies, but that may soon be coming to an end. Eliquis is set to lose market exclusivity in 2026—with several generics already lined up, eager to enter the U.S. market and eat into the drug’s earnings. Among these are copycats from Mylan Pharmaceuticals and Micro Labs Limited, which the FDA approved as early December 2019 . Eliquis was also in the first batch of drugs that underwent the CMS drug price negotiations last year. The final maximum fair price of $231 for a 30-day supply, set to take effect in 2026, is a 56% discount from the original cost, though it was already selling below list price . To cope with the potential loss of revenue from Eliquis, BMS has kicked a multibillion-dollar savings initiative into motion, targeting $1.5 billion in cost-cuts by the end of 2025 and another $2 billion through 2027. Pfizer is taking a similar approach, setting a $3.5 billion savings goal in 2024 and tacking on another $1.5 billion by the end of 2027. Sanofi, Regeneron Rely on Robust Dupixent Figures 2024 Sales: $13 billion YOY Change: 23% Sanofi and Regeneron are jointly commercializing the immunology heavy-hitter Dupixent, which last year bagged $13.072 billion , representing 23% year-on-year growth. Like Biktarvy, Dupixent appears to have no patent- and IRA-related issues on its horizon. The drug will retain market exclusivity until 2031 and is looking at promising market prospects, too. The FDA in September 2024 approved Dupixent for the treatment of chronic obstructive pulmonary disease, for which launch is expected this year . Still, analysts at William Blair in a January 2025 report cautioned that Regeneron and Sanofi are “extremely reliant on Dupixent,” with “little else to be excited about” in their pipelines. Regeneron, for instance, has been trying to get its high-dose Eylea brand off the ground with limited success so far. In the fourth quarter, Eylea HD brought in $305 million, below the projected $336 million consensus. Sanofi, meanwhile, is a “bit of a one-trick pony with respect to near-term growth drivers,” according to the William Blair report. Vaccines account for around 15% of its revenue and this space faces considerable exposure due to volatility linked to changes in government policies, the firm wrote. AbbVie’s Skyrocketing Skyrizi 2024 Sales: $11.7 billion YOY Change: 50.9% AbbVie’s answer to Humira’s fall, the anti-IL-23 therapy Skyrizi, is the fastest-growing asset on this list. With a 50.9% year-on-year increase in sales, Skyrizi raked in $11.718 billion for the Illinois pharma in 2024, easily surpassing Humira’s nearly $9 billion earnings. That Skyrizi finds itself on this list is evidence of how well AbbVie handled the lapsed protections for Humira, which for years was the world’s top-selling drug. In the third quarter of 2024, sales of Skyrizi—alongside the JAK inhibitor Rinvoq—helped AbbVie narrowly beat analysts’ expectations , despite continued erosion of Humira’s sales. This trend continued into the fourth quarter. In a Feb. 1 note from BMO Capital Markets, in reaction to the pharma’s full-year business report, analysts said that Skyrizi and Rinvoq are set to “usher in a new era of growth” for AbbVie, which has “finally fully moved on from the narrative of the Humira LOE.” Skyrizi’s immediate future is clear of patent concerns. Market exclusivity is set to last until 2031, as per the January William Blair report. Likewise, Rinvoq’s protections will remain intact into 2033. J&J Offsets Stelara Losses With Darzalex Growth .tg {border:none;border-collapse:collapse;border-spacing:0;} .tg td{border:none;border-collapse:collapse;border-spacing:0;font-family:Arial, sans-serif;font-size:14px;overflow:hidden; padding:10px 5px;word-break:normal;} .tg th{border:none;border-collapse:collapse;border-spacing:0;font-family:Arial, sans-serif;font-size:14px;font-weight:normal; overflow:hidden;padding:10px 5px;word-break:normal;} .tg .tg-ej4a{border:none;border-collapse:collapse;border-spacing:0;font-family:Arial, Helvetica, sans-serif !important;font-size:18px;text-align:left; vertical-align:top} Darzalex 2024 Sales: $11.6 billion YOY Change: 20% Stelara 2024 Sales: $10.4 billion YOY Change: -4.6% J&J had two top-selling drugs in 2024: one on its way in, the other on its way out. Stelara, an anti-IL-12 and IL-23 antibody indicated for various inflammatory diseases, lost key patent protections in September 2023 . Biosimilars have since entered the U.S market and, while not yet completely unseating Stelara, have eroded its sales. In 2023, the biologic made $10.86 billion . Last year, sales were down 4.6% to $10.34 billion. To make up for lost revenue, J&J is leaning on its cancer drug Darzalex, an anti-CD38 cytolytic antibody approved for multiple myeloma. In 2024, Darzalex brought in $11.67 billion, representing nearly 20% year-on-year growth. According to the William Blair report, Darzalex will help drive J&J’s cancer franchise—including its CAR T therapy Carvykti and bispecific antibodies Tecvayli and Talvey—to 15.3% compounded annual growth, hitting $27.1 billion in sales by 2029. J&J continues to work on expanding Darzalex’s label, including a September 2024 FDA filing that would allow the drug’s use in patients with newly diagnosed multiple myeloma who are ineligible for stem cell transplantation, as well as a November 2024 submission for high-risk smoldering multiple myeloma. Darzalex will retain key patent protections until 2029, as per William Blair. Humira: On its Way Out? 2024 Sales: $9 billion YoY Change: -37.6% Sustaining a 37.6% year-on-year decline in sales, Humira is now clearly beyond its prime. In 2024, the once-dominant anti-inflammatory therapy brought in $8.993 billion for AbbVie. The obvious culprit for Humira’s fall from grace is growing biosimilar competition. Since the drug lost key patent protections in 2023, several copycats have hit the market, including Amgen’s Amjevita, Celltrion’s Yuflyma, Cordavis and Sandoz’s Hyrimoz and Boehringer Ingelheim’s Cyltezo. Another major driver of Humira’s market erosion is CVS Caremark’s move in April 2024 to remove the branded drug from its major national formularies in favor of biosimilars, including its own adalimumab brand Hyrimoz. Cordavis is a CVS Caremark subsidiary launched in August 2023. Humira is putting up a commendable fight, though. In the first-quarter 2025 edition of Samsung Bioepis’ Biosimilar Market Dynamics report , Humira remains the top adalimumab brand, controlling 72% of the market. In the third-quarter 2024 edition of the same report, Humira still had 82% market share . Merck’s Gardasil Hangs On Amid Controversy 2024 Sales: $8.6 billion YoY Change: -3% The only vaccine on this list, Merck’s human papillomavirus shot Gardasil saw a 3% drop in sales in 2024, bringing in $8.58 billion . The jab’s prospects don’t look good. Key patent protections are set to expire in 2028, according to William Blair, though there appear to be no notable biosimilars on the horizon. More importantly for Merck and Gardasil are questions surrounding how U.S. health authorities will handle vaccines moving forward with Robert F. Kennedy Jr.—a known vaccine critic—as Secretary of Health and Human Services . In addition, last month, Merck announced that Gardasil shipments to China would be suspended amid stubbornly high inventories of the vaccine, a result that CEO Rob Davis blamed on “increased pressure on discretionary consumer spending” on the pharma’s most recent earnings call. Gardasil was recently approved for males in China.

Drug ApprovalVaccine

22 Jan 2025

·www.biopharmadive.com

J&J oncology sales grow, but shares slide on outlook

Dive Brief:Johnson & Johnson on Wednesday reported modestly higher-than-expected earnings for the fourth quarter, while cautioning that unfavorable currency exchange rates would temper sales growth this year.Adjusted earnings per share reached $2.04 in the fourth quarter, higher than the Wall Street consensus of $2.01 and Leerink Partners estimate of $1.96, Leerink analyst David Risinger wrote in a note to clients. The companys sales rose 5.3% to $22.5 billion during the quarter, in line with estimatesFull-year 2024 revenue increased to $88.8 billion from $85.2 billion in 2023. For this year, J&J expects revenue to climb to between $89.2 billion and $90 billion, with a mid-point of $89.6 billion, less than the consensus estimate of $91.1 billion. Shares of the company dropped about 3% in early trading Wednesday, even as the overall market rose.Dive Insight:CEO Joaquin Duato is looking to newer medicines to drive J&Js sales growth as the company fights through generic competition for its second-best selling drug, Stelara. Worldwide sales of Stelara dropped 15% to $2.3 billion in the fourth quarter, with most of the decline coming from overseas, where copycat competition already has a toehold. In the U.S., Amgen recently launched the first biosimilar of Stelara and more are on the way.Even so, J&J is poised for sustained growth through this decade, Duato said. I cannot think of any other company that would be able to deliver growth through the first year of losing exclusivity of a multibillion-dollar product, Duato told analysts on a conference call.That growth will depend in large part on the continued success of the companys cancer medicines, led by Darzalex. Sales of the drug jumped 21% to $3.1 billion in the fourth quarter. At the same time, J&Js Carvykti, a CAR-T treatment for multiple myeloma, came close to breaking $1 billion in sales for the year. J&J will also be looking for growth from newer medicines including Tecvayli and Talvey.Outside of oncology, J&Js depression treatment Spravato brought in sales of $1.1 billion for the year, a 56% increase from the previous year. And the drug will benefit in 2025 from an expanded Food and Drug Administration approval in people with treatment-resistant depression.J&J also plans to expand its psychiatric offerings with the $14.6 billion acquisition of Intra-Cellular Therapies announced last week. Intra-Cellular sells a drug called Caplyta for schizophrenia and bipolar disorder and is looking to expand its use for patients with major depressive disorder. '

AcquisitionCell Therapy

100 Deals associated with Talquetamab

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Multiple Myeloma	United States	Janssen Biotech, Inc.	09 Aug 2023

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Refractory Multiple Myeloma	Phase 3	United States	Janssen Research & Development LLC	20 Oct 2022
Refractory Multiple Myeloma	Phase 3	Poland	Janssen Research & Development LLC	20 Oct 2022
Peripheral Stem Cell Transplantation	Phase 2	United States	Janssen Scientific Affairs LLC	01 Nov 2025
Smoldering Multiple Myeloma	Phase 2	United States	Janssen Scientific Affairs LLC	04 Dec 2023
Relapse multiple myeloma	Phase 2	United States	Janssen Research & Development LLC	01 Feb 2021
Relapse multiple myeloma	Phase 2	China	Janssen Research & Development LLC	01 Feb 2021
Relapse multiple myeloma	Phase 2	Japan	Janssen Research & Development LLC	01 Feb 2021
Relapse multiple myeloma	Phase 2	Belgium	Janssen Research & Development LLC	01 Feb 2021
Relapse multiple myeloma	Phase 2	France	Janssen Research & Development LLC	01 Feb 2021
Relapse multiple myeloma	Phase 2	Germany	Janssen Research & Development LLC	01 Feb 2021

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04586426 (RedirecTT-1, Pubmed) Manual	Phase 1/2	Multiple Myeloma \| Refractory Multiple Myeloma	94	Talquetamab + Teclistamab	nkzlxfdwdv(wfffccyfqz) = pzvsmynrju wlbbilnsib (isizwsapnm ) View more	Positive	09 Jan 2025
				Talquetamab 0.8 mg/kgTalquetamab 0.8 mg/kg + Teclistamab 3.0 mg/kgTeclistamab 3.0 mg/kg (RP2R)	kntnrtykvu(ppjwlzsfer) = druboosbdr ctxkvkfhak (xfoxryzzul ) View more
ASH2024	Not Applicable	Refractory Multiple Myeloma	-	Talquetamab 0.4 mg/kg weekly	dgyzpyemdm(wproxuxyvn) = idxemzztym juehhturwq (odpvymwytr ) View more	-	08 Dec 2024
				Talquetamab 0.8 mg/kg every other week	dgyzpyemdm(wproxuxyvn) = trtsjvjxwq juehhturwq (odpvymwytr ) View more
ASH2024	Not Applicable	Multiple Myeloma	-	Talquetamab 0.6 mg/kg Q2W	lnhjrbpjnc(yfscjkkdgw) = Cytokine release syndrome (CRS) were graded by American Society of Transplantation and Cellular Therapy criteria; all other adverse events (AEs) were graded by Common Terminology Criteria for Adverse Events v5.0. wmyvbzzfxs (vwwzhjrtkk ) View more	-	07 Dec 2024
				Talquetamab 0.8 mg/kg Q4W
NCT03399799 \| NCT04634552 (MonumenTAL-1, SOHO2024)	Phase 1/2	Multiple Myeloma GPRC5D \| CD3	375	Talquetamab 0.4 mg/kg QW	djwwszqfhg(bkbpgtqnnd) = Early onset of GPRC5Drelated AEs was associated with a higher likelihood of response rjgbycxskh (gcpawsnzwi ) View more	Positive	04 Sep 2024
				Talquetamab 0.8 mg/kg Q2W
SOHO2024	Not Applicable	Multiple Myeloma	-	Talquetamab 0.4 mg/kg QW	muxasprulo(vbjhtimwek) = 74.3% (most grade 1/2, 1 grade 3) lutxsqifiq (qhkpfuhnft ) View more	-	04 Sep 2024
				Talquetamab 0.8 mg/kg Q2W
NCT03399799 \| NCT04634552 (MonumenTAL-1, ASCO2024) Manual	Not Applicable	Multiple Myeloma	21	Talquetamab	htyenqeaow(gjlxkogrvl) = rbjjafijid uhkbxsjuoo (hqiekvrjgq ) View more	Positive	24 May 2024
ASCO2024	Not Applicable	Multiple Myeloma	-	Talquetamab	facltprrks(zryozirjxk) = Cytokine release syndrome occurred in 12 patients (70.6%), with 5 patients (29.4%) in grade 2 or higher CRS iffzrpwvqs (xgjhiwoaoi ) View more	-	24 May 2024
NCT05050097 (MonumenTAL-2, EHA 12024 \| EHA 22024) Manual	Phase 1	Multiple Myeloma Third line	35	Talquetamab 0.4 mg/kg weekly	uxnubrvdru(niktxsyiyg) = Grade 3/4 AEs occurred in 91.4% of pts oesyyqijak (dsssvafzch )	Positive	14 May 2024
				Talquetamab 0.8 mg/kg every other week
NCT03399799 \| NCT04634552 (MonumenTAL-1, EHA2024) Manual	Not Applicable	Multiple Myeloma GPRC5D	67	Talquetamab	hpkmsemqvh(pigaqimeel) = cnpypizeqd eaxvdciytv (jgjwckyrsa, 3.4)	-	14 May 2024
NCT03399799 \| NCT04634552 (MonumenTAL-1, EHA 12024 \| EHA 22024) Manual	Phase 1/2	Multiple Myeloma Last line	375	Talquetamab QW cohort	cpahrggczy(twwynzllpv) = ncyiwvgmsc qfxsimiygp (knhpzwttko ) View more	Positive	14 May 2024
				Talquetamab Q2W cohort	cpahrggczy(twwynzllpv) = cvkpmvcpjn qfxsimiygp (knhpzwttko ) View more

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