[M25-632]A Phase 1 First-in-Human, Open-Label Study Evaluating the Safety, Pharmacokinetics, and Efficacy of ABBV-711 as a Monotherapy or in Combination with Budigalimab(ABBV-181) in Adult Subjects with Advanced Squamous Tumors

Start Date17 Dec 2025

Sponsor / Collaborator

AbbVie GK

NCT07241039

/ RecruitingPhase 1

A Phase 1 First-in-Human, Open-Label Study Evaluating the Safety, Pharmacokinetics, and Efficacy of ABBV-711 as a Monotherapy or in Combination With Budigalimab (ABBV-181) in Adult Subjects With Advanced Squamous Tumors

Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess safety, tolerability, pharmacokinetics and preliminary efficacy of ABBV-711 as a monotherapy and in combination with budigalimab (ABBV-181) in adults with advanced squamous tumors.
ABBV-711 is an investigational drug being developed for the treatment of solid tumors. There are multiple treatment arms in this study. Participants will either receive ABBV-711 as a single agent or in combination with budigalimab (another investigational drug) at different doses. Approximately 220 adult participants will be enrolled in the study across 40 sites worldwide.
In part 1, oral ABBV-711 tablets will be given in escalating doses alone to participants with squamous (sq) tumors. In part 2 oral ABBV-711 tablets will be given at a selected dose from part 1 to participants with squamous non-small cell lung cancer (sqNSCLC), or head and neck squamous cell carcinoma (HNSCC). In part 3, oral ABBV-711 tablets will be given in escalating doses in combination with intravenously (IV) infused budigalimab to participants with sq tumors. In part 4 oral ABBV-711 tablets will be given at a selected dose from part 3 in combination with IV infused budigalimab to participants with sqNSCLC, or HNSCC. The estimated duration of the study is up to approximately 5 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 and may require frequent questionnaire, medical assessments, blood tests, and scans.

Start Date20 Nov 2025

Sponsor / Collaborator

AbbVie, Inc.

NCT06772623

/ RecruitingPhase 1/2

An Open-label Multi-Cohort Phase 1b/2 Study to Evaluate the Safety, Efficacy, and Optimal Dose of Telisotuzumab Adizutecan in Combination With a PD-1 Immune Checkpoint Inhibitor in Advanced or Metastatic Non-Squamous NSCLC With No Prior Treatment for Advanced Disease and No Actionable Genomic Alterations

Non small cell lung carcinoma (NSCLC) is the most frequently occurring histologic subtype of lung cancer and is the leading cause of cancer-related deaths worldwide. The purpose of this study is to assess adverse events and change in disease activity when Telisotuzumab Adizutecan (ABBV-400) is given in combination with a programmed cell death receptor 1 (PD1) immune checkpoint inhibitor to adult participants to treat NSCLC.
Telisotuzumab Adizutecan (ABBV-400) and budigalimab are investigational drugs being developed for the treatment of NSCLC. This study will be divided into two stages, with the first stage treating participants with several doses of telisotuzumab adizutecan in combination with budigalimab within the dose escalation regimen until the dose reached is tolerable and expected to be efficacious. In Stage 2 there will be 3 treatment groups. Two groups will receive pembrolizumab with different optimized doses of telisotuzumab adizutecan (to allow for the best dose to be studied in the future). One group will receive the standard of care (SOC) - pembrolizumab, pemetrexed, and investigator's choice of carboplatin or cisplatin, followed by pembrolizumab and pemetrexed. Approximately 252 adult participants with NSCLC will be enrolled in the study in 132 sites worldwide.
In the dose escalation stage participants will be treated with increasing intravenous (IV) doses of Telisotuzumab Adizutecan in combination with budigalimab until the dose of Telisotuzumab Adizutecan reached is tolerable and expected to be efficacious. In the dose optimization stage participants will be receive IV optimized doses of Telisotuzumab Adizutecan in combination with IV pembrolizumab, or IV SOC - pembrolizumab, pemetrexed, and investigator's choice of carboplatin or cisplatin, followed by pembrolizumab and pemetrexed. The study will run for a duration of approximately 33 months.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.

Start Date06 Mar 2025

Sponsor / Collaborator

AbbVie, Inc.

100 Clinical Results associated with Budigalimab

100 Translational Medicine associated with Budigalimab

100 Patents (Medical) associated with Budigalimab

Literatures (Medical) associated with Budigalimab

01 Apr 2026·Journal for ImmunoTherapy of Cancer

Phase 1b study of ABBV-368, tilsotolimod, budigalimab, and nab-paclitaxel in patients with recurrent/metastatic head and neck squamous cell carcinoma

Article

Author: Blaney, Martha ; Ramathal, Cyril ; Le, Xiuning ; Ochsenreither, Sebastian ; Haderlein, Marlen ; Daste, Amaury ; Oliva, Marc ; Perets, Ruth ; McDevitt, Michael ; Patel, Maulik ; Le Tourneau, Christophe ; Hong, Jaehyung ; Popovtzer, Aron ; Sukari, Ammar ; Rosenberg, Ari J ; Makkouk, Amani

Background:

ABBV-368 is a humanized monoclonal antibody that targets the costimulatory receptor OX40. Here, we investigate a treatment strategy with ABBV-368 combined with the investigational toll-like receptor 9 agonist tilsotolimod, the programmed cell death 1 inhibitor budigalimab, and nab-paclitaxel in patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC). To our knowledge, this is the first clinical study in this setting to investigate chemotherapy combined with three immunotherapy agents, aiming to overcome failure of prior immune checkpoint inhibition and chemotherapy.

Methods:

This phase 1b, multicenter, open-label study ( NCT04196283 ) enrolled adult patients with R/M HNSCC into one of three treatment arms: ABBV-368 with tilsotolimod, ABBV-368 with tilsotolimod and nab-paclitaxel, or ABBV-368 with tilsotolimod, nab-paclitaxel, and budigalimab. Patients were treated in 28-day cycles. ABBV-368, nab-paclitaxel, and budigalimab were administered intravenously and tilsotolimod via intratumoral injection. Study objectives included safety, tolerability, pharmacokinetics, and preliminary antitumor activity. In addition, biomarker analyses were performed.

Results:

Overall, 30 patients were enrolled; 16 received ABBV-368 plus tilsotolimod, 7 ABBV-368 plus tilsotolimod and nab-paclitaxel, and 7 ABBV-368 plus tilsotolimod, nab-paclitaxel, and budigalimab. In total, 80% of patients experienced any-grade adverse events related to ABBV-368. ABBV-368 and tilsotolimod induced peripheral interferon-gamma pathway upregulation, Th1 cytokine production, and T-cell activation that was not negatively impacted by nab-paclitaxel. There were no responses in the ABBV-368 plus tilsotolimod arm; one partial response was demonstrated in both the ABBV-368 plus tilsotolimod and nab-paclitaxel, and ABBV-368 plus tilsotolimod, nab-paclitaxel, and budigalimab arms, corresponding to an overall response rate of 14.3%.

Conclusions:

The quadruple combination of ABBV-368, tilsotolimod, nab-paclitaxel, and budigalimab was well tolerated and demonstrated pharmacodynamic activity. Several patients had disease stabilization, but clinical responses were limited. Initial priming and T-cell immune activation were inadequate to overcome prior therapy resistance mechanisms including a hypothesized unfavorable tumor microenvironment. Future work investigating strategies to target this inhibitory tumor microenvironment with optimally scheduled immunotherapy combinations in selected patients and indications is urgently needed to improve patient outcomes.

Trial registration number:

NCT04196283 .

01 Jan 2026·Contemporary Clinical Trials

Analytical treatment interruption as a tool in the evaluation of immune-mediated interventions for long-term antiretroviral-free control of HIV-1 among people with HIV

Article

Author: Topp, Andrew ; Abunimeh, Manal ; Pires Dos Santos, Ana Gabriela ; Berry, Jeff ; Lalezari, Jacob P ; Dubé, Karine ; Gill, Sarah ; Routy, Jean-Pierre ; Sokhela, Simiso M ; Diaz, Ricardo Sobhie ; Cohen, Daniel ; Mothe, Beatriz ; Schwarze, Siegfried ; Lewin, Sharon R ; Krishnan, Preethi ; Sinclair, Gary I

BACKGROUND:

Immune-mediated interventions have the potential to induce long-term antiretroviral treatment (ART)-free viral suppression in people with HIV. However, in the absence of biomarkers of viral control, studies looking at immune interventions require a planned long-term analytical treatment interruption (ATI) that may bring risks to participants and challenges for data interpretation. Herein, we describe an ongoing, global, proof-of-concept, randomized, placebo-controlled, phase 2 clinical trial with a planned ATI and illustrate how those risks have been mitigated to safely evaluate the long-term durability of ART-free viral control.

METHODS:

The trial evaluates an immunologic combination of low-dose budigalimab and trosunilimab administered during ATI. Adults aged 18-70 with confirmed HIV-1 on stable ART with viremia below the limit of detection and CD4+ counts >500 cells/mL willing to undergo ATI are randomized to receive budigalimab, trosunilimab, both (at 2 different trosunilimab doses), or neither. The primary efficacy endpoint is the proportion of participants achieving viral control (HIV-1 RNA <1000 copies/mL) without restarting ART at week 24. The planned ATI duration (≤112 weeks) evaluates the durability of off-ART viral control, long-term safety, and biomarkers. Key ATI elements align with published consensus recommendations [1] while incorporating feedback from members of the global HIV community.

CONCLUSIONS:

By sharing this study design, we hope to inform on the lessons learned from operationalizing a global study evaluating durable ART-free viral control, including the critical role of engaging members of the HIV community during clinical trial design to ensure the success of an ATI-inclusive study.

01 Nov 2025·NATURE MEDICINE

Budigalimab, an anti-PD-1 inhibitor, for people living with HIV-1: a randomized, placebo-controlled phase 1b study

Article

Author: Felizarta, Franco ; Lalezari, Jacob P ; Ramgopal, Moti N ; Betman, Heide ; Alcaide, Maria L ; Pires Dos Santos, Ana Gabriela ; Zhou, Fei ; Vaidya, Tanaya R ; Krishnan, Preethi ; Dorr, Patrick ; Routy, Jean-Pierre ; Mostafa, Nael M

Abstract:

Chronic human immunodeficiency virus type 1 (HIV-1) disease results in immune exhaustion and dampened T cell responses, and programmed cell death 1 (PD-1) inhibitors offer a potential approach to enable viral control without antiretroviral therapy (ART) through reversal of these effects. Budigalimab is an investigational humanized anti–PD-1 monoclonal antibody. Multiple intravenous (IV) low doses of budigalimab (Stage 1: 2 mg n = 10, 10 mg n = 10, placebo n = 5, two doses every 4 weeks; Stage 2: 10 mg n = 11, placebo n = 5, four doses every 2 weeks (Q2W)) were assessed in people living with HIV (PLWH; n = 41) in a randomized, double-blind, multicenter, placebo-controlled phase 1 study with an analytical treatment interruption (ATI) to identify an efficacious regimen with a favorable safety profile in PLWH. The primary endpoints were safety, tolerability and pharmacokinetics. Demographics and baseline characteristics were balanced across treatment groups, except for sex, which was mostly male. All participants identified as cisgender. Budigalimab was well tolerated for up to 44 weeks, with 29 of 41 participants experiencing an adverse event (AE), including 2 participants who each experienced one grade 1 reversible immune-related AE (thyroiditis, hyperthyroidism). Three grade 3 AEs were reported by two participants and one serious AE by one participant; none were deemed related to treatment. IV budigalimab 10 mg Q2W resulted in a slight accumulation of drug in serum, with concentrations remaining above the estimated concentration required for near-complete (>95%) PD-1 receptor saturation on CD8 + T cells for ~10 weeks in peripheral blood. In an exploratory efficacy analysis of a 12-week ATI initiated with the first of four 10 mg Q2W doses, 6 of 11 participants experienced a delayed rebound with a relatively low viral peak and/or off-ART viral control (<200 copies ml −1 ) for ≥6 weeks during ATI, with 2 sustaining ART-free viral control to study end (204−252 days). The study achieved prespecified endpoints, supporting further evaluation of budigalimab in PLWH in a phase 2 study. ClinicalTrials.gov identifier: NCT04223804 .

News (Medical) associated with Budigalimab

21 Aug 2026

·www.prnewswire.com

AbbVie to Present New Data at WCLC 2026 Showcasing Innovation Across Lung Cancer Pipeline

Clinical data from AbbVie's ABBV-1480 (RC148) PD-1/VEGF bispecific antibody in the frontline non-small cell lung cancer (NSCLC) setting will be presented via an oral presentation Additionally, new data and updates from AbbVie's telisotuzumab adizutecan (Temab-A) and ABBV-706 programs across NSCLC and small cell lung cancer (SCLC) to be shared Research reflects AbbVie's strategy aimed at building a lung cancer pipeline spanning next-generation immunotherapies, targeted antibody-drug conjugates (ADCs) and the potential for novel combination approaches NORTH CHICAGO, Ill., Aug. 21, 2026 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced new data highlighting research programs across its lung cancer portfolio being presented at the 2026 World Conference on Lung Cancer (WCLC), including non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC). The presentations span clinical, translational and real-world data across next-generation immunotherapies and targeted antibody-drug conjugates (ADCs), designed to generate insights into treatment burden, patient experience and biomarker identification that may help inform future research. "Our strategy in lung cancer is focused on building a complementary pipeline that brings together next-generation immunotherapies and targeted antibody-drug conjugates with the potential to address different aspects of tumor biology," said Daejin Abidoye, M.D., vice president and therapeutic area head of oncology, solid tumor and hematology at AbbVie. "Exploring the PD-1/VEGF approach represented by ABBV-1480 and the c-Met targeting by Temab-A are important elements of that strategy and may provide a foundation for potential novel combinations as we work to develop more tailored treatment approaches for people living with lung cancer." Advancing Novel Therapies Across Various Modalities in NSCLC Multiple presentations across AbbVie's NSCLC portfolio will showcase new studies and data analyses spanning multiple treatment modalities, highlighting first-line treatment approaches, patient experience and biomarker-informed research. ABBV-1480 (RC148): AbbVie, in partnership with RemeGen, will present Phase 1b data evaluating the investigational PD-1/VEGF bispecific antibody, ABBV-1480, in combination with platinum-based chemotherapy as a potential first-line treatment for advanced NSCLC. At the 10 mg/kg dose, identified as the recommended Phase 3 dose for further development in combination regimens in both squamous and non-squamous NSCLC, the primary endpoint of objective response rate (ORR) was 90.0% in squamous NSCLC (n=27/30) and 75.9% (n=22/29) in non-squamous NSCLC. The most common treatment-related adverse events (TRAEs) were a decrease in white blood cells, neutrophil, platelet counts and anemia. No grade ≥3 hemorrhages with the 10 mg combinations were observed. This overall manageable safety profile supports ongoing Phase 3 development for this novel investigational asset.1 Telisotuzumab adizutecan (Temab-A), an investigational c-Met-directed ADC with a topoisomerase 1 inhibitor (Top1i) payload: Building on encouraging preliminary activity2 observed in heavily pretreated patients, AbbVie initiated a Phase 1b/2 M24-536 study (NCT06772623). The study is evaluating a platinum-free combination of Temab-A and a PD-1 inhibitor, as a potential first-line treatment for advanced non-squamous NSCLC. The study includes analyses of c-Met and PD-L1 expression to identify the patients most likely to benefit from treatment.3 Temab-A is also being studied in epidermal growth factor receptor (EGFR)-mutated NSCLC as monotherapy or in combination with osimertinib (NCT07155187). Clinical Data Showcasing the Potential of ABBV-706 in SCLC ABBV-706 is an investigational SEZ6-targeted ADC with a Top1i payload, being evaluated in SCLC. Presentations at WCLC include research that further characterizes the program and the potential role of SEZ6 in SCLC. As previously reported, ABBV-706 demonstrated an ORR of 82% in patients with relapsed/refractory SCLC post platinum-based chemotherapy (n=17).4 New safety analyses from 240 patients who received ABBV-706 monotherapy showed generally manageable hematologic and gastrointestinal toxicities, with the most common gastrointestinal events, including nausea (35.8%), vomiting (17.5%) and diarrhea (10.8%), being largely low grade and most requiring no dose adjustments.5 Grade ≥3 treatment-related pneumonitis or interstitial lung disease was reported in 1.7% of patients receiving ABBV-706 monotherapy.6 Hematologic toxicities, including anemia, neutropenia and thrombocytopenia, were among the most common TRAEs.5 Serious TRAEs occurred in 12.5% of patients. ABBV-706 is being evaluated as monotherapy in a Phase 3 study (NCT07365241) and in combination with atezolizumab in the Phase 2 study (NCT07155174), in SCLC. Real-world research demonstrated that SEZ6 is broadly expressed in 91% of SCLC patients overall and in more than 96% of patients with brain or liver metastases. These findings further support SEZ6 as a potential therapeutic target in SCLC and other SEZ6-expressing tumors. 7 Additional details on key presentations are available below, and the full WCLC 2026 abstracts are available online. For information about AbbVie's clinical trial efforts in lung cancer, please visit clinicaltrials.gov. Telisotuzumab adizutecan (Temab-A) 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. AbbVie holds exclusive rights from RemeGen to develop, manufacture, and commercialize ABBV-1480 outside of the Greater China territory. Emrelis™ (telisotuzumab vedotin-tllv) is an approved medicine being investigated for additional uses. Safety and efficacy have not been established for these unapproved additional uses. U.S. Prescribing Information for AbbVie Medicines Please see full Prescribing Information for EMRELIS™ (telisotuzumab vedotin-tllv). 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. References: Zhang L, Zhao Y, Fan Y, et al. RC148 (ABBV-1480, PD-1/VEGF bispecific antibody) plus chemotherapy in first-line locally advanced or metastatic non-small cell lung cancer. Abstract OA14.01.03. presented at the World Conference on Lung Cancer, 2026. Seoul, Republic of Korea. De Miguel M, Yamamoto N, Raimbourg J, et al. ABBV-400, a c-Met protein-targeting antibody-drug conjugate (ADC), in patients with advanced EGFR wild-type non-squamous non-small cell lung cancer: results from a phase I study. Ann Oncol. 2024;35(Suppl):S805-S806. Abstract 1257MO. Horinouchi H, Cuppens K, Camidge DR, et al. Telisotuzumab adizutecan and PD-1 inhibitor in untreated advanced non-squamous non-small cell lung cancer: a phase 1b/2 study. Abstract P2.374. presented at the World Conference on Lung Cancer, 2026. Seoul, Republic of Korea. Byers LA, Cho BC, Cooper AJ, et al. ABBV-706 as monotherapy and in combination with budigalimab in patients with relapsed/refractory (R/R) small cell lung cancer (SCLC). J Clin Oncol 44, 8008-8008 (2026). Chiang AC, Byers LA, Cooper AJ, et al. Hematologic and Gastrointestinal Toxicity of ABBV-706 in Advanced Solid Tumors: Safety Profile from the First-in-Human Study. Abstract P3.316. presented at the World Conference on Lung Cancer, 2026. Seoul, Republic of Korea. Paz-Ares L, Chandana S, Chiang AC, et al. Pneumonitis/Interstitial Lung Disease in the First-in-Human ABBV-706 Study: Incidence, Management, and Risk Factors. E-Poster EP13.32. presented at the World Conference on Lung Cancer, 2026. Seoul, Republic of Korea. Jahchan N, Calip GS, Guadamuz JS, et al. SEZ6 is expressed across major clinical and demographic groups of SCLC patients: evidence from a US clinicogenomic database. Abstract P3.340. presented at the World Conference on Lung Cancer, 2026. Seoul, Republic of Korea. SOURCE AbbVie 21% more press release views with Request a Demo

Clinical ResultPhase 1ADCImmunotherapyPhase 3

21 May 2026

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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

29 Oct 2025

·www.fiercebiotech.com

AbbVie halts development of Dragonfly cancer asset midflight

Alongside the AbbVie partnership, buzzy Dragonfly has also taken flight with Merck, Gilead and Bristol Myers Squibb.\n AbbVie has scrapped an asset from its ongoing collaboration with Dragonfly Therapeutics, a spokesperson for the Chicago pharma confirmed to Fierce Biotech.“We have terminated clinical activity around ABBV-303,” the spokesperson said, alluding to a phase 1 solid tumor trial of the natural killer (NK) cell engager. “However, our partnership with Dragonfly is still ongoing.”The study was terminated in light of “strategic considerations,\" according to its entry on the federal trial database clinicaltrials.gov. AbbVie and Dragonfly were testing ABBV-303 alone and in combination with AbbVie\'s anti-PD-1 antibody budigalimab (ABBV-181).Dragonfly did not respond to multiple requests for comment from Fierce. ABBV-303 was the first asset from the AbbVie-Dragonfly team-up to hit the clinic, triggering a milestone payment for Dragonfly in March 2024. The duo forged their pact in 2019 and expanded it in 2022 to include additional targets, with a focus on oncology and autoimmune diseases.AbbVie was studying the candidate in solid tumors expressing c-Met, the company spokesperson said, which is a receptor protein commonly found on the surface of tumor cells.“This termination does not impact our commitment to continue advancing c-Met targeted therapies,” the spokesperson added.Dragonfly’s pipeline is packed with Big Pharma collaborations and a clutch of wholly owned assets, the most advanced of which is DF1001, a HER2-targeting NK cell engager currently in a phase 1/2 trial for non-small cell lung cancer and metastatic breast cancer.Alongside the AbbVie partnership, buzzy Dragonfly has also taken flight with Merck, Gilead and Bristol Myers Squibb, with BMS also once dumping an asset back into Dragonfly’s pond.

License out/inPhase 1Clinical Trial TerminationPROTACsADC

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D11643	-	-	-

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Metastatic Non-Squamous Non-Small Cell Lung Carcinoma	Phase 3	United States	AbbVie, Inc.	10 Apr 2024
Metastatic Non-Squamous Non-Small Cell Lung Carcinoma	Phase 3	Japan	AbbVie, Inc.	10 Apr 2024
Metastatic Non-Squamous Non-Small Cell Lung Carcinoma	Phase 3	Australia	AbbVie, Inc.	10 Apr 2024
Metastatic Non-Squamous Non-Small Cell Lung Carcinoma	Phase 3	Belgium	AbbVie, Inc.	10 Apr 2024
Metastatic Non-Squamous Non-Small Cell Lung Carcinoma	Phase 3	Chile	AbbVie, Inc.	10 Apr 2024
Metastatic Non-Squamous Non-Small Cell Lung Carcinoma	Phase 3	France	AbbVie, Inc.	10 Apr 2024
Metastatic Non-Squamous Non-Small Cell Lung Carcinoma	Phase 3	Israel	AbbVie, Inc.	10 Apr 2024
Metastatic Non-Squamous Non-Small Cell Lung Carcinoma	Phase 3	Netherlands	AbbVie, Inc.	10 Apr 2024
Metastatic Non-Squamous Non-Small Cell Lung Carcinoma	Phase 3	Spain	AbbVie, Inc.	10 Apr 2024
Metastatic Non-Squamous Non-Small Cell Lung Carcinoma	Phase 3	Taiwan Province	AbbVie, Inc.	10 Apr 2024

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04196283 (Pubmed \| J Immunother Cancer)	Phase 1	Recurrent Squamous Cell Carcinoma of the Head and Neck	30	ABBV-368 plus tilsotolimod (Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma)	dzpwpjdhpu(suiixbvzkt) = powkvdvnrn qvlqvhxqsb (vmmzinxwzx )	Negative	01 Apr 2026
				ABBV-368 plus tilsotolimod and nab-paclitaxel (Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma)	mdftykyinq(nmqaaoawhw) = ewcrfvofbz dtgftfbytu (sbcsaoagan ) View more
NCT05599984 (WCLC2025 \| NEWS) Manual	Phase 1	Extensive stage Small Cell Lung Cancer	80	ABBV-706 1.8 mg/kg Q3WABBV-706 1.8 mg/kg Q3W	hzliqkhdwr(oclodabgyi) = vivrtmaufk nraxuxoljg (gidkdmczyw ) View more	Positive	07 Sep 2025
				ABBV-706 2.5 mg/kg Q3WABBV-706 2.5 mg/kg Q3W	hzliqkhdwr(oclodabgyi) = qmkkcorziu nraxuxoljg (gidkdmczyw ) View more
NCT03821935 (NCT03821935, Pubmed \| Front Oncol)	Phase 1	Advanced Malignant Solid Neoplasm GARP:TGF-ß1 complex	-	Livmoniplimab	ejxvfyjude(gxuqgrdein) = bmyazzfdii mcmxlmrlxe (yddzoidxyl )	Positive	29 Oct 2024
				Budigalimab	sivsdtcuyr(akedriztom) = lbiuesrkrr jevsvxlvcz (tnessovihu ) View more
NCT03821935 (ASCO2024)	Phase 1	Solid tumor \| Transitional Cell Carcinoma TGF-β1 \| GARP:TGF-β1 complex	200	Livmoniplimab 1500 mg + Budigalimab 500 mg	kzbmjemkuz(owrjxeemhn) = slfxlqqcwa uxavqgbpfu (vutthbvwxr, 12.9 - 39.5) View more	Positive	24 May 2024
NCT03821935 (ASCO_GU2024) Manual	Phase 1	Transitional Cell Carcinoma	48	Livmoniplimab + budigalimab	snlgqjyhiz(octsdhvedn) = tuqwgejfub rssamfvlyd (taxcrpapxa, 12.9 - 39.5) View more	Positive	25 Jan 2024
NCT03000257 (Pubmed \| J Immunother)	Phase 1	Advanced Malignant Solid Neoplasm	182	Budigalimab 250mg Q2W	fkledvhkxf(dnlfewgnfs) = cmyuacvmkt ujttkkznim (grdocubjdx )	Positive	17 Jan 2022
				Budigalimab 500mg Q4W	fkledvhkxf(dnlfewgnfs) = gdsvdtigvg ujttkkznim (grdocubjdx )
NCT03000257 (Pubmed \| Cancer Immunol Immunother)	Phase 1	Squamous Cell Carcinoma of Head and Neck \| Non-Small Cell Lung Cancer	81	Budigalimab 250 mg	fniktwczes(unrvwhzvsp) = njzbxxpxdc oapygceiig (bcrabfhpdq, 5.1 - 24.5)	-	03 Jul 2021
				Budigalimab 500 mg	fniktwczes(unrvwhzvsp) = clqejrinnu oapygceiig (bcrabfhpdq, 9.2 - 32.6)
NCT03000257 (M15-892, Pubmed) Manual	Phase 1	Small Cell Lung Cancer	31	rovalpituzumab tesirine+budigalimab	fdbjuijjmd(ppmiylvhzy) = dzumzqncex jvumcaeaxk (zejnqdgrac ) View more	Positive	01 Jan 2021
NCT03000257 (AACR2020)	Phase 1	HR-positive/HER2-low Solid Tumors	81	Budigalimab IV 250 mg every two weeks	mpaoawvqzi(yohpzumqpj) = zahymsqtdh entemnaaid (cbicfwjuzz )	-	15 Aug 2020
				Budigalimab IV 500 mg every four weeks	mpaoawvqzi(yohpzumqpj) = anveskxjql entemnaaid (cbicfwjuzz )
NCT03000257 (M15-891, SITC2018)	Phase 1	Advanced Malignant Solid Neoplasm	62	ABBV-181 1 mg/kg	ihwxuwifnd(ruyfafzpev) = pckathchxt yrayyihprs (ouraakltnm, 31 - 59) View more	Positive	06 Nov 2018
				ABBV-181 3 mg/kg	ihwxuwifnd(ruyfafzpev) = yfagptuzzx yrayyihprs (ouraakltnm, 31 - 59) View more

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