This phase II trial tests how well telisotuzumab vedotin and osimertinib works for the treatment of non small cell lung cancer that is growing, spreading, or getting worse (progressive) and for which no treatment is currently available (incurable). Telisotuzumab vedotin is a monoclonal antibody, called telisotuzumab, linked to a toxic agent, called vedotin. Telisotuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of tumor cells, known as c-Met receptors, and delivers vedotin to kill them. Osimertinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving telisotuzumab vedotin and osimertinib may be effective for treating progressive, incurable non small cell lung cancer.

Start Date19 Feb 2026

Sponsor / Collaborator

Jonsson Comprehensive Cancer Center

[+1]

NCT06568939

/ RecruitingPhase 2

A Phase 2, Open-Label, Randomized, Global Study of Three Telisotuzumab Vedotin Regimens in Subjects With Previously Treated c-Met Overexpressing, EGFR Wildtype, Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer

Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. Non-small cell lung cancer (NSCLC) is a solid tumor, a disease in which cancer cells form in the tissues of the lung. The purpose of this study is to assess how safe telisotuzumab vedotin is in adult participants with NSCLC. Change in disease activity and adverse events will be assessed.
Telisotuzumab vedotin is an investigational drug being developed for the treatment of NSCLC. Participants will be randomly assigned a treatment of telisotuzumab vedotin in 1 of 3 arms at an 1:1:1 ratio. Each group receives intravenous (IV) infusion of telisotuzumab vedotin at different doses. Approximately 150 adult participants with c-Met overexpressing NSCLC will be enrolled in the study at approximately 80 to 90 sites worldwide.
Participants will receive IV telisotuzumab vedotin at 1 of 3 dose regimens as part of a 3 year study duration.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Start Date20 Jan 2025

Sponsor / Collaborator

AbbVie, Inc.

NCT06093503

/ WithdrawnPhase 3

Phase 3, Open-Label, Randomized, Controlled, Global Study of Telisotuzumab Vedotin (ABBV-399) Combined With Osimertinib vs Platinum-Based Chemotherapy in Subjects With c-Met Overexpressing (OE) EGFR Mutant, Locally Advanced/Metastatic Non-Squamous NSCLC After a First Progression on Prior Third Generation EGFR TKi Treatment

Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. Non-small cell lung cancer (NSCLC) is a solid tumor, a disease in which cancer cells form in the tissues of the lung. The purpose of this study is to assess how telisotuzumab vedotin in combination with osimertinib affects the disease state compared to standard of care in adult participants with locally advanced/metastatic non-squamous NSCLC that has a mutation in the epidermal growth factor receptor (EGFR) gene and that overexpresses the c-Met protein. Change in disease activity will be assessed.
Telisotuzumab vedotin is an investigational drug being developed for the treatment of NSCLC that overexpresses the c-Met protein. Participants are randomly placed in one of the two groups to receive telisotuzumab vedotin and osimertinib or standard of care chemotherapy. Approximately 250 adult participants with locally advanced/metastatic non-squamous NSCLC that has a mutation in the EGFR gene and that overexpresses the c-Met protein will be enrolled in the study in approximately 180 sites worldwide.
Participants will receive intravenous telisotuzumab vedotin every 2 weeks in combination with oral osimertinib tablets daily or standard of care chemotherapy (carboplatin/pemetrexed or cisplatin/pemetrexed as prescribed by the physician). Overall duration of the study is estimated to be approximately 47 months.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Start Date31 May 2024

Sponsor / Collaborator

AbbVie, Inc.

100 Clinical Results associated with Telisotuzumab vedotin

100 Translational Medicine associated with Telisotuzumab vedotin

100 Patents (Medical) associated with Telisotuzumab vedotin

470

Literatures (Medical) associated with Telisotuzumab vedotin

01 Aug 2026·ESMO Open

Antibody–drug conjugates in selected solid tumours: a position statement update based on findings from the third workshop held by the ETOP IBCSG Partners Foundation

Article

Author: Fontana, E ; Van Cutsem, E ; Paz-Ares, L ; Argilés, G ; Powles, T ; Garon, E B ; Drago, J Z ; André, F ; Schmelzle, T ; Burgers, S ; Lopez-Rios, F ; Skynner, M J ; Passaro, A ; Stahel, R A ; Klümper, N ; Smit, E ; Smyth, E ; Loi, S ; Mountzios, G ; Reguart, N ; Azizi, A A ; Curigliano, G ; Remon, J ; Pistilli, B ; Peters, S ; Meyer, M-L ; Le Bescond, L ; Swanton, C ; Banerjee, S

The European Thoracic Oncology Platform (ETOP) International Breast Cancer Study Group (IBCSG) Partners Foundation initiated a series of workshops for experts to review current evidence and offer recommendations to guide future antibody-drug conjugate (ADC) research. Here, we summarise key findings from the third workshop, which included experts in various solid tumours, basic/translational research scientists and pharmaceutical industry representatives. Recent positive phase III trial data have further incorporated ADCs into the standard of care [e.g. lung: sacituzumab tirumotecan; breast: trastuzumab deruxtecan (T-DXd), sacituzumab govitecan, datopotamab deruxtecan; muscle-invasive bladder cancer: enfortumab vedotin; ovarian cancer: mirvetuximab soravastine; cervical cancer: tisotumab vedotin]. Thus, research priorities must be tailored according to tumour type, potentially focussing initially on settings where ADCs could replace chemotherapy. Many phase III ADC trials have been initiated based on positive phase I data and although these trials are larger than those conducted historically, prespecified criteria (e.g. patient numbers and magnitude of efficacy) should be met to justify proceeding directly to phase III. Importantly, although several ADCs have been successfully developed without mandatory biomarker selection, biomarker-driven ADC development enables rational patient selection, as illustrated by multiple ADCs (e.g. T-DXd, mirvetuximab soravtansine and telisotuzumab vedotin). The identification, development and validation of predictive biomarkers are therefore essential, particularly given several critical nuances, including the algorithms used to assess biomarker status and the type of specimen analysed, all of which may be influenced by temporal and spatial heterogeneity. Additional ADC research priorities include the optimisation of ADC constructs to enhance efficacy/tolerability and the identification of reliable ADC targets, including work to elucidate attributes of already-identified targets. Finally, considering the vast amount of ADC-related data being generated, artificial intelligence could be leveraged to analyse combined datasets and generate composite biomarkers, including tumour histology, optimal target expression thresholds, molecular alterations and activated pathways affecting payload activity and target function, to accelerate research.

01 Jul 2026·JTO clinical and research reports

Telisotuzumab Vedotin Monotherapy in Patients With Previously Treated c-Met Protein Overexpressing, Nonsquamous, EGFR Wild-type Advanced NSCLC: Updated Analysis of the LUMINOSITY Trial

Article

Author: Liu, Chunling ; Lu, Shun ; Lee, Se-Hoon ; Hrom, John S ; Xia, Summer ; Çiçin, Irfan ; Verma, Mukesh ; Planchard, David ; Katgi, Nuran ; Zer, Alona ; Reinmuth, Niels ; Horinouchi, Hidehito ; Baik, Christina ; Baijal, Shobhit ; Patel, Shilpen ; Daaboul, Nathalie ; Uema, Deise ; Girard, Nicolas ; Mansfield, Aaron S ; Yazici, Ozan ; Heist, Rebecca S ; Goldman, Jonathan ; Ciuleanu, Tudor ; Moskovitz, Mor ; Bar, Jair ; Camidge, D Ross ; Ratajczak, Christine

Introduction:

Telisotuzumab vedotin (Teliso-V) is a c-Met-directed antibody-drug conjugate comprising the monoclonal antibody telisotuzumab and the monomethyl auristatin E payload. Primary analysis of the phase 2 LUMINOSITY trial (NCT03539536) revealed Teliso-V monotherapy 1.9 mg/kg elicited durable responses and had generally manageable safety in patients with locally advanced or metastatic c-Met protein overexpressing, EGFR wild-type, nonsquamous NSCLC. We present updated outcomes with approximately 6 months longer follow-up and explore the impact of previous therapies.

Methods:

Patients (≥18 y; had previous therapy including ≤1 chemotherapy) received 1.9 mg/kg Teliso-V every 2 weeks. c-Met protein overexpression (clinical trial assay for MET [SP44] [Roche]) was defined as greater than or equal to 25% tumor cells with 3+ staining intensity (c-Met high: ≥50% 3+; c-Met intermediate: 25 to <50% 3+). Primary end point was the overall response rate by independent central review per the Response Evaluation Criteria in Solid Tumors version 1.1.

Results:

As of February 21, 2024, 172 patients received at least one dose of Teliso-V; 168 patients (c-Met high, n = 84; c-Met intermediate, n = 84) were evaluable for efficacy. The overall response rate was 29.2% (95% confidence interval [CI]: 22.4-36.7; c-Met high, 34.5% [24.5-45.7]; c-Met intermediate, 23.8% [15.2-34.3]). Median duration of response was 7.2 months (95% CI: 5.5-11.0; c-Met high, 7.2 [95% CI: 4.2-12.0]; c-Met intermediate, 7.2 [95% CI: 4.7-11.5]). Previous therapy (platinum, immune checkpoint inhibitors, or both) did not impact efficacy outcomes. The most common treatment-related adverse event was peripheral sensory neuropathy (any-grade: 31%; grade ≥3: 7%).

Conclusions:

Teliso-V monotherapy 1.9 mg/kg elicited durable responses, irrespective of the type of previous therapy received, and maintained a manageable safety profile in patients with c-Met protein overexpressing EGFR wild-type, nonsquamous NSCLC.

ClinicalTrialsgov ID number:

NCT03539536.

01 Jun 2026·CANCER

Mapping the antibody–drug‐conjugates landscape in non–small cell lung cancer: Where are we and where are we going?

Review

Author: Parisi, Claudia ; Planchard, David ; Barlesi, Fabrice

Abstract:

Antibody–drug conjugates (ADCs) represent a rapidly advancing therapeutic class in the treatment of non‐small cell lung cancer (NSCLC), offering targeted delivery of cytotoxic agents to tumor cells while minimizing off‐target toxicity. In recent years, several ADCs have emerged in both early (phase 1–2) and late (phase 3) clinical development, reflecting a growing recognition of their potential to improve outcomes in defined subsets of patients with advanced NSCLC. Late‐phase ADCs include trastuzumab deruxtecan (targeting HER2 [human epidermal growth factor receptor 2]), datopotamab deruxtecan and sacituzumab govitecan (targeting TROP2 [trophoblast cell‐surface antigen 2]), patritumab deruxtecan (targeting HER3), telisotuzumab vedotin (targeting c‐MET [cellular‐mesenchymal epithelial transition factor]), and sigvotatug vedotin (targeting IB6 [integrin beta‐6]). Research efforts are ongoing to explore novel payloads, linker technologies, and targets to expand the applicability of ADCs across broader NSCLC populations, including those with limited treatment options (e.g., EGFR ‐mutant disease in the context of treatment resistance). Despite their promise, challenges remain in optimizing patient selection, overcoming resistance mechanisms, and managing unique toxicity profiles. Ongoing, biomarker‐driven trials and combination strategies with immunotherapy or tyrosine kinase inhibitors hold the potential to further enhance the efficacy of ADCs. In this review, the authors highlight the current landscape and future directions of ADCs in NSCLC, emphasizing available results for compounds in late‐stage clinical development and different disease settings.

News (Medical) associated with Telisotuzumab vedotin

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

·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

14 Jan 2026

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JPM26: AbbVie Seeks Respect for Oncology Pipeline Following RemeGen Buy

iStock, vzphotos Primarily known as an immunology and neuroscience company, AbbVie wanted to put the biopharma world on notice during its J.P. Morgan presentation: its oncology portfolio is underappreciated. This week, the Illinois-based company dove into the sizzling PD-1/VEGF space with a licensing deal with China-based RemeGen. It’s a poorly kept secret in biopharma that AbbVie intends to become the leading neuroscience company in the near future. It was a point the Illinois-based behemoth reiterated during its J.P. Morgan presentation on Wednesday. “We anticipate being the largest neuroscience player in the industry soon,” Scott Reents, the company’s chief financial officer, said during the presentation. But this wasn’t the only point the company wanted to highlight. “And then the oncology pipeline is something we’re also very excited about that probably isn’t as appreciated as we’d like it to be,” Reents said. AbbVie took significant strides earlier this week to drive this point home, kicking off JPM26 with a licensing deal potentially worth nearly $5 billion for ex-China rights to RemeGen’s PD-1/VEGF bispecific. The pact—which will see AbbVie front $650 million—puts the company squarely in the middle of the hottest new trend in immuno-oncology, on which peers Bristol Myers Squibb, Pfizer and Merck have collectively bet more than $20 billion biobucks. “We feel that can be a very nice complement to our c-MET franchise,” Reents said. AbbVie’s Emrelis, a c-Met-directed antibody and microtubule inhibitor conjugate, was approved by the FDA last May for patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression. When asked about AbbVie’s overall approach to oncology R&D, Roopal Thakkar, executive vice president of research & development and chief scientific officer, said the company has “a very strong pipeline internally in a very active research group. . . . So we get assets out of that, a fairly consistent stream.” Indeed, AbbVie currently has 18 investigational drugs in various stages of clinical development listed in its pipeline. However, pointing to the RemeGen deal, Thakkar said, “I think you could anticipate from us looking externally for ways to complement the ADC franchise and on the [hematology] side as well.” The RemeGen pact is far from the only oncology deal AbbVie has inked in recent months. Earlier this month, the company committed more than $1 billion in milestones for the ex-China rights to a Phase III DLL3xDLL3 T cell engager from Suzhou Zelgen Biopharmaceuticals that could challenge Amgen’s Imdelltra. And heading into JPM, AbbVie was one of two companies rumored to be interested in buying Revolution Medicines and its pipeline of targeted drugs for RAS-driven cancers. AbbVie has since denied the rumor. While AbbVie is a well-diversified company with a significant presence in oncology and neuroscience, as well as eye care and aesthetics, it is possibly best known for its success in the immunology space, and the company’s executives spent half the presentation discussing its megablockbusters. Now three years past the Humira loss of exclusivity cliff, AbbVie provided 2027 guidance of $31 billion inclusively for successor products Skyrizi ($20 billion) and Rinvoq ($11 billion). AbbVie plans to provide 2026 guidance for the two drugs when it presents its full-year 2025 earnings on Feb. 4. Reents expressed confidence in the immunology duo’s revenue potential throughout the next several years. “The runway is really significant still through the end of the decade and even into the 2030s as we go forward,” he said. “And that’s based on a certain way these immunology markets are structured and the breadth and depth that we have with both of those assets.”

License out/inPhase 3Drug Approval

100 Deals associated with Telisotuzumab vedotin

External Link

KEGG	Wiki	ATC	Drug Bank
D11344	-	-	DB15104

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
c-Met positive non-squamous non-small cell lung cancer	United States	AbbVie, Inc.	14 May 2025

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Locally Advanced Lung Non-Squamous Non-Small Cell Carcinoma	Phase 3	-	AbbVie, Inc.	31 May 2024
Non-squamous non-small cell lung cancer	Phase 3	Japan	AbbVie, Inc.	02 Jan 2022
Non-squamous non-small cell lung cancer	Phase 3	Argentina	AbbVie, Inc.	02 Jan 2022
Non-squamous non-small cell lung cancer	Phase 3	Australia	AbbVie, Inc.	02 Jan 2022
Non-squamous non-small cell lung cancer	Phase 3	Austria	AbbVie, Inc.	02 Jan 2022
Non-squamous non-small cell lung cancer	Phase 3	Belgium	AbbVie, Inc.	02 Jan 2022
Non-squamous non-small cell lung cancer	Phase 3	Brazil	AbbVie, Inc.	02 Jan 2022
Non-squamous non-small cell lung cancer	Phase 3	Bulgaria	AbbVie, Inc.	02 Jan 2022
Non-squamous non-small cell lung cancer	Phase 3	Canada	AbbVie, Inc.	02 Jan 2022
Non-squamous non-small cell lung cancer	Phase 3	Chile	AbbVie, Inc.	02 Jan 2022

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03539536 (LUMINOSITY, WCLC2026)	Phase 2	Non-Small Cell Lung Cancer c-Met protein overexpression	92	Teliso-V (EGFR wildtype + c-Met overexpression + NSCLC nonsquamous + 2L+ treatment)	zglsadgblf(htfcszswvb) = The RRS was significantly associated with OS in both St: HR 5.5 (95% CI, 2.00-15.25; p=.0009); Sv: HR 16.3 (1.81-146.9; p=.0127). Kaplan-Meier analyses revealed significantly shorter survival in the high-risk group compared to the low-risk group in both St (P=.0009) and Sv (P=.0127). oifyyovwnx (attdrisvab )	Positive	12 Sep 2026
NCT05513703 (CTgov)	Phase 2	Metastatic Non-Squamous Non-Small Cell Lung Carcinoma \| c-Met positive non-squamous non-small cell lung cancer	9	Telisotuzumab Vedotin	nbiqhghjut = bmltlzyrtm bjiqivnnzk (hghbloxcla, fcprfgeipo - hfbnxxjnuw) View more	-	24 Oct 2025
NCT03539536 (LUMINOSITY, ESMO2025)	Phase 2	c-Met positive non-squamous non-small cell lung cancer c-Met protein overexpression	168	Teliso-V (pts with c-Met protein OE)	jafnsbtmyx(oysvopfnwv) = twaokmucxv hlfrmrtevz (qqowsyzfvg, 17.5 - 41.4)	Positive	17 Oct 2025
				Teliso-V (pts with c-Met high)	jafnsbtmyx(oysvopfnwv) = tzqrmzqmkt hlfrmrtevz (qqowsyzfvg, 18.7 - 46.3)
NCT03539536 (LUMINOSITY, WCLC2025)	Phase 2	squamous cell lung carcinoma Third line \| Second line MET overexpression	168	Telisotuzumab Vedotin 1.9 mg/kg (c-Met OE Total；No PN ≥3)	tdbvygzfhr(tsrojwfvfn) = upbsfftjjd ifxqcausqk (kqdaaiumkd ) View more	Positive	08 Sep 2025
				Telisotuzumab Vedotin 1.9 mg/kg (c-Met OE Total；PN ≥3)	tdbvygzfhr(tsrojwfvfn) = eddkwnxxgg ifxqcausqk (kqdaaiumkd ) View more
NCT03539536 (LUMINOSITY, ASCO2025)	Phase 2	c-Met positive non-small cell lung cancer Second line c-Met overexpression \| KRAS \| BRAF ... View more	83	Teliso-V 1.9 mg/kg	smipuciccs(hbpgommyrr) = fzorvmssoe ymmrcztapd (dlqhxlezua ) View more	Positive	30 May 2025
				Placebo	yedbgiqloq(oijtyhxchl) = vvraxkxdcz pznsqrjqvd (tmjgndqhim ) View more
NCT03539536 (LUMINOSITY, FDA_CDER) Manual	Phase 2	c-Met positive non-small cell lung cancer MET Overexpression	84	EMRELIS (high c-Met protein overexpression)	lftvrccukm(vdxvmyersw) = pbfjembbgs iednaozcwp (wquhkbjzwz, 24 - 46) View more	Positive	14 May 2025
NCT03539536 (LUMINOSITY, ESMO_ELCC2025) Manual	Phase 2	c-Met positive non-small cell lung cancer \| Advanced Lung Non-Small Cell Carcinoma EGFR Gene Mutation Negative \| MET Overexpression	172	Telisotuzumab vedotin 1.9 mg/kg (c-Met high: ≥50% 3+)	pcscmyuiey(jjlndgqnfx) = rmlanaoeej dterzpkkzt (cvnjqnooge, 24.5 - 45.7) View more	Positive	26 Mar 2025
				Telisotuzumab vedotin 1.9 mg/kg (c-Met intermediate [int]: 25 to <50% 3+)	pcscmyuiey(jjlndgqnfx) = ududizqalv dterzpkkzt (cvnjqnooge, 15.2 - 34.3) View more
NCT02099058 (Pubmed \| Ann Oncol) Manual	Phase 1	Non-Small Cell Lung Cancer Second line EGFR Mutation \| MET Overexpression	38	Telisotuzumab vedotin + osimertinib	peaagykxpu(wwpomwsxrf) = peripheral sensory neuropathy (50%), peripheral edema (32%), and nausea (24%) ilbllbnmax (foxubneeyo ) View more	Positive	01 Jan 2025
NCT03539536 (ESMO2024)	Phase 2	c-Met positive non-squamous non-small cell lung cancer	-	Telisotuzumab vedotin	udknrciqkz(mgnggzposu) = lyhodzsngd wgpgipqign (yofkbmukzo )	-	14 Sep 2024
				Placebo	udknrciqkz(mgnggzposu) = cylznifmim wgpgipqign (yofkbmukzo )
NCT02099058 (WCLC2024) Manual	Phase 1	c-Met positive non-small cell lung cancer MET Overexpression	30	Teliso-v (c-Met-positive tumor cells with 3+ intensity)	cthwwbdmyh(tjgybxrxyc) = twemifbeak tgvuxbzgzl (ojcziaaguv )	Positive	09 Sep 2024
				Teliso-v (below (A cutoff value of 25% c-Met-positive tumor cells with 3+ intensity))	cthwwbdmyh(tjgybxrxyc) = pxfmfzidys tgvuxbzgzl (ojcziaaguv )

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