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

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

Start Date01 Dec 2026

Sponsor / Collaborator

Universitätsklinikum Hamburg-Eppendorf

[+2]

NCT07420959

/ Not yet recruitingPhase 1/2IIT

Phase 1/2 Trial of ABBV-383 for Patients With Relapsed Refractory Waldenström Macroglobulinemia

This phase I/II trial studies the side effects and best dose of ABBV-383 and to see how well it works in treating patients with Waldenström macroglobulinemia that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). ABBV-383 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).

Start Date25 Oct 2026

Sponsor / Collaborator

Mayo Clinic

NCT07095452

/ RecruitingPhase 2/3

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 Date08 Jan 2026

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

03 Dec 2025·Cureus Journal of Medical Science

Safety and Efficacy of Anti-B-cell Maturation Antigen (Anti-BCMA) Bispecific Antibodies for Relapsed/Refractory Multiple Myeloma: A Systematic Review of Clinical Trials

Review

Author: Jawed, Inshal ; Khan, Asad Ali ; Sajjad, Muhammad ; Rahman, Mansoor ; Khan, Muhammad Musa

Relapsed/refractory multiple myeloma (RRMM) remains a challenging condition with a need for more effective treatment options. There are ongoing clinical trials analyzing the effects of anti-B-cell maturation antigen (BCMA) bispecific antibodies (Abs) against RRMM with early, promising results. This study aims to systematically evaluate the safety and efficacy of anti-BCMA bispecific antibodies in patients with RRMM. PubMed, Embase, Web of Science, and the American Society of Hematology (ASH) website were searched for published evidence on the safety and efficacy of anti-BCMA bispecific Abs. Screening was performed using original clinical trials published in English, RRMM, and anti-BCMA-CD3 bispecific Abs as our inclusion criteria. Our search yielded a total of 2211 articles. After screening, we found 11 relevant clinical trials (five phase I, one phase I/II, two phase Ib, two phase II, one phase III). Across the trials, 910 patients with ages ranging from 32 to 82 years were analyzed. A majority of patients were exposed to and/or refractory to triple-class and penta-drugs (prior therapies ranged from 1 to 25). AMG-420, AMG-701, elranatamab, REGN5458, teclistamab (Tec), alnuctamab (ALNUC), and ABBV-383 are the seven anti-BCMA-CD3 bispecific Abs currently being assessed in clinical trials as monotherapy and in combination with immunomodulators/proteasome inhibitors against RRMM. Across the included trials, elranatamab demonstrated overall response rates (ORRs) of 61-64%, while teclistamab ranged from 40% to 78% depending on the regimen. ALNUC and ABBV-383 achieved ORRs of 51% and 57%, respectively. Among patients previously exposed to and/or refractory to anti-BCMA therapies (including antibody-drug conjugates and CAR-T cell therapy), ORRs were 54% for elranatamab and 40% for teclistamab. Incidence of cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) was low with subcutaneous (SC) administration of tec, elranatamab, and ALNUC. Across the studies, no death was reported due to CRS, although it led to treatment discontinuation in one patient in AMG-420, two patients in AMG-701, and dose reduction in three patients in ABBV-383 trials. Our analysis of the trials revealed that bispecific Abs showed efficacy in RRMM, with CRS and hematologic toxicities being the most common adverse events, mostly low-grade and manageable. Based on the promising efficacy and safety of BCMA targeting bispecific Abs, these drugs are emerging as a new therapeutic option for patients with advanced and RRMM.

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).

News (Medical) associated with Etentamig

08 Jun 2026

·www.biospace.com

AbbVie Presents New Data Across Its Blood Cancer Portfolio at EHA 2026

Data being presented, including six oral presentations, reinforce AbbVie's leadership and commitment to ongoing research to improve outcomes for people living with blood cancers NORTH CHICAGO, Ill. , June 8, 2026 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced it will share new data at the European Hematology Association (EHA) 2026 Congress and will showcase clinical advancements from research programs across multiple blood cancers, including multiple myeloma (MM), follicular lymphoma (FL), chronic lymphocytic leukemia (CLL), diffuse large B-cell lymphoma (DLBCL), acute myeloid leukemia (AML) and amyloidosis (AL). Featured data from AbbVie's blood cancer portfolio and pipeline include 21 oral and poster presentations, highlighting the investigational compound etentamig (ABBV-383), and approved therapies, EPKINLY ® (epcoritamab-bysp) (TEPKINLY ® in the EU), VENCLEXTA ® (venetoclax) (VENCLYXTO ® in the EU) and DECNUPAZ™ (pivekimab sunirine-pvzy). "The compelling data we are presenting at EHA reflect AbbVie's robust portfolio and pipeline and our ongoing work to advance the treatment and understanding of hematologic cancers," said Daejin Abidoye, M.D., vice president, therapeutic area head, oncology, solid tumor and hematology, AbbVie. "With this research, we continue our commitment to pioneering innovative solutions that have the potential to elevate standards of care for patients and help address the most pressing challenges in treating blood cancers." Key oral presentations of epcoritamab data include: Treatment impact of epcoritamab with lenalidomide and rituximab in relapsed or refractory (R/R) FL A subgroup analysis of the Phase 3 EPCORE FL-1 trial ( NCT05409066 ) of fixed-duration epcoritamab, in combination with rituximab plus lenalidomide (E+R 2 ) for patients with R/R FL (n=243), was performed to determine if the efficacy benefit and tolerability of E+R 2 extended across clinically relevant subgroups, including patients with higher- and lower-risk disease features, compared to R 2 . 1 Between Follicular Lymphoma International Prognostic Index (FLIPI) subgroups, overall response rate (ORR) was numerically higher with E+R 2 compared to R 2 (FLIPI 0–2, 96.5% vs 84.8%; FLIPI 3–5, 93.0% vs 72.6%). 1 A similar trend was seen in those with progression of disease less than or equal to two years from the date of initial frontline therapy (POD24). 1 Across the age subgroups, ORR and complete response rates (CRR) for E+R 2 and R 2 for ≥65 were (94.3% vs 80.2% and 80.7% vs 44.3%, respectively) and <65 (95.5% vs 78.4% and 83.9% vs 54.0%, respectively). Progression-free survival (PFS) hazard ratios (HRs) (95% CIs) for E+R 2 and R 2 for the NHL-5 low co-morbidity index score were (0.27 [0.17–0.42]) and NHL-5 high + intermediate were (0.14 [0.06–0.29]). 1 The E+R 2 safety pro all subgroups was consistent with the overall trial population, with no new safety signals. 1 Efficacy data of epcoritamab following systemic therapy in R/R large B-cell lymphoma ( LBCL) EPCORE DLBCL-1 ( EudraCT No. 2020-003016-27 ) is a randomized Phase 3 trial in R/R LBCL evaluating epcoritamab, a CD3×CD20 bispecific antibody, monotherapy. The study showed a statistically significant improvement in PFS versus investigator's choice of chemoimmunotherapy (CIT) — either rituximab plus gemcitabine plus oxaliplatin or bendamustine plus rituximab (HR 0.74 [95% CI, 0.60–0.92]; P=0.0059; 24-month PFS: 30% vs 13%). The study did not demonstrate a statistically significant improvement in overall survival (OS) (HR: 0.96 [95% CI, 0.77–1.20]). There was no OS detriment per pre-specified criteria.* 2 Epcoritamab reported a CRR of 38% and CIT 26%; (nominal P value 0.0032), duration of response (DOR) (median DOR 37 vs 6 months; duration of complete response (DOCR) NR vs 11 months, respectively) and time to next treatment (TTNT) (7 vs 4 months, respectively; nominal P value <0.0001). 2 Higher rates of grade 3–4 infections (30% vs 12%) and any-grade COVID-19 (36% vs 11%) were reported in the epcoritamab arm. Grade 5 treatment-emergent adverse events (TEAEs) occurred in 17% vs 6% (exposure-adjusted, 1.5 vs 1.8 per 100 pt-mo) and were largely attributable to grade 5 COVID-19 (9% vs 2%). 2 *OUS the protocol and SAP were amended to include dual primary endpoints of OS and PFS The following studies featuring venetoclax, etentamig and pivekimab sunirine-pvzy data will also be shared as oral and poster presentations: Predicted efficacy of venetoclax-based therapies in CLL based on genetic biomarkers Results from the Phase 3 GAIA/CLL13 ( NCT02950051 ) trial evaluating fixed-duration venetoclax-based combinations (with rituximab, obinutuzumab and obinutuzumab plus ibrutinib) as a chemotherapy-free alternative to chemoimmunotherapy (fludarabine, cyclophosphamide and rituximab or bendamustine and rituximab) in fit, previously untreated CLL patients lacking del(17p) or TP53 mutations. 3 Venetoclax in combination with rituximab and obinutuzumab plus ibrutinib in previously untreated CLL patients lacking del(17p) or TP53 mutations are investigational combinations not approved in the EU. Efficacy and safety data of venetoclax-obinutuzumab combination in previously untreated CLL Results from the open-label Phase 3 CLL14 trial ( NCT02242942 ) comparing the efficacy and safety of venetoclax in combination with obinutuzumab to obinutuzumab plus chlorambucil in previously untreated patients with CLL and coexisting medical conditions. 4 Real-world management practices with venetoclax-based therapy for AML Results from the prospective observational study, REVIVE ( NCT03987958 ), examining the effect of antimicrobial prophylaxis, post-remission administration of G-CSF and treatment initiation setting on safety and effectiveness outcomes with venetoclax plus hypomethylating agents (HMA) in newly diagnosed AML patients unfit for intensive chemotherapy. 5 Etentamig in patients with relapsed/refractory multiple myeloma (RRMM) with prior exposure to B-cell maturation antigen (BCMA)-targeted therapy Results from Arm B of the MONVISO study ( NCT05650632 ), evaluating a flat dose of etentamig in patients with RRMM with at least two prior lines of therapy, including triple-class and prior BCMA exposure. The Phase 1b study is assessing dose optimization and safety. 6 Etentamig is an investigational therapy not approved in the EU. Longer term safety and efficacy data of etentamig monotherapy in R/R light chain amyloidosis Updated results from M24-209 ( NCT06158854 ), evaluating etentamig monotherapy in BCMA-targeted therapy-naïve patients with relapsed/refractory immunoglobulin light chain amyloidosis. The open-label Phase 1/2 study is assessing dose escalation safety and efficacy. 7 Etentamig is an investigational therapy not approved in the EU. Efficacy data of pivekimab sunirine-pvzy in patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN) with baseline skin involvement in the CADENZA study Post-hoc analysis from CADENZA ( NCT03386513 ), evaluating the first-line use of pivekimab sunirine-pvzy in patients with BPDCN and varying degrees of skin involvement. The open-label Phase 1/2 study is assessing overall response rate, overall survival and percentage of eligible patients approved to proceed with a stem cell transplant. 8 Pivekimab sunirine-pvzy is an investigational therapy not approved in the EU. Details on key oral and poster presentations at the EHA 2026 Congress are available below and the full abstracts are available here . Oral Presentations: Title Date/Time Session Abstract/ Presentation Number Clinically Relevant Subgroup Analysis from the Randomized Phase 3 EPCORE FL-1 Trial: Treatment (Tx) Effect of Epcoritamab with Lenalidomide and Rituximab (R 2 ) in R/R Follicular Lymphoma (FL) Thursday, June 11, 17:45 - 18:00 CEST Oral Session, K1 Hall EHA-3041 Short: S229 Results from EPCORE DLBCL-1: Randomized Phase 3 Study of Epcoritamab (Epcor) Vs Investigator's Choice Chemoimmunotherapy (CIT) in Patients with Relapsed/Refractory Large B-Cell Lymphoma (R/R LBCL) Friday, June 12, 17:15 - 17:30 CEST Oral Session, Nobel Hall EHA-2409 Short: S235 Venetoclax-obinutuzumab for Previously Untreated Chronic Lymphocytic Leukemia: Final Results of the Randomized CLL14 Study Friday, June 12, 17:30 - 17:45 CEST Oral Session, AE1 Hall EHA-2488 Short: S146 Genetic Biomarkers Predicting Sustained Efficacy of Venetoclax-based Therapies or CIT in Chronic Lymphocytic Leukemia: Final 5-year Analysis of the GAIA/CLL13 Trial Friday, June 12, 18:15 - 18:30 CEST Oral Session, AE1 Hall EHA-4841 Short: S149 Phase 1 Dose Escalation Safety and Efficacy of Etentamig in Patients with Relapsed or Refractory Light Chain Amyloidosis Friday, June 12, 18:15 - 18:30 CEST Oral Session, Victoria Hall EHA-1134 Short: S209 Fixed Duration Venetoclax Plus Epcoritamab Shows Favorable Tolerability and High Response Rates with Early Molecular Responses in R/R CLL/SLL: Interim Analysis of the Randomized HOVON 165/AETHER Trial Sunday, June 14, 11:45 - 12:00 CEST Oral Session, A10-11 Hall EHA-3784 Short: S153 Poster Presentations: Sustained Remissions Beyond 4 Years with Epcoritamab Monotherapy: Long-term Follow-up Results from the Pivotal EPCORE NHL-1 Trial in Patients with Relapsed or Refractory Large B-cell Lymphoma Friday, June 12, 18:45 CEST Poster Session, Hall A EHA-2191 Short: PF977 Epcoritamab + R-mini-chop Results In 2-year Remissions and High MRD-negativity Rates in Elderly Patients with Newly Diagnosed DLBCL: Results from the EPCORE NHL-2 Trial Friday, June 12, 18:45 CEST Poster Session, Hall A EHA-2359 Short: PF1007 Reduced CD20 Expression and Intratumoral CD3+ T Cells Following Epcoritamab Treatment Are Associated with Progressive Disease in a Subset of Diffuse Large B-cell Lymphoma and Follicular Lymphoma Friday, June 12, 18:45 CEST Poster Session, Hall A EHA-2343 Short: PF1069 Pharmacodynamic Biomarkers Support the Clinical Benefit of Epcoritamab Plus Rituximab and Lenalidomide (R 2 ) In Patients with Relapsed/Refractory Follicular Lymphoma (R/R FL): Analyses from EPCORE FL-1 Friday, June 12, 18:45 CEST Poster Session, Hall A EHA-3123 Short: PF1081 Real-world Management Practices with Venetoclax-based Therapy For AML - Results from the Prospective REVIVE Study Friday, June 12, 18:45 CEST Poster Session, Hall A EHA-3291 Short: PF536 The Efficacy of Pivekimab Sunirine (PVEK) in Patients (PTS) with Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) with Baseline Skin Involvement in the CADENZA Study Friday, June 12, 18:45 CEST Poster Session, Hall A EHA-1950 Short: PF500 Anchored Matching-adjusted Indirect Comparison of Epcoritamab, Lenalidomide, and Rituximab Vs Tafasitamab, Lenalidomide, and Rituximab in Relapsed/Refractory Follicular Lymphoma: EPCORE FL-1 Vs Inmind Saturday, June 13, 18:45 CEST Poster Session, Hall A EHA-1124 Short: PS2035 Comparative Effectiveness of Epcoritamab, Lenalidomide, and Rituximab in EPCORE FL-1 Vs Real-world Chemoimmunotherapy in Relapsed/Refractory Follicular Lymphoma Saturday, June 13, 18:45 CEST Poster Session, Hall A EHA-3065 Short: PS2042 Comparative Analyses of Epcoritamab in Combination with Lenalidomide and Rituximab Vs Obinutuzumab and Bendamustine in Relapsed/Refractory Follicular Lymphoma Saturday, June 13, 18:45 CEST Poster Session, Hall A EHA-3140 Short: PS2052 Epcoritamab + Chemoimmunotherapy in Patients with Relapsed/Refractory Large B-cell Lymphoma Eligible for Autologous Stem Cell Transplant: Pooled Results from Arms 4 and 10 of EPCORE NHL-2 Saturday, June 13, 18:45 CEST Poster Session, Hall A EHA-2303 Short: PS2070 Fixed-duration Epcoritamab Monotherapy Induces High Response and MRD-negativity Rates in Elderly Patients with Newly Diagnosed Large B-cell Lymphoma and Comorbidities: Results from EPCORE DLBCL-3 Saturday, June 13, 18:45 CEST Poster Session, Hall A EHA-2346 Short: PS2082 Epcoritamab In Relapsed/Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL): Insights from the Real-world Epcoritamab Patient Characteristics and Outcomes Research (Real-epcor) Study Saturday, June 13, 18:45 CEST Poster Session, Hall A EHA-2202 Short: PS2086 Epcoritamab Plus Lenalidomide and Rituximab Improves or Preserves Health-related Quality of Life in Patients with Relapsed/Refractory Follicular Lymphoma Who Had High Symptom Burden or Adverse Events Saturday, June 13, 18:45 CEST Poster Session, Hall A EHA-2776 Short: PS2497 Quality of Life and Symptoms with Fixed-duration Acalabrutinib + Venetoclax ± Obinutuzumab Vs Chemoimmunotherapy in Treatment-naive Chronic Lymphocytic Leukemia: Patient-Reported Outcomes from AMPLIFY Saturday, June 13, 18:45 CEST Poster Session, Hall A EHA-4662 Short: PS1706 Etentamig In Patients (PTS) with Relapsed/Refractory Multiple Myeloma (RRMM) with Prior Exposure to B-cell Maturation Antigen (BCMA)-targeted Therapy Saturday, June 13, 18:45 CEST Poster Session, Hall A EHA-2799 Short: PS1913 Etentamig (ABBV-383) is an investigational medicine and is not approved by any health authorities worldwide. The safety and efficacy of this medicine is under evaluation as part of ongoing clinical studies. Pivekimab sunirine is not approved in the EU. EPKINLY ® /TEPKINLY ® (epcoritamab) and VENCLEXTA ® /VENCLYXTO ® (venetoclax) 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. Additional information on AbbVie clinical trials is available at . USE & IMPORTANT SAFETY INFORMATION for EPKINLY ® (epcoritamab-bysp) in U.S. What is EPKINLY? EPKINLY is a prescription medicine used to treat adults with: certain types of diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma that has come back (relapsed) or that did not respond (refractory) after 2 or more treatments. follicular lymphoma (FL) that has come back or that did not respond to previous treatment, together with lenalidomide and rituximab follicular lymphoma (FL) that has come back or that did not respond after 2 or more treatments. EPKINLY for the treatment of DLBCL is approved based on patient response data. Studies are ongoing to confirm the clinical benefit of EPKINLY. It is not known if EPKINLY is safe and effective in children. IMPORTANT SAFETY INFORMATION Important Warnings—EPKINLY can cause serious side effects, including: Cytokine release syndrome (CRS) , which is common during treatment with EPKINLY and can be serious or lead to death. To help reduce your risk of CRS, you will receive EPKINLY on a step-up dosing schedule (when you receive 2 or 3 smaller step-up doses of EPKINLY before your first full dose during your first cycle of treatment), and you may also receive other medicines before and for 3 days after receiving EPKINLY. If your dose of EPKINLY is delayed for any reason, you may need to repeat the step-up dosing schedule. Neurologic problems that can be serious, and can be life-threatening, and lead to death. Neurologic problems may happen days or weeks after you receive EPKINLY. People with DLBCL or high-grade B-cell lymphoma may be hospitalized after receiving their first full dose of EPKINLY on Day 15 of Cycle 1 due to the risk of CRS and neurologic problems. People with FL may be hospitalized after receiving their first full dose of EPKINLY on Day 22 of Cycle 1 due to the risk of CRS and neurologic problems. Tell your healthcare provider or get medical help right away if you develop a fever of 100.4°F (38°C) or higher; dizziness or lightheadedness; trouble breathing; chills; fast heartbeat; feeling anxious; headache; confusion; shaking (tremors); problems with balance and movement, such as trouble walking; trouble speaking or writing; confusion and disorientation; drowsiness, tiredness or lack of energy; muscle weakness; seizures; or memory loss. These may be symptoms of CRS or neurologic problems. If you have any symptoms that impair consciousness, do not drive or use heavy machinery or do other dangerous activities until your symptoms go away. EPKINLY can cause other serious side effects, including: Infections that may lead to death. Your healthcare provider will check you for signs and symptoms of infection before and during treatment and treat you as needed if you develop an infection. You should receive medicines from your healthcare provider before you start treatment to help prevent infection. Tell your healthcare provider right away if you develop any symptoms of infection during treatment, including fever of 100.4°F (38°C) or higher, cough, chest pain, tiredness, shortness of breath, painful rash, sore throat, pain during urination, feeling weak or generally unwell, or confusion. Low blood cell counts, which can be serious or severe. Your healthcare provider will check your blood cell counts during treatment. EPKINLY may cause low blood cell counts, including low white blood cells (neutropenia and lymphopenia), which can increase your risk for infection; low red blood cells (anemia), which can cause tiredness and shortness of breath; and low platelets (thrombocytopenia), which can cause bruising or bleeding problems. Your healthcare provider will monitor you for symptoms of CRS, neurologic problems, infections, and low blood cell counts during treatment with EPKINLY. Your healthcare provider may temporarily stop or completely stop treatment with EPKINLY if you develop certain side effects. Before you receive EPKINLY, tell your healthcare provider about all your medical conditions, including if you have an infection, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. If you receive EPKINLY while pregnant, it may harm your unborn baby. If you are a female who can become pregnant , your healthcare provider should do a pregnancy test before you start treatment with EPKINLY and you should use effective birth control (contraception) during treatment and for 4 months after your last dose of EPKINLY. Tell your healthcare provider if you become pregnant or think that you may be pregnant during treatment with EPKINLY. Do not breastfeed during treatment with EPKINLY and for 4 months after your last dose of EPKINLY. The most common side effects of EPKINLY when used alone in DLBCL or high-grade B-cell lymphoma or FL include CRS, injection site reactions, tiredness, muscle and bone pain, fever, diarrhea, COVID-19, rash, and stomach-area (abdominal) pain. The most common severe abnormal laboratory test results with EPKINLY when used alone include decreased white blood cells, decreased red blood cells, and decreased platelets. The most common side effects of EPKINLY when used together with lenalidomide and rituximab in FL include rash , upper respiratory tract infections, tiredness, injection site reactions, constipation, diarrhea, CRS, pneumonia, COVID-19, and fever. The most common severe abnormal laboratory test results with EPKINLY when used together with lenalidomide and rituximab include decreased white blood cells and decreased platelets. These are not all of the possible side effects of EPKINLY. Call your doctor for medical advice about side effects. You are encouraged to report side effects to the FDA at (800) FDA-1088 or or to Genmab US, Inc. at 1-855-4GENMAB (1-855-443-6622). Please see Full Prescribing Information and Medication Guide , including Important Warnings. Globally, prescribing information varies. Refer to the individual country product label for complete information. USE & IMPORTANT SAFETY INFORMATION for VENCLEXTA ® (venetoclax tablets) in U.S. Uses VENCLEXTA is a prescription medicine used: to treat adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). in combination with azacitidine, or decitabine, or low-dose cytarabine to treat adults with newly diagnosed acute myeloid leukemia (AML) who: ‒ are 75 years of age or older, or ‒ have other medical conditions that prevent the use of standard chemotherapy. It is not known if VENCLEXTA is safe and effective in children. Important Safety Information What is the most important information I should know about VENCLEXTA? VENCLEXTA can cause serious side effects, including: Tumor lysis syndrome (TLS). TLS is caused by the fast breakdown of cancer cells. TLS can cause kidney failure, the need for dialysis treatment, and may lead to death. Your healthcare provider will do tests to check your risk of getting TLS before you start taking VENCLEXTA. You will receive other medicines before starting and during treatment with VENCLEXTA to help reduce your risk of TLS. You may also need to receive intravenous (IV) fluids into your vein. Your healthcare provider will do blood tests to check for TLS when you first start and during treatment with VENCLEXTA. It is important to keep your appointments for blood tests. Tell your healthcare provider right away if you get any symptoms of TLS during treatment with VENCLEXTA, including fever, chills, nausea, vomiting, confusion, shortness of breath, seizures, irregular heartbeat, dark or cloudy urine, unusual tiredness, or muscle or joint pain. Drink plenty of water during treatment with VENCLEXTA to help reduce your risk of getting TLS. Drink 6 to 8 glasses (about 56 ounces total) of water each day, starting 2 days before your first dose, on the day of your first dose of VENCLEXTA, and each time your dose is increased. Your healthcare provider may delay, decrease your dose, or stop treatment with VENCLEXTA if you get symptoms of TLS. When restarting VENCLEXTA after stopping for 1 week or longer, your healthcare provider may check again for your risk of TLS and change your dose. Who should not take VENCLEXTA? Patients taking certain medicines during the beginning of VENCLEXTA (when the dose is being slowly increased) are at increased risk of TLS. Tell your healthcare provider about all the medicines you take, including prescription and over-the- counter medicines, vitamins, and herbal supplements. VENCLEXTA and other medicines may affect each other causing serious side effects. Do not start new medicines during treatment with VENCLEXTA without first talking with your healthcare provider. Before taking VENCLEXTA, tell your healthcare provider about all of your medical conditions, including if you: have kidney or liver problems. have problems with your body salts or electrolytes, such as potassium, phosphorus, or calcium. have a history of high uric acid levels in your blood or gout. are scheduled to receive a vaccine. You should not receive a "live vaccine" before, during, or after treatment with VENCLEXTA, until your healthcare provider tells you it is okay. If you are not sure about the type of immunization or vaccine, ask your healthcare provider. These vaccines may not be safe or may not work as well during treatment with VENCLEXTA. are pregnant or plan to become pregnant. VENCLEXTA may harm your unborn baby. Females who are able to become pregnant: ‒ Your healthcare provider should do a pregnancy test before you start treatment with VENCLEXTA. ‒ Use effective birth control during treatment and for 30 days after the last dose of VENCLEXTA. ‒ If you become pregnant or think you are pregnant, tell your healthcare provider right away. are breastfeeding or plan to breastfeed. It is not known if VENCLEXTA passes into your breast milk. Do not breastfeed during treatment with VENCLEXTA and for 1 week after the last dose. What should I avoid while taking VENCLEXTA? You should not drink grapefruit juice or eat grapefruit, Seville oranges (often used in marmalades), or starfruit during treatment with VENCLEXTA. These products may increase the amount of VENCLEXTA in your blood. What are the possible side effects of VENCLEXTA? VENCLEXTA can cause serious side effects, including: Low white blood cell counts (neutropenia). Your healthcare provider will do blood tests to check your blood count during treatment with VENCLEXTA and may pause dosing of VENCLEXTA or give you medicines to help treat your neutropenia if it is severe. Infections. Death and serious infections such as pneumonia and blood infection (sepsis) have happened during treatment with VENCLEXTA. Your healthcare provider will closely monitor and treat you right away if you get a fever or any signs of infection during treatment with VENCLEXTA. Tell your healthcare provider right away if you get a fever or any signs of an infection during treatment with VENCLEXTA. The most common side effects of VENCLEXTA when used in combination with acalabrutinib in people with CLL or SLL include low white blood cell count, headache, diarrhea, muscle and bone pain, and COVID-19. The most common side effects of VENCLEXTA when used in combination with obinutuzumab or rituximab or alone in people with CLL or SLL include low white blood cell count; low platelet count; low red blood cell count; diarrhea; nausea; upper respiratory tract infection; cough; muscle and joint pain; tiredness; and swelling of your arms, legs, hands, and feet. The most common side effects of VENCLEXTA in combination with azacitidine or decitabine or low-dose cytarabine in people with AML include nausea; diarrhea; low platelet count; constipation; low white blood cell count; fever with low white blood cell count; tiredness; vomiting; swelling of arms, legs, hands, or feet; fever; infection in lungs; shortness of breath; bleeding; low red blood cell count; rash; stomach (abdominal) pain; infection in your blood; muscle and joint pain; dizziness; cough; sore throat; and low blood pressure. Your healthcare provider may temporarily stop VENCLEXTA treatment, decrease your dose, or completely stop treatment if you get severe side effects. VENCLEXTA may cause fertility problems in males. This may affect your ability to father a child. Talk to your healthcare provider if you have concerns about fertility. These are not all the possible side effects of VENCLEXTA. Call your doctor for medical advice about side effects. You are encouraged to report side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. If you cannot afford your medication, contact genentech-access.com/patient/brands/venclexta for assistance. Please see full Prescribing Information . Globally, prescribing information varies. Refer to the individual country product label for complete information. U.S. Prescribing Information for AbbVie Medicines Please see full Prescribing Information including BOXED WARNING for DECNUPAZ (pivekimab sunirine-pvzy) 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 . 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 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 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. Contacts: Media: Anisha Bagchi Manix Email: anisha.manix@abbvie.com Investors: Liz Shea Email: liz.shea@abbvie.com _________________________________ 1 Tessoulin B, Nijland M, et al. Clinically Relevant Subgroup Analysis From The Randomized Phase 3 EPCORE FL-1 Trial: Treatment (Tx) Effect Of Epcoritamab With Lenalidomide And Rituximab (R²) In R/R Follicular Lymphoma (Fl). Abstract EHA-3041 presented at the European Hematology Association Congress 2026. Stockholm, Sweden. 2 Fox C, Inchiappa L, et al. Results From EPCORE DLBCL-1: Randomized Phase 3 Study Of Epcoritamab (Epcor) Vs Investigator's Choice Chemoimmunotherapy (Cit) In Patients With Relapsed/Refractory Large B-Cell Lymphoma (R/R Lbcl). Abstract EHA-2409 presented at the European Hematology Association Congress 2026. Stockholm, Sweden. 3 Tausch E, Schneider C, et al. Genetic Biomarkers Predicting Sustained Efficacy of Venetoclax-based Therapies or CIT in Chronic Lymphocytic Leukemia: Final 5-yr Analysis of the GAIA/CLL13 Trial. Abstract EHA-4841 presented at the European Hematology Association Congress 2026. Stockholm, Sweden. 4 Fischer K, Al-Sawaf O ,et al. Venetoclax-obinutuzumab for Previously Untreated Chronic Lymphocytic Leukemia: Final Results of the Randomized CLL14 Study. Abstract EHA-2488 presented at the European Hematology Association Congress 2026. Stockholm, Sweden. 5 Moshe Y, Wolach O, et al. Real-world Management Practices with Venetoclax-based Therapy For AML- Results from the Prospective REVIVE Study. Abstract EHA- 3291 presented at the European Hematology Association Congress 2026. Stockholm, Sweden. 6 Chhabra S, Searle E, et al. Etentamig In Patients with Relapsed/Refractory Multiple Myeloma (RRMM) with Prior Exposure to B-cell Maturation Antigen (BCMA)-targeted Therapy. Abstract EHA-2799 presented at the European Hematology Association Congress 2026. Stockholm, Sweden. 7 Kastritis E, Huart A, et al. Phase 1 Dose Escalation Safety and Efficacy of Etentamig in Patients with Relapsed or Refractory Light Chain Amyloidosis. Abstract EHA-1134 presented at the European Hematology Association Congress 2026. Stockholm, Sweden. 8 Pemmaraju N, Marconi G, et al. Efficacy of pivekimab sunirine-pvzy in patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN) with baseline skin involvement in the CADENZA study Abstract EHA-1950 presented at the European Hematology Association Congress 2026. Stockholm, Sweden. View original content: SOURCE AbbVie

Clinical ResultPhase 3Phase 1Drug ApprovalPhase 2

21 May 2026

·www.prnewswire.com

AbbVie Announces New Data at ASCO 2026 Demonstrating Breadth and Momentum Across its Next-Generation Oncology Pipeline

- Data from novel Top1i ADC and T-cell engager platforms highlight potential within solid tumors and blood cancers, including oral presentations in prostate cancer, small cell lung cancer, platinum-resistant ovarian cancer and multiple myeloma - NORTH CHICAGO, Ill., May 21, 2026 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that it will present new data at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago demonstrating the depth and breadth of its oncology pipeline. The data will be shared through multiple oral presentations and posters spanning solid tumors and blood cancer indications. Collectively, these presentations highlight AbbVie's continued focus on attacking cancer from inside and outside the cell, supported by sustained investment in its expanding antibody‑drug conjugate (ADC) platform, including Topoisomerase I inhibitor (Top1i)–based ADCs and its T‑cell engager (TCE) portfolio. "Our oncology pipeline is intentionally designed to address the complexity and heterogeneity of cancer biology through a diversified portfolio of differentiated therapies spanning multiple modalities," said Daejin Abidoye, M.D., vice president, therapeutic area head, oncology, solid tumor and hematology. "The data we are presenting at ASCO reflect the strength of this strategy, including continued momentum with our ADC programs in solid tumors and validation of immune-based approaches, such as etentamig, being investigated as a next-generation TCE in multiple myeloma. These results underscore our commitment to advancing assets with distinct scientific approaches aimed to address critical unmet patient needs." Key findings presented include: Data from AbbVie's Top1i ADCs Across Solid Tumors: Metastatic castration-resistant prostate cancer (mCRPC): A first-in-human Phase 1 study (NCT06318273) evaluating ABBV-969, a potential first-in-class bispecific ADC targeting PSMA/STEAP1, in heavily pretreated patients with mCRPC, demonstrated a confirmed objective response rate (ORR) of 45% among 29 patients with RECIST-evaluable disease. At active dose levels, 67% of patients achieved at least a 50% reduction in prostate-specific antigen (PSA50), with 28% achieving PSA90 responses. The safety profile was manageable in heavily pretreated patients with mCRPC.1 Additional findings to be presented at the meeting. Small cell lung cancer (SCLC): In Phase 1 data (NCT05599984) of ABBV-706 (SEZ6-directed ADC) in the monotherapy cohort (n=17), SCLC patients receiving ABBV-706 at the recommended Phase 3 dose of 1.8 mg/kg as a second-line therapy achieved an objective response rate (ORR) of 82%— promising data in a disease where prognosis remains poor. The safety profile was comparable with previously reported data.2 Additional findings and updated data will be presented at the meeting. The findings support continued evaluation of ABBV-706 in SCLC. Platinum-resistant ovarian cancer (PROC) and head and neck squamous cell carcinoma (HNSCC): Data from a Phase 1 basket study of Telisotuzumab adizutecan (Temab-A), a next-generation c-Met–directed ADC, demonstrated antitumor activity of Temab-A monotherapy in biomarker unselected PROC (NCT06084481) and HNSCC (NCT06084481) patients.3,4 Additional observations in c-Met selected patients, to be presented at the meeting, highlight the potential of Temab-A in this population.3,4 These new data support the potential of Temab-A across an expanding range of solid tumors and patient populations, including previously presented data in lung, colorectal and gastric cancers and across patients with MET-amplification and increased c-Met expression. Relapsed/refractory multiple myeloma (R/R MM): Data from a Phase 1b study of etentamig (NCT05650632), being investigated as a next-generation B-cell maturation antigen (BCMA) x CD3 T-cell engager, as monotherapy in a cohort of heavily pre-treated BCMA-exposed R/R MM patients will be presented at the meeting. Etentamig is an investigational BCMA and CD3 bispecific antibody T-cell engager composed of bivalent BCMA-binding domains allowing for high BCMA-avidity and a low-affinity CD3 binding domain. The data showed that among patients (n=11) that proceeded to etentamig after BCMA-directed CAR-T in the prior line of therapy, an ORR of 64% was achieved. Minimal residual disease (MRD) negativity was observed in 67% (2/3) of evaluable patients who received BCMA-directed therapy in the prior line of therapy. The median duration of response was 13 months. No new safety signals were observed. Despite no step-up dosing (SUD) in this cohort, all cytokine release syndrome (CRS) reported (57%) were grade 1 and 2.5 Additional findings to be presented at the meeting. Further information on AbbVie clinical trials is available at . Additional details on key presentations are available below, and the full ASCO Annual Meeting 2026 abstracts are available here . Telisotuzumab adizutecan (Temab-A), etentamig, ABBV-969, and ABBV-706 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. U.S. Prescribing Information for AbbVie Medicines Please see full Prescribing Information for ELAHERE™ (mirvetuximab soravtansine-gynx) Please see full Prescribing Information for EMRELIS™ (telisotuzumab vedotin-tllv) Please see full Prescribing Information for EPKINLY® (epcoritamab -bysp) 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 and neuroscience – 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 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 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: Dorff T, Peer A, Sharma M, et al. A phase 1, first-in-human (FIH) study evaluating the safety, pharmacokinetics, and efficacy of ABBV-969 in patients with metastatic castration-resistant prostate cancer (mCRPC). Abstract 5014presented at the American Society of Clinical Oncology Annual Meeting, 2026. Chicago, Illinois. Byers L, Cho B, Cooper A, et al. ABBV-706 as monotherapy and in combination with budigalimab in patients with relapsed/refractory (R/R) small cell lung cancer (SCLC). Abstract 8008 presented at the American Society of Clinical Oncology Annual Meeting, 2026. Chicago, Illinois. Fleming G, Kurnit K, Pelster M, et al. Phase 1 basket study of telisotuzumab adizutecan (Temab-A, ABBV-400), a c-Met protein-targeting antibody-drug conjugate: Results from patients with platinum-resistant ovarian/primary peritoneal/fallopian tube cancer (PROC). Abstract 5514 presented at the American Society of Clinical Oncology Annual Meeting, 2026. Chicago, Illinois. Villaflor V, Harding J, Mahadevan D, et al. Phase 1 basket study of telisotuzumab adizutecan (Temab-A, ABBV-400), a c-Met protein-targeting antibody-drug conjugate: Results from patients with head and neck squamous cell carcinoma (HNSCC). Abstract 6027 presented at the American Society of Clinical Oncology Annual Meeting, 2026. Chicago, Illinois. Chhabra S, Searle E, Popat R, et al. Etentamig in patients (pts) with relapsed/refractory multiple myeloma (RRMM) with prior exposure to B-cell maturation antigen (BCMA)-targeted therapy. Abstract 7508 presented at the American Society of Clinical Oncology Annual Meeting, 2026. Chicago, Illinois. SOURCE AbbVie 21% more press release views with Request a Demo

Clinical ResultASCOPhase 1ADC

01 May 2026

·allsci.com

AbbVie Q1’26 Earnings Call: Skyrizi combo doubles remission rates in refractory Crohn’s

During AbbVie’s Q1 2026 earnings conference call, held April 29, 2026, executives discussed the decision to accelerate Phase III development of the Skyrizi (risankizumab) plus ABBV-382 combination in inflammatory bowel disease after interim data showed double the endoscopic remission rate of either monotherapy in a highly refractory Crohn’s disease population. The company has also pulled forward its obesity Phase II program and signaled an earlier-than-expected regulatory submission for etentamig in multiple myeloma. Key Strategic Signals Skyrizi + ABBV-382 Combination: Interim data from AbbVie’s Crohn’s disease platform study showed the combination of Skyrizi (risankizumab) and ABBV-382, an anti-alpha 4 beta 7 antibody, achieved approximately 42% endoscopic remission at week 24 in a population where 82% had failed prior advanced therapies — double the rate observed with either monotherapy. Chief Scientific Officer Roopal Thakkar said the company observed a non-flat exposure-response relationship for ABBV-382, meaning patients with higher drug exposures fared better, and that a Phase IIb study initiating this summer will test a higher dose of ABBV-382 in combination with Skyrizi. AbbVie said it is simultaneously evaluating Phase III acceleration options and will evaluate Skyrizi in combination with ABBV-382 and separately with its extended half-life TL1A antibody, with ulcerative colitis (UC) included alongside Crohn’s disease. The Skyrizi plus lutikizumab cohort within the same platform study was discontinued after failing to differentiate meaningfully from Skyrizi monotherapy. Etentamig regulatory timeline advanced: AbbVie said it now expects to submit etentamig, its B-cell maturation antigen (BCMA) bispecific antibody, for regulatory review by the end of 2026 — earlier than previously guided. The Phase III monotherapy trial in third-line-plus multiple myeloma is tracking ahead of schedule, with a response rate readout anticipated in the third quarter of 2026 and the potential for a concurrent interim progression-free survival (PFS) analysis. If that interim PFS analysis is positive, AbbVie said regulatory submissions would follow in the same year. Thakkar also said plans are underway for a Phase III study evaluating etentamig in combination with pomalidomide in second-line-plus patients, including those previously exposed or refractory to anti-CD38 antibodies or who have lost response to a BCMA-directed CAR-T or antibody-drug conjugate (ADC). ABBV-295 obesity program accelerated: ABBV-295, a long-acting amylin analog with a half-life of approximately 270 hours, produced approximately 10% weight loss after 12 weeks in a multiple ascending dose study conducted predominantly in male, non-obese participants with a mean body mass index of approximately 29. AbbVie said the Phase II program has been pulled forward to the third quarter of 2026, with interim Phase I data in obese patients expected later this year. Thakkar noted the molecule signals through both amylin and calcitonin receptors, and said the pharmacodynamic profile supports potential monthly dosing in the maintenance setting, drawing an analogy to Skyrizi’s durable efficacy beyond its 28-day half-life. AbbVie also flagged active interest in external business development to complement ABBV-295 with additional obesity mechanisms, including oral agents and assets that preserve lean muscle mass. Analyst Pressure Points IBD combination positioning and competitive durability: JPMorgan analyst Christopher Schott pressed management on where the Skyrizi plus ABBV-382 combination fits in the treatment sequence — specifically whether it would be a second-line option post-Skyrizi or could reach the frontline. Thakkar said AbbVie does not intend to restrict the combination to refractory patients, noting that the platform study already enrolled patients who had previously received Skyrizi, vedolizumab, and Rinvoq (upadacitinib), and that frontline IBD use is commercially and clinically relevant given the risk of irreversible gut damage with uncontrolled inflammation. Schott also asked more broadly about AbbVie’s ability to sustain its immunology competitive position given increasing pipeline activity across the sector. Chief Executive Officer Robert Michael pointed to recent business development transactions — including Capstan Therapeutics for in vivo CAR-T B-cell depletion, Nimble Therapeutics for oral peptides, and additions of TL1A and IRAK4 mechanisms — as evidence that AbbVie is building depth beyond Skyrizi and Rinvoq for the next decade. RemeGen PD-1/VEGF bispecific differentiation: Deutsche Bank analyst James Shin pressed Thakkar on how RC-148, the PD-1/VEGF bispecific antibody acquired through the RemeGen agreement, can differentiate given its later entry into a field already occupied by established competitors. Thakkar said AbbVie’s strategy is not to develop RC-148 as a standalone asset but to deploy it as a combination partner for Temab-A, the company’s c-MET ADC, across colorectal, lung, and ovarian cancers — framing the asset’s value as contingent on ADC combinations rather than monotherapy positioning. Forward-Looking Catalysts Q3 2026 — etentamig Phase III response rate readout: The Phase III trial evaluating etentamig monotherapy in third-line-plus multiple myeloma is expected to deliver a response rate readout in the third quarter of 2026, with a potential concurrent interim PFS analysis. AbbVie said a positive interim PFS result would trigger regulatory submissions by year-end, making this the most time-sensitive oncology catalyst on the company’s near-term calendar. The trial’s ahead-of-schedule pace reduces execution risk on that timeline. H2 2027 readout for Temab-A colorectal cancer Phase III: Following AbbVie’s decision to pivot the next-generation c-Met directed ADC telisotuzumab adizutecan (Temab-A) colorectal cancer pivotal strategy from c-MET-selected monotherapy to an all-comers combination with bevacizumab, the company said it expects an initial data readout from the Phase III trial in the second half of 2027. The strategic rationale cited was a 30% objective response rate and 97% confirmed disease control rate for Temab-A plus bevacizumab versus 0% and 70%, respectively, for Lonsurf (trifluridine/tipiracil) plus bevacizumab as the comparator, with responses observed regardless of c-MET expression level. AbbVie also said Temab-A received its first breakthrough therapy designation as a monotherapy in second-line-plus EGFR wild-type non-squamous non-small cell lung cancer (NSCLC), with a Phase III trial in that setting in planning. This article was generated with AI assistance and reviewed and edited by the AllSci editorial team Explore more at AllSci News: https://allsci.com/news/ Your email address will not be published. Required fields are marked * Comment * Name * Email * Website

Phase 2Phase 3Clinical ResultBreakthrough TherapyPhase 1

100 Deals associated with Etentamig

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Refractory Multiple Myeloma	Phase 3	United States	AbbVie, Inc.	30 Nov 2026
Refractory Multiple Myeloma	Phase 3	Australia	AbbVie, Inc.	30 Nov 2026
Refractory Multiple Myeloma	Phase 3	Canada	AbbVie, Inc.	30 Nov 2026
Refractory Multiple Myeloma	Phase 3	France	AbbVie, Inc.	30 Nov 2026
Refractory Multiple Myeloma	Phase 3	Germany	AbbVie, Inc.	30 Nov 2026
Refractory Multiple Myeloma	Phase 3	Hungary	AbbVie, Inc.	30 Nov 2026
Refractory Multiple Myeloma	Phase 3	Italy	AbbVie, Inc.	30 Nov 2026
Refractory Multiple Myeloma	Phase 3	Netherlands	AbbVie, Inc.	30 Nov 2026
Refractory Multiple Myeloma	Phase 3	Norway	AbbVie, Inc.	30 Nov 2026
Refractory Multiple Myeloma	Phase 3	Portugal	AbbVie, Inc.	30 Nov 2026

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06158854 (M24-209, EHA2026)	Phase 1	Immunoglobulin Light-Chain Amyloidosis	34	Etentamig	wsnxdojcfo(fbcijqtyzv) = hblawrikke nfgovjgfel (grdykgqdbo ) View more	Positive	12 May 2026
NCT05259839 (ASH2025) Manual	Phase 1	Multiple Myeloma Third line	85	Etentamig + POM+DEX	pmhsmymbug(znwsnabgeq) = were neutropenia (78%), anemia (28%), and thrombocytopenia (22%). cvswdpeypn (jxivtxcunp ) View more	Positive	06 Dec 2025
NCT06158854 (M24109, ASH2025)	Phase 1/2	Immunoglobulin Light-Chain Amyloidosis	12	Etentamig	jauzqjcesy(wbznfescrj) = tfkymytjud uczkfsoosg (hrzqcdumvr ) View more	Positive	06 Dec 2025
NCT05650632 (ASH2025)	Phase 1	Relapse multiple myeloma	33	Etentamig (Relapsed/Refractory Multiple Myeloma)	mzmarmascb(ecewjadxjo) = no recurrent CRS events were observed beyond Cycle 1 mptoivvxvz (tgiqjlhnsh ) View more	Positive	06 Dec 2025
NCT03933735 (M22-466, ASH2025)	Phase 1	Refractory Multiple Myeloma	20	Etentamig	dkciovsspu(blliwbphlg) = sbjjltyjax nbbknlwvfl (kwlqujgqcv, 0.2)	Positive	06 Dec 2025
NCT03933735 (M22-466, ASH2025)	Phase 1	Refractory Multiple Myeloma	20	Etentamig (MRD-negative (<10-5))	dkciovsspu(blliwbphlg) = jtnimqjsth nbbknlwvfl (kwlqujgqcv, 0.2)	Positive	06 Dec 2025
NCT03933735 (Ph 1 studies, ASCO2025)	Phase 1	Relapse multiple myeloma BCMA \| CD3	146	Etentamig 60 mg Q4W	eqrfpxqxjc(zonriujbub) = 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 ofmasoonrj (rrwjrqixac ) View more	Positive	30 May 2025
NCT05650632 \| NCT03933735 (PF764, EHA2025)	Phase 1	Relapse multiple myeloma	146	Etentamig (Non-Black patients)	itemhzhyus(utfayavkji) = apkicyqdlu ltkuowypap (tpczapmmhb, 21% grade 1 and 5% grade 2) View more	Positive	14 May 2025
NCT05650632 \| NCT03933735 (PF764, EHA2025)	Phase 1	Relapse multiple myeloma	146	Etentamig (Black patients)	itemhzhyus(utfayavkji) = uugjnubuvo ltkuowypap (tpczapmmhb, all grade 1) View more	Positive	14 May 2025
NCT05650632 \| NCT03933735 (EHA2025)	Phase 1	Relapse multiple myeloma BCMA \| CD3	146	Etentamig 60 mg Q4W	eazakhykjx(eszxyvrqiw) = undvgcpcrb unvuitkeyi (tneeyfgzpb ) 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	owdtmizvbr(qwtynmtora) = 89% reduction of CD8+ T cells from periphery ruswgxkuqv (lzjulltawx ) View more	Positive	24 May 2024
NCT03933735 (ASCO2024)	Phase 1	Relapse multiple myeloma sBCMA \| IL-6 \| IL-8 ... View more	-	ABBV-383 40 mg Q3W		Positive	24 May 2024
NCT03933735 (ASCO2024)	Phase 1	Relapse multiple myeloma	220	ABBV-383 60mg Q4W	qwwhnwytxk(rmoificpar) = rlhommstit pdimylvlrd (wxblvxtkcr ) View more	Positive	24 May 2024
NCT03933735 (ASCO2024)	Phase 1	Relapse multiple myeloma	220	ABBV-383 40mg Q3W	qwwhnwytxk(rmoificpar) = pifsvuamwv pdimylvlrd (wxblvxtkcr ) View more	Positive	24 May 2024

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