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

2026-05-21 18:46 ET - News Release

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

PR Newswire

- 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 https://www.clinicaltrials.gov/.

Additional details on key presentations are available below, and the full ASCO Annual Meeting 2026 abstracts are available here.


        
          
            Title                        Date/Time                            Session                Abstract
                                                                                                           Number



        Etentamig in patients (pts) with           Friday,                      Oral Presentation                            7508
relapsed/refractory multiple
myeloma (RRMM) with prior                           May 29
exposure to B-cell maturation
antigen (BCMA)-targeted therapy.                                                 Oral Abstract
                                                                        Session
                                                    5:09-5:21
                                           PM CDT

                                                                                 Hematologic

                                                                                 Malignancies-
                                                                        Plasma Cell

                                                                                 Dyscrasia



        Phase 1 basket study of                    Saturday,                    Rapid Oral                                   5514
telisotuzumab adizutecan                   May 30                       Abstract Session
(Temab-A, ABBV-400), a


        c-Met protein-targeting antibody-
drug conjugate: Results from                        8:42-8:48                    Gynecologic
patients with platinum-resistant           AM CDT                       Cancer
ovarian/primary
epithelial/fallopian tube cancer
(PROC).



        A phase 2 randomized study                 Saturday,                    Poster Board:                    TPS3688
comparing telisotuzumab                    May 30                       447a
adizutecan monotherapy with
standard of care in patients with
post-adjuvant circulating tumor
DNA-positive colorectal cancer.                     9:00 AM-                     Poster Session
                                           12:00 PM
                                           CDT

                                                                                 Gastrointestinal
                                                                        Cancer-Colorectal
                                                                        and Anal



        A Phase 2 study of telisotuzumab           Saturday,                    Poster Board:                    TPS3157
adizutecan (ABBV-400; Temab-A)             May 30                       293a
in patients with advanced solid
tumors harboring MET
amplification.
                                                    1:30-4:30                    Poster Session
                                           PM CDT


                                                                                 Developmental
                                                                        Therapeutics-
                                                                        Molecularly
                                                                        Targeted Agents
                                                                        and Tumor Biology



        Phase 1 basket study of                    Saturday,                    Poster Board:                                6027
telisotuzumab adizutecan (ABBV-            May 30                                                      484
400, Temab-A), a c-Met protein-
targeting antibody-drug
conjugate: Results from patients
with head and neck squamous                         1:30-4:30                    Poster Session
cell carcinoma (HNSCC).                    PM CDT


                                                                                 Head and Neck
                                                                        Cancer





        Telisotuzumab adizutecan                   Sunday,                      Poster Board:                    TPS8663
(Temab-A) plus osimertinib (osi)           May 31                       451a
as 1L treatment for
unresectable/metastatic NSCLC.

                                                    9:00 AM-                     Poster Session
                                           12:00 PM
                                           CDT

                                                                                 Lung Cancer-

                                                                                 Non-Small Cell
                                                                        Metastatic



        Impact of MET amplification                Sunday,                      Poster Board: 314                            8524
(amp) on telisotuzumab vedotin             May 31
(Teliso-V) efficacy and safety in
2L+ non-squamous (NSQ) EGFR
wild-type (WT) NSCLC with c-Met                                                  Poster Session
protein overexpression (OE).                        9:00 AM-
                                           12:00 PM
                                           CDT
                                                                                 Lung Cancer-

                                                                                 Non-Small Cell
                                                                        Metastatic



        AndroMETa-Lung-713: A phase                Sunday,                      Poster Board:                    TPS8661
2/3 study of telisotuzumab                 May 31                       450a
adizutecan (ABBV-400, Temab-A)
vs standard of care (SOC) in
patients with epidermal growth
factor receptor (EGFR)-mutated                      9:00 AM-                     Poster Session
non-small cell lung cancer                 12:00 PM
(NSCLC).                                   CDT

                                                                                 Lung Cancer-

                                                                                 Non-Small Cell
                                                                        Metastatic



        SEZanne: A phase 2 randomized,             Sunday,                      Poster Board:                    TPS8135
open-label, multicenter study to           May 31                       603a
evaluate the optimal dose, safety,
and efficacy of ABBV-706 in
combination with atezolizumab
(atezo) versus standard of care                     9:00 AM-                     Poster Session
(SOC) in patients (pts) with               12:00 PM
                                           CDT

        previously untreated extensive-
stage (ES) small cell lung cancer
                                                                                 Lung Cancer-Non-
(SCLC).                                                                 Small Cell Local-
                                                                        Regional/Small
                                                                        Cell/Other
                                                                        Thoracic Cancers



        A phase 1, first-in-human (FIH)            Sunday,                      Rapid Oral                                   5014
study evaluating the safety,                                            Abstract Session
pharmacokinetics, and efficacy of                   May 31
ABBV-969 in patients with
metastatic castration-resistant
prostate cancer (mCRPC).                                                         Genitourinary
                                                    4:42-4:48
                                           PM CDT                                Cancer-Prostate,
                                                                        Testicular,

                                                                                 and Penile



        A single-arm, phase 2 study of             Monday,                      Poster Board:                    TPS5633
neoadjuvant mirvetuximab                   June 1                       296b
soravtansine and carboplatin for
FRα-expressing advanced-stage
serous epithelial ovarian, fallopian
tube, or primary peritoneal cancer                  9:00 AM-                     Poster Session
(M25-231; NCT06890338; GOG-                12:00 PM
                                           CDT

        3115).
                                                                                 Gynecologic
                                                                        Cancer



        ABBV-706 as monotherapy and in             Monday,                      Oral Presentation                            8008
combination with budigalimab in
patients with relapsed/refractory                   June 1
(R/R) small cell lung cancer (SCLC).
                                                                                 Oral Abstract
                                                                        Session
                                                    3:39-3:51
                                           PM CDT


                                                                                 Lung Cancer-Non-
                                                                        Small Cell Local-
                                                                        Regional/Small
                                                                        Cell/Other
                                                                        Thoracic Cancers



        Phase 1, first-in-human (FIH)              Monday,                      Poster Board: 406                            2041
study evaluating safety and
efficacy of ABBV-706: Results                       June 1
from patients with high-grade
central nervous system (CNS)                                                     Poster Session
tumors.
                                                    1:30-4:30
                                           PM CDT
                                                                                 Central Nervous
                                                                        System Tumors



        A US-based, retrospective,                                 N/A          Publication Only                 e15526
observational study of biomarker
testing patterns across lines of
therapy in patients with
metastatic colorectal cancer.                                                    Gastrointestinal
                                                                        Cancer -
                                                                        Colorectal and
                                                                        Anal



        Timing of biomarker testing and                            N/A          Publication Only                 e17574
associated clinical outcomes in
ovarian cancer patients: A
retrospective study.
                                                                                 Gynecologic
                                                                        Cancer



        Real-world (RW) characteristics                            N/A          Publication Only                 e17606
and outcomes in platinum-
resistant ovarian cancer (PROC)
patients treated with
mirvetuximab soravtansine                                                        Gynecologic
(MIRV) monotherapy or single-                                           Cancer
agent chemotherapy (CTx).

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 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 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 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:

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 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.

 
            Contacts:





 Media:                               Investors:



 Sourojit (Jit) Bhowmick, Ph.D.       Liz Shea



 
            jit.bhowmick@abbvie.com            liz.shea@abbvie.com

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