Phase 2/3, Multicenter, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Etentamig and Daratumumab (Etentamig+D) Compared to Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Subjects With Newly Diagnosed Multiple Myeloma Not Eligible for Transplant

Multiple myeloma (MM) is a cancer of the blood's plasma cells. The cancer is typically found in the bones and bone marrow (the spongy tissue inside of the bones) and can cause bone pain, fractures, infections, weaker bones, and kidney failure. This is a study to determine the adverse events, change in disease activity, and pharmacokinetics of Etentamig in adult participants with MM.
Etentamig is an investigational drug being developed for the treatment of MM. This study is broken into 2 phases; phase 2 with 3 study arms and phase 3 with 2 study arms. Participants in phase 2 will receive 1 of 3 doses of etentamig in combination with daratumumab. Participants in phase 3 will receive etentamig at RP3D in combination with daratumumab, or daratumumab, lenalidomide, and dexamethasone (DRd). Around 660 adult participants with MM will be enrolled at approximately 155 sites worldwide
Participants in phase 2 will receive 1 of 3 doses of etentamig as intravenous (IV) infusions, combination with subcutaneous (SC) injections of daratumumab. Participants in phase 3 will receive RP3D doses of etentamig as IV infusions, combination with SC injections of daratumumab, or SC injections of daratumumab, capsules of lenalidomide, and tablet/ IV injections of dexamethasone (DRd). The study duration is approximately 16 years.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and questionnaires.

Start Date12 Nov 2025

Sponsor / Collaborator

AbbVie, Inc.

NCT06896916

/ RecruitingPhase 1

Phase 1/2 Study of Etentamig in Combination With a CELMoD Agent for the Treatment of Patients With Relapsed/Refractory Multiple Myeloma

Multiple myeloma (MM) is a plasma cell disease characterized by the growth of clonal plasma cells in the bone marrow. The purpose of this study is to assess the adverse events and change in disease activity of etentamig in combination with a cereblon E3 ligase modulatory drug (CELMoD) agent in adult participants with relapsed/refractory (R/R) multiple myeloma (MM). Adverse events and change in disease state will be assessed.
Etentamig is an investigational drug being developed for the treatment of R/R MM. Study doctors put the participants in groups called treatment arms. Multiple doses of etentamig in combination with iberdomide will be explored. Each treatment arm receives a different dose of etentamig and iberdomide to determine a tolerable dose. Approximately 135 adult participants with R/R MM will be enrolled in the study in approximately 50 sites worldwide.
In phase 1 participants will receive escalating intravenous (IV) etentamig in combination with oral iberdomide. In phase 2 participants will receive IV etentamig at one of two doses in combination with oral iberdomide, as part of the approximately 129 month study duration.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and and monitoring of side effects.

Start Date07 Aug 2025

Sponsor / Collaborator

AbbVie, Inc.

NCT06892522

/ RecruitingPhase 1/2

A Phase 1/2, Open-Label, Platform Study to Evaluate Safety and Efficacy of Etentamig Monotherapy or Etentamig Combinations in Subjects With Multiple Myeloma

Multiple myeloma (MM) is a cancer of the blood's plasma cells. The cancer is typically found in the bones and bone marrow (the spongy tissue inside of the bones) and can cause bone pain, fractures, infections, weaker bones, and kidney failure. Treatments are available, but MM can come back (relapsed) or may not get better (refractory) with treatment. This is a study to determine the safety, efficacy, and pharmacokinetics of Etentamig in adult participants with MM.
Etentamig is an investigational drug being developed for the treatment of MM. This study is broken into 4 substudies and each substudy consists of a dose escalation phase and dose expansion phase. Participants will receive escalating doses of etentamig alone or in combination with daratumumab and lenalidomide (DR), carfilzomib and dexamethasone (Kd) or lenalidomide (R). This will be followed by etentamig at the dose levels established during the escalation phases alone or in combination with DR, Kd, R. The participants can also receive daratumumab, lenalidomide and dexamethasone (DRd), R, or daratumumab, carfilzomib, and dexamethasone (DKd) as a comparator in the dose expansion phases. Around 440 adult participants with MM will be enrolled at approximately 50 sites worldwide
In all substudies, participants will receive escalating doses of etentamig as Intravenous (IV) infusions, alone or in combination with DR, R or Kd, followed by IV infusions of etentamig at the dose levels established during the escalation phases alone or in combination with IV and oral DRd, DKd, or R. The study duration is approximately 130 months.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and questionnaires.

Start Date30 Jun 2025

Sponsor / Collaborator

AbbVie, Inc.

100 Clinical Results associated with Etentamig

100 Translational Medicine associated with Etentamig

100 Patents (Medical) associated with Etentamig

Literatures (Medical) associated with Etentamig

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.

02 Nov 2022·Cancer discovery

ABBV-383 Demonstrates Tolerability and Efficacy in Relapsed/Refractory MM

Article

Abstract:

The T cell–engaging bispecific antibody ABBV-383 was well tolerated in relapsed/refractory multiple myeloma (RRMM).

01 Nov 2022·Journal of clinical oncology : official journal of the American Society of Clinical Oncology

A Phase I First-in-Human Study of ABBV-383, a B-Cell Maturation Antigen × CD3 Bispecific T-Cell Redirecting Antibody, in Patients With Relapsed/Refractory Multiple Myeloma

Article

Author: Kumar, Shaji ; Lee, Shane ; Bueno, Orlando F. ; Yue, Susan ; Rodriguez, Cesar ; Voorhees, Peter M. ; Vij, Ravi ; Freise, Kevin J. ; D'Souza, Anita ; Weisel, Katja ; Talati, Chetasi ; Polepally, Akshanth R. ; Jin, Ziyi ; Shah, Nina ; Buelow, Ben ; Pothacamury, Rajvineeth K. ; Ross, Jeremy A.

PURPOSE:

ABBV-383, a B-cell maturation antigen × CD3 T-cell engaging bispecific antibody, has demonstrated promising results in an ongoing first-in-human phase I study (ClinicalTrials.gov identifier: NCT03933735 ) in patients with relapsed/refractory multiple myeloma (RRMM). Herein, we report safety and efficacy outcomes of this phase I dose escalation/expansion study.

METHODS:

Patients with RRMM (≥ three prior lines including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody) were eligible. ABBV-383 was administered intravenously over 1-2 hours once every 3 weeks, without any step dosing. A 3 + 3 design with backfilling for dose escalation was used (intrapatient escalation to highest safe dose permitted) followed by initiation of dose expansion.

RESULTS:

As of January 8, 2022, 124 patients (dose escalation [0.025-120 mg], n = 73; dose expansion [60 mg], n = 51) have received ABBV-383; median age was 68 years (range, 35-92 years). The most common hematologic treatment-emergent adverse events (TEAEs) were neutropenia (all grades: 37%) and anemia (29%). The most common nonhematologic TEAEs were cytokine release syndrome (57%) and fatigue (30%). Seven deaths from TEAEs were reported with all considered unrelated to study drug by the investigator. For all efficacy-evaluable patients (n = 122; all doses), the objective response rate (ORR) was 57% and very good partial response (VGPR) or better (≥ VGPR) rate was 43%. In the 60 mg dose expansion cohort (n = 49), the ORR and ≥ VGPR rates were 59% and 39%, respectively; and in the ≥ 40 mg dose escalation plus dose expansion cohorts (n = 79) were 68% and 54%, respectively.

CONCLUSION:

ABBV-383 in patients with RRMM was well tolerated with an ORR of 68% at doses ≥ 40 mg. This novel therapy's promising preliminary antitumor activity in heavily pretreated patients warrants further clinical evaluation.

News (Medical) associated with Etentamig

27 May 2025

·www.prnewswire.com

AbbVie Features New Data Across Difficult-to-Treat Solid Tumors and Blood Cancers at ASCO 2025, Highlighting Breadth and Depth of its Oncology Portfolio

- Key oral presentations highlight new data from AbbVie's novel investigational antibody-drug conjugates (ADCs) including telisotuzumab adizutecan (ABBV-400, Temab-A) in advanced non-small cell lung cancer (NSCLC), ABBV-706 in high-grade neuroendocrine neoplasms (NENs) and pivekimab sunirine (PVEK) in blastic plasmacytoid dendritic cell neoplasm (BPDCN). NORTH CHICAGO, Ill., May 27, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that key data from its broad oncology portfolio will be showcased across multiple oral presentations and posters at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting (May 30 - June 3, 2025). These new data highlight significant progress in AbbVie's robust oncology pipeline, across a range of difficult-to-treat solid tumors and blood cancers. "The data we're presenting at this year's ASCO reflect the breadth and depth of our oncology pipeline and our unwavering commitment to research that could transform outcomes for patients facing cancer," said Roopal Thakkar, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "These presentations underscore our leadership in driving scientific innovation to address some of the most pressing unmet needs in oncology today by leveraging our innovative platforms such as ADCs." An oral presentation on investigational telisotuzumab adizutecan (ABBV-400, Temab-A), a next-generation, c-Met directed antibody-drug conjugate (ADC) with a novel topoisomerase 1 inhibitor (Top1i) payload, will showcase: Preliminary safety and efficacy results in 41 patients with pre-treated, advanced epidermal growth factor receptor (EGFR)-mutated non-squamous non-small cell lung cancer (NSCLC) from the dose expansion part of a Phase 1 study (NCT05029882).1 Patients received a median of 3 prior lines of therapies and 93% of patients had prior anti-EGFR treatment. The objective response rate (ORR) was 63%.1 High ORR was observed regardless of c-Met protein expression levels.1 At the time of data cut-off, 54% of responders experienced a ≥6 months duration of response (DoR).1 The most common any-grade TEAEs in ≥30% of patients were anemia (63%), nausea (61%), vomiting (37%), decreased appetite (34%), and neutropenia (34%).1 Additional data with 4 months follow-up will be presented at ASCO. Temab-A is also being evaluated in multiple ongoing clinical trials including a Phase 1/2 Study (NCT06772623) in first-line NSCLC without actionable genomic alterations in combination with budigalimab (AbbVie's investigational programmed cell death 1 inhibitor), a Phase 2 study (NCT06107413) in second-line metastatic colorectal cancer (CRC) in combination with fluorouracil, folinic acid and bevacizumab, and a Phase 3 study (NCT06614192) as monotherapy in patients with c-Met overexpressing refractory metastatic CRC. "The anti-tumor activity of Temab-A in patients with pre-treated, advanced EGFR-mutated non-squamous NSCLC is encouraging and supports further exploration of this novel ADC in this setting," said Ross Camidge, M.D., Ph.D, University of Colorado Cancer Center, United States and principal investigator of the trial. "Temab-A appears to have a manageable safety profile and continues to show promising clinical activity in advanced NSCLC, which is associated with poor prognosis." Additional oral presentations will highlight new safety and efficacy data for ABBV-706, a SEZ6-directed ADC with a Top1i payload, and pivekimab sunirine (PVEK), a novel ADC designed to target CD123: In a Phase 1 open-label study of ABBV-706 monotherapy, 64 patients with high-grade neuroendocrine neoplasms (NENs), a diverse group of rare and aggressive solid tumors, received ABBV-706 monotherapy IV at 1.3–3.5 mg/kg once every 3 weeks.2,3 The entire cohort had an ORR of 31.3%, and a median DoR of 5.6 months.2 The most common grade ≥3 TEAEs (cumulative across all dose levels), were anemia (45%), neutropenia (33%), and thrombocytopenia (21%).2 Additional data will be presented at ASCO. This ongoing study (NCT05599984) is evaluating ABBV-706 as monotherapy, or in combination with budigalimab, carboplatin, or cisplatin, in patients with advanced solid tumors expressing SEZ6, including small-cell lung cancer, NENs and high-grade Central Nervous System tumors. Results from the open-label, multicenter Phase 1b/2 CADENZA trial (NCT03386513) of PVEK monotherapy in patients with previously untreated or relapsed/refractory (R/R) blastic plasmacytoid dendritic cell neoplasm (BPDCN), a highly aggressive and rare type of blood cancer, demonstrated clinical benefit.4,5 The results show that among 33 untreated patients, the primary endpoint of composite complete response (CCR) rate, defined as CR + clinical CR (CR with minimal skin abnormality), was 70% (95% CI, 51.3-84.4) with a median duration of CCR of 9.8 months. ORR was 85%.4 In the 51 patients with R/R BPDCN, the CCR rate was 14% with a median duration of CCR of 9.2 months. ORR was 35%.4 Among all the 84 patients enrolled, the most common grade ≥3 TEAEs were peripheral edema (12%).4 TEAEs led to discontinuation in 9% and 7% of patients with first-line and R/R BPDCN, respectively. 4 Additional data will be presented at ASCO. PVEK is also being evaluated in a Phase 1/2 study (NCT04086264) in R/R and newly diagnosed acute myeloid leukemia. "Over the past few years, we've significantly expanded our ADC portfolio to investigate a broad range of solid tumors and blood cancers, reflecting our deep commitment to transforming cancer care through targeted therapies and biomarker driven approaches," said Daejin Abidoye, M.D., vice president, therapeutic area head of solid tumors, AbbVie. "These results highlight the potential of our investigational medicines to offer a meaningful clinical benefit in multiple difficult-to-treat cancers, where current treatment options are limited." Further information on AbbVie clinical trials is available at . Additional details on key presentations at ASCO are available below and the full ASCO Annual Meeting 2025 abstracts are available here. Telisotuzumab adizutecan, ABBV-706, pivekimab sunirine, etentamig, livmoniplimab, budigalimab, ABBV-291 and ABBV-969 are investigational medicines and are not approved by any health authorities worldwide. The safety and efficacy of these investigational medicines are under evaluation as part of ongoing clinical studies. Venetoclax, ibrutinib, epcoritamab, telisotuzumab vedotin are approved medicines being investigated for additional uses. Safety and efficacy have not been established for these unapproved additional uses. EPKINLY ®/TEPKINLY ® (epcoritamab) is being co-developed by Genmab and AbbVie as part of the companies' oncology collaboration. The companies share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization. VENCLEXTA®/VENCLYXTO® (venetoclax) is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S. IMBRUVICA® (ibrutinib) is jointly developed and commercialized by Pharmacyclics LLC, an AbbVie company and Janssen Biotech, Inc. U.S. Prescribing Information for AbbVie Medicines Please see full Prescribing Information for EMRELIS™ (telisotuzumab vedotin-tllv) Please see full Prescribing Information for EPKINLY® (epcoritamab-bysp) Please see full Prescribing Information for IMBRUVICA® (ibrutinib) Please see full Prescribing Information for VENCLEXTA® (venetoclax tablets) About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology, neuroscience and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on LinkedIn, Facebook, Instagram, X (formerly Twitter) and YouTube. About AbbVie in Oncology AbbVie is committed to elevating standards of care and bringing transformative therapies to patients worldwide living with difficult-to-treat cancers. We are advancing a dynamic pipeline of investigational therapies across a range of cancer types in both blood cancers and solid tumors. We are focusing on creating targeted medicines that either impede the reproduction of cancer cells or enable their elimination. We achieve this through various, targeted treatment modalities and biology interventions, including small molecule therapeutics, antibody-drug conjugates (ADCs), immuno-oncology-based therapeutics, multispecific antibody and novel CAR-T platforms. Our dedicated and experienced team joins forces with innovative partners to accelerate the delivery of potential breakthrough medicines. Today, our expansive oncology portfolio comprises approved and investigational treatments for a wide range of blood cancers and solid tumors. We are evaluating more than 35 investigational medicines in multiple clinical trials across some of the world's most widespread and debilitating cancers. As we work to have a remarkable impact on people's lives, we are committed to exploring solutions to help patients obtain access to our cancer medicines. For more information, please visit . Forward-Looking Statements Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2024 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. References: Camidge R, Raimbourg J, Lee Y-G, et al. Telisotuzumab Adizutecan (ABBV-400; Temab-A), a c-Met Protein-Targeting Antibody-Drug Conjugate, in Patients With Advanced EGFR Mutated Non-Squamous NSCLC: Results From a Phase 1 Study. Abstract 8512 presented at the American Society of Clinical Oncology Annual Meeting, 2025. Chicago, Illinois. Cooper A, Chandana S, Furqan M, et al. Safety and efficacy of ABBV-706, a seizure-related homolog protein (SEZ6)- targeting antibody-drug conjugate, in high-grade neuroendocrine neoplasms. Abstract 105 presented at the American Society of Clinical Oncology Annual Meeting, 2025. Chicago, Illinois. Sultana Q, Kar J, Verma A, et al. A Comprehensive Review on Neuroendocrine Neoplasms: Presentation, Pathophysiology and Management. J Clin Med. 2023 Aug 5;12(15):5138. doi: 10.3390/jcm12155138. Pemmaraju N, Marconi G, Montesinos P, et al. Efficacy and safety of pivekimab sunirine (PVEK) in patients (pts) with blastic plasmacytoid dendritic cell neoplasm (BPDCN) in the CADENZA study. Abstract 6502 presented at the American Society of Clinical Oncology Annual Meeting, 2025. Chicago, Illinois. Cazzato G, Capuzzolo M, Bellitti E, et al. Blastic Plasmocytoid Dendritic Cell Neoplasm (BPDCN): Clinical Features and Histopathology with a Therapeutic Overview. Hematol Rep 2023;15(4):696-706 doi: 10.3390/hematolrep15040070. Contacts: SOURCE AbbVie WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultASCOPhase 1ADCPhase 2

13 Jan 2025

·www.fiercebiotech.com

JPM25: AbbVie pens $1B deal for Simcere’s phase 1 T-cell engager

AbbVie’s head of hematology Mariana Cota Stirner, M.D., Ph.D., said the deal shows commitment to \"advancing innovative treatments for complex cancers like multiple myeloma.”\n T-cell engagers have been hot property in recent months, so it’s only right that one the biggest deals to kick off the J.P. Morgan Healthcare conference should see AbbVie expanding its interest in the tech.The Big Pharma is handing China’s Simcere Zaiming an undisclosed upfront payment with the potential of up to $1.05 billion in milestone payments for a phase 1-stage trispecific antibody. The candidate, dubbed SIM0500, targets GPRC5D, BCMA and CD3 and is already in phase 1 trials for multiple myeloma in the U.S. and China.It’s not AbbVie’s first foray into T-cell engager dealmaking—the pharma paid $65 million upfront in October to license EvolveImmune’s multispecific biologics for various targets in solid and hematologic malignancies. Even before that deal, AbbVie had been showing an interest in the modality, with then-CEO Richard Gonzalez telling analysts back in 2023 that the BCMA bispecific antibody T-cell engager ABBV-383 was driving the company’s “high level of interest” in the space.In this morning’s release, AbbVie’s head of hematology Mariana Cota Stirner, M.D., Ph.D., said the deal with Simcere Zaiming, a subsidiary of Simcere Pharmaceutical, showed that the U.S. pharma is “committed to advancing innovative treatments for complex cancers like multiple myeloma through our relentless R&D efforts and collaborations.”T-cell engagers are bispecific antibodies that bind to T cells and a molecule on a target cell, coercing the T cells to attack the target. The modality has been at the center of a string of biotech announcements in recent weeks, including Candid Therapeutics’ $925 million biobucks pact with WuXi Biologics, the launch of GSK-backed Ouro Medicines and the blockbuster hype surrounding Janux Therapeutics’ phase 1 prostate cancer asset.

Phase 1License out/inADCPROTACsImmunotherapy

13 Jan 2025

·endpts.com

AbbVie partners with Simcere Pharma unit to develop myeloma drug

AbbVie is teaming up with Simcere Zaiming to develop an investigational new drug candidate for multiple myeloma. The agreement, announced Monday, reflects a trend of licensing deals with pharma companies in China to collaborate on drug development. Simcere Zaiming, a subsidiary of Simcere Pharmaceutical Group, could get up to $1.1 billion in milestone payments under the option-to-license agreement, AbbVie said in a press release. The drug candidate SIM0500 is in Phase 1 and “has shown strong T cell cytotoxicity against multiple myeloma (MM) cells by leveraging a combination of various antitumor effects,” according to the release. Multiple myeloma is a type of cancer that forms in plasma cells. Mariana Cota Stirner, Abbvie’s vice president, therapeutic area head for hematology, said in the release that “AbbVie is committed to advancing innovative treatments for complex cancers like multiple myeloma through our relentless R&D efforts and collaborations.” AbbVie last June announced the start of a Phase 3 trial for ABBV-383, another investigational drug under evaluation for relapsed or refractory multiple myeloma.

License out/inPhase 1Phase 3

100 Deals associated with Etentamig

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Plasma Cell Leukemia	Phase 3	United States	AbbVie, Inc.	19 May 2024
Plasma Cell Leukemia	Phase 3	China	AbbVie, Inc.	19 May 2024
Plasma Cell Leukemia	Phase 3	Japan	AbbVie, Inc.	19 May 2024
Plasma Cell Leukemia	Phase 3	Australia	AbbVie, Inc.	19 May 2024
Plasma Cell Leukemia	Phase 3	Austria	AbbVie, Inc.	19 May 2024
Plasma Cell Leukemia	Phase 3	Belgium	AbbVie, Inc.	19 May 2024
Plasma Cell Leukemia	Phase 3	Canada	AbbVie, Inc.	19 May 2024
Plasma Cell Leukemia	Phase 3	Czechia	AbbVie, Inc.	19 May 2024
Plasma Cell Leukemia	Phase 3	Denmark	AbbVie, Inc.	19 May 2024
Plasma Cell Leukemia	Phase 3	France	AbbVie, Inc.	19 May 2024

Clinical Result

Indication

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03933735 (Ph 1 studies, ASCO2025)	Phase 1	Relapse multiple myeloma BCMA \| CD3	146	Etentamig 60 mg Q4W	vravzxidyv(fetzgzyawj) = CRS incidence was 30% (4% G2; No ≥G3 events) with median time to CRS onset of 22.3 (5.5-29.6) hours; and median time to CRS resolution of 20.7 (1.8-131.7) hours kkvskguhso (rtgkwqwdxl ) View more	Positive	30 May 2025
NCT05650632 \| NCT03933735 (PF764, EHA2025)	Phase 1	Relapse multiple myeloma	146	Etentamig (Non-Black patients)	oceduavasf(tbpfguwpfl) = nwsizdmubx vxogizxjld (hlzyzbxeai, 21% grade 1 and 5% grade 2) View more	Positive	14 May 2025
				Etentamig (Black patients)	oceduavasf(tbpfguwpfl) = oullvfopcj vxogizxjld (hlzyzbxeai, all grade 1) View more
EHA2025	Phase 1	Relapse multiple myeloma BCMA \| CD3	146	Etentamig 60 mg Q4W	cvlthltnta(fycrrdblnr) = ueaoeeeaiz eaydmdheig (hkuageeqdr ) View more	Positive	14 May 2025
NCT03933735 (ASCO2024)	Phase 1	Relapse multiple myeloma sBCMA \| IL-6 \| IL-8 ... View more	-	ABBV-383 20 mg Q3W	krinyxojtf(hygoprshzs) = 89% reduction of CD8+ T cells from periphery ylwqoftcoa (avhnfqjfki ) View more	Positive	24 May 2024
				ABBV-383 40 mg Q3W
NCT03933735 (ASCO2024)	Phase 1	Relapse multiple myeloma	220	ABBV-383 60mg Q4W	ktfqpzxdpz(ocqbkoqywu) = wttjyptzwg xrmykpeijc (auaroqcbgw ) View more	Positive	24 May 2024
				ABBV-383 40mg Q3W	ktfqpzxdpz(ocqbkoqywu) = erbgqgglpg xrmykpeijc (auaroqcbgw ) View more
NCT06158841 \| NCT03933735 (ASCO2024)	Phase 1	Relapse multiple myeloma BCMA- \| CD3	220	ABBV-383 20 mg Q3W	koeijmbegs(lhqmcnirox) = tzwhzqasef lsxspzkjxj (iajaofrhhm ) View more	Positive	24 May 2024
				ABBV-383 40 mg Q3W	koeijmbegs(lhqmcnirox) = elamyylznq lsxspzkjxj (iajaofrhhm ) View more
NCT03933735 (phase 1 trial, EHA2024)	Phase 1	Multiple Myeloma BCMA \| CD3	220	ABBV-383 60mg Q4W	afjsymtcyr(jartfbsybc) = vmymzqetob zvapcmyimf (hwpsluuwuc ) View more	Positive	14 May 2024
				ABBV-383 40mg Q3W	afjsymtcyr(jartfbsybc) = yjybwraacm zvapcmyimf (hwpsluuwuc ) View more
NCT03933735 (Phase 1 Study, ASH2023)	Phase 1	Relapse multiple myeloma	220	ABBV-383 20 mg	snwxywvotv(zdsetashjm) = ofbopoojfd jdymubyntd (ebfsizdkoz ) View more	-	10 Dec 2023
				ABBV-383 40 mg	snwxywvotv(zdsetashjm) = dvzpxinurb jdymubyntd (ebfsizdkoz ) View more
ASH2023	Not Applicable	Multiple Myeloma	1,926	BCMA-directed BsAbs	gkvaqlmmti(qhbxtjvaug) = awvmzpelkt yozviihnia (ikqyyjbmbu ) View more	-	09 Dec 2023
IMS2023	Phase 1	Relapse multiple myeloma BCMA-positive \| CD3	-	ABBV-383	ccfekelzjc(bnyiywevab) = anemia (29%) ggcvxtlvfx (dsuivkdflj ) View more	-	26 Sep 2023

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

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Regulation

Understand key drug designations in just a few clicks with Synapse.

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Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis