AbbVie Announces Positive Topline Results from the Phase 3 CERVINO Trial Showing Etentamig Significantly Improved Response Rate and Progression-Free Survival in Patients with Relapsed/Refractory Multiple Myeloma
Phase 3 CERVINO data suggest etentamig may offer superior efficacy with manageable safety and convenient monthly dosing in heavily pre-treated myeloma.
Rhea-AI Summary
AbbVie (ABBV) reported positive topline Phase 3 CERVINO results showing investigational BCMA x CD3 bispecific etentamig improved objective response rate and progression-free survival versus standard available therapies in triple-class exposed relapsed/refractory multiple myeloma.
Among 393 patients with a median of three prior treatment lines and 11.4 months median follow-up, etentamig achieved a significantly higher ORR of 74.0% versus 45.7% with investigator’s choice therapies and improved PFS with a hazard ratio of 0.40, with benefit seen across all pre-specified subgroups. Twelve‑month overall survival was 87.9% with etentamig versus 72.0% with standard therapies (HR 0.48), although the prespecified OS efficacy boundary was not crossed. Safety with a single step-up dose and monthly dosing showed low, mostly grade 1 cytokine release syndrome (28.3% CRS, no grade ≥3) and low treatment-emergent adverse event discontinuations (3.6% vs 9.6%). The Independent Data Monitoring Committee recommended unblinding based on the significant benefit, and AbbVie plans discussions with global regulators.
Positive
- Objective response rate 74.0% with etentamig vs 45.7% with standard therapies at 11.4 months median follow-up
- Progression-free survival hazard ratio 0.40 vs standard available therapies, with benefit across all pre-specified subgroups
- 12-month overall survival 87.9% with etentamig vs 72.0% with standard therapies (HR 0.48; nominal P=0.0012)
- Low cytokine release syndrome incidence 28.3%, predominantly grade 1 (23.9%), with no grade 3 or higher CRS events
- Treatment-emergent AE discontinuations lower with etentamig: 3.6% vs 9.6% for standard therapies
- IDMC recommended unblinding at first planned efficacy interim analysis due to significant benefit
Negative
- Grade 3/4 infections higher with etentamig: 27.7% vs 19.2% with standard therapies
- Overall survival boundary for prespecified efficacy was not crossed at data cutoff despite favorable 12‑month OS trend
- Regulatory status: etentamig remains investigational and is not yet approved by global authorities
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- Etentamig, an investigational asset, achieved a significantly improved objective response rate (ORR,
74% ) and a60% risk reduction in disease progression or death (progression-free survival, hazard ratio 0.40) versus investigator's choice of standard available therapies - Etentamig demonstrated low rates of cytokine release syndrome (CRS) and fatal infections with monthly dosing (Q4W) from initiation following a single step-up dose
- Etentamig's dosing schedule and clinical profile may offer a differentiated treatment option for patients and providers
- Results support the potential of etentamig, a second-generation BCMA-directed T-cell engager, to enable treatment across a range of settings, including outpatient and community-based care
At the data cutoff, the Phase 3 CERVINO trial included 393 patients who had received a median of three prior lines of therapy. At the median follow-up of 11.4 months, etentamig demonstrated statistically significant and clinically meaningful efficacy with a manageable safety profile:
- Significantly higher ORR with etentamig vs. SAT (
74.0% [95% CI, 67.25–79.97] vs.45.7% [95% CI, 38.59–52.91]; P<0.0001).2 - Significantly improved PFS with etentamig vs. SAT (HR, 0.40;
95% CI, 0.29–0.54; P<0.0001). The PFS benefit was observed across all pre-specified subgroups evaluated.2 - 12-month overall survival (OS) was
87.9% for etentamig vs.72.0% for SAT (HR, 0.48;95% CI: 0.29–0.77; nominal P=0.0012); prespecified efficacy boundary for OS was not crossed at data cutoff.2 - With a single step-up dose (SUD) and monthly (Q4W) dosing from initiation, etentamig demonstrated a potentially differentiated safety profile. Grade 3/4 infections occurred in
27.7% and19.2% of patients receiving etentamig and SAT, respectively. Fewer grade 5 infections occurred with etentamig (1.5% ) vs. SAT (3.1% ). Among patients receiving a single step-up dose, the incidence of cytokine release syndrome (CRS) was low (28.3% ) and predominantly grade 1 (23.9% ) with no grade 3 or higher events reported. One patient experienced immune effector cell-associated neurotoxicity syndrome (ICANS) (0.9% , grade 1) with no grade 2 or higher events reported. Discontinuations related to treatment-emergent adverse events were low for etentamig vs. SAT (3.6% vs.9.6% ).2
This was the first planned efficacy interim analysis of the CERVINO study and, based on the significant benefit, the Independent Data Monitoring Committee (IDMC) recommended unblinding the study.
"In this heavily pre-treated, triple-class exposed patient population, etentamig delivered clinically meaningful improvements in progression-free survival and response rates, alongside a manageable safety profile characterized by predominantly low-grade cytokine release syndrome," said Dr. Peter Voorhees, Chief, Plasma Cell Disorders Division at Atrium Health Levine Cancer Institute and an investigator on the CERVINO study. "Together, with its administration and dosing schedule, these findings support etentamig's role as a BCMA-targeted bispecific treatment option for multiple myeloma patients, with the potential to provide access across a range of treatment settings beyond specialized treatment centers and into outpatient and community-based settings."
While BCMA-directed bispecific antibodies and CAR-T therapies have transformed multiple myeloma treatment, their adoption remains limited by adverse events such as CRS, neurotoxicity and infections, as well as the need for specialized monitoring and treatment infrastructure.3,4,5 These may limit access for many patients, particularly in community settings. As the disease relapses and available treatment options become increasingly limited, there remains a critical unmet need for additional therapy options across a range of treatment settings.3,4,5
"The Phase 3 CERVINO results support the scientific approach behind etentamig and demonstrate the value of designing therapies that address both the biology of multiple myeloma and the practical needs of patients and providers through a manageable safety profile, a convenient dosing schedule and the potential for treatment in outpatient and community-based care settings," said Daejin Abidoye, M.D., vice president and therapeutic area head, oncology, solid tumor and hematology, AbbVie. "These results underscore our confidence in etentamig and our broader multiple myeloma strategy, which explores complementary T-cell engagers, targeted small molecules and rational combinations designed to address distinct disease mechanisms and patient needs over time."
AbbVie plans to discuss the Phase 3 CERVINO results with global regulatory authorities to determine next steps for etentamig.
IMS Presentation Details:
Abstract Title | Date/Time | Session |
CERVINO: Phase 3 Results of Etentamig | Friday, September | PLENARY SESSION |
Etentamig is an investigational asset and has not been approved for use by global regulatory authorities.
About the CERVINO Study1
CERVINO (NCT06158841) is a global, Phase 3, multicenter, randomized, open-label study evaluating etentamig versus investigator's choice of standard available therapies (SAT) in patients with relapsed/refractory multiple myeloma (RRMM) who have received at least two prior lines of therapy, including exposure to a proteasome inhibitor, an immunomodulatory drug and an anti-CD38 monoclonal antibody. Patients were randomized 1:1 to receive etentamig administered once every four weeks (Q4W) or SAT, including carfilzomib plus dexamethasone, elotuzumab plus pomalidomide and dexamethasone, or selinexor plus bortezomib and dexamethasone. Etentamig was administered using an optimized dosing strategy that incorporates a single step-up dose followed by monthly (Q4W) dosing from initiation.
The dual primary endpoints of CERVINO are overall response rate (ORR) and progression-free survival (PFS). Key secondary endpoints include overall survival (OS), depth of response, measurable residual disease (MRD) negativity, disease symptoms and physical functioning.
About Etentamig
Etentamig is an investigational, second-generation BCMA x CD3 bispecific antibody T-cell engager designed to combine meaningful anti-myeloma activity with a differentiated treatment experience for patients. Etentamig is composed of a low-affinity CD3 binding domain, designed to reduce cytokine release syndrome (CRS) and infections, a high-avidity bivalent BCMA-binding domain, and retained FcRn binding enabling monthly (Q4W) dosing after a single step-up dose. Clinical correlations of these structure-activity relationships have not been fully established.6
BCMA is highly expressed on the surface of malignant plasma cells in multiple myeloma, making it an ideal target for therapy. BCMA plays a crucial role in the survival of myeloma cells by promoting their growth and inhibiting their apoptosis (programmed cell death).5
Several clinical studies are evaluating the potential of etentamig across diverse patient populations and treatment settings. To learn more about AbbVie's ongoing etentamig clinical trials, please visit clinicaltrials.gov.
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, neuroscience and oncology – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X 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 antibodies 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 http://www.abbvie.com/oncology.
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 2025 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:
- AbbVie. Data on file ABVRRTI83865.
- Voorhees P, Manteca V, Costa L, et al. "CERVINO: Phase 3 Results of Etentamig vs. Investigator's Choice of Standard Available Therapies in Triple-Class Exposed Relapsed or Refractory Multiple Myeloma (RRMM)." Abstract presented at International Myeloma Society Annual Meeting, 2026. Glasgow, Scotland.
- Hej-Ali S, Banwell K, Mohamed H, et al. Toxicities of CAR-T, bispecific antibodies, and antibody-drug conjugates in multiple myeloma: a practical approach to risk mitigation and management. Cancers (Basel). 2026;18(13):2083. doi:10.3390/cancers18132083.
- Benda M, Reimann P, Willenbacher W, et al. Infectious toxicities associated with bispecific antibodies and CAR-T cells in multiple myeloma: a systematic review. Ann Hematol. Published online June 18, 2026. doi:10.1007/s00277-026-07140-8.
- Graham T, Ackbarali T, Patel K, Richter J. Integrating bispecific antibodies into community myeloma care: challenges, insights, and educational impact. Blood. 2025;146(suppl 1):8134. doi:10.1182/blood-2025-8134.
- D'Souza A, Shah N, Rodriguez C, et al. 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. J Clin Oncol. 2022;40(31):3576-3586. doi:10.1200/JCO.22.01504.
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