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 70 to 80 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.

NCT05513703

/ TerminatedPhase 2

Phase 2, Open-Label Study in Subjects With Previously Untreated MET Amplified Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

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 determine how telisotuzumab vedotin affects the disease state in adult participants with previously untreated participants with MET amplified non-squamous NSCLC. Change in disease activity will be assessed.
Telisotuzumab vedotin is an investigational drug being developed for the treatment of MET amplified non-squamous NSCLC. Participants receive intravenously (IV) infused of telisotuzumab vedotin. Approximately 70 adult participants with previously untreated MET amplified locally advanced/metastatic non-squamous NSCLC will be enrolled in the study in approximately 110 sites worldwide.
Participants will receive IV telisotuzumab vedotin every 2 weeks until meeting study drug discontinuation criteria.
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 Date21 Nov 2022

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

620

Literatures (Medical) associated with Telisotuzumab vedotin

31 Dec 2025·mAbs

Antibodies to watch in 2025

Review

Author: Kapoor, Vaishali ; Crescioli, Silvia ; Kaplon, Hélène ; Reichert, Janice M. ; Visweswaraiah, Jyothsna ; Wang, Lin

The commercial development of antibody therapeutics is a global enterprise involving thousands of biopharmaceutical firms and supporting service organizations. To date, their combined efforts have resulted in over 200 marketed antibody therapeutics and a pipeline of nearly 1,400 investigational product candidates that are undergoing evaluation in clinical studies as treatments for a wide variety of diseases. Here, we discuss key events in antibody therapeutics development that occurred during 2024 and forecast key events related to the late-stage clinical pipeline that may occur in 2025. In particular, we report on 21 antibody therapeutics granted a first approval in at least one country or region during 2024, including bispecific antibodies tarlatamab (IMDELLTRA®), zanidatamab (Ziihera®), zenocutuzumab (BIZENGRI®), odronextamab (Ordspono®), ivonescimab (®), and antibody-drug conjugate (ADC) sacituzumab tirumotecan (®). We also discuss 30 investigational antibody therapeutics for which marketing applications were undergoing review by at least one regulatory agency, as of our last update on December 9, 2024, including ADCs datopotamab deruxtecan, telisotuzumab vedotin, patritumab deruxtecan, trastuzumab botidotin, becotatug vedotin, and trastuzumab rezetecan. Of 178 antibody therapeutics we include in the late-stage pipeline, we summarize key data for 18 for which marketing applications may be submitted by the end of 2025, such as bi- or multispecific antibodies denecimig, sonelokimab, erfonrilimab, and anbenitamab. Key trends in the development and approval of antibody formats such as bispecifics and ADCs, as well as clinical-phase transition and global approval success rates for these antibody formats, are reported.

31 Dec 2025·mAbs

A bispecific antibody-drug conjugate targeting pCAD and CDH17 has antitumor activity and improved tumor-specificity

Author: Gesner, Thomas ; Logel, Claude ; Xie, Kathleen T. ; Cebe, Regis ; Wu, Nila C. ; Li, Xun ; Shi, Xingyi ; Velazquez, Roberto ; Simmons, Quincey ; Tschantz, William R. ; Hainzl, Dominik ; Barzaghi-Rinaudo, Patrizia ; Sagar, Vivek ; Korn, Joshua ; Malamas, Anthony ; Mercan, Samuele ; Green, Andrew ; McLaughlin, Margaret ; Huber, Thomas ; Mueller, Kathrin ; Synan, Alyssa ; D’Alessio, Joseph A.

P-cadherin (pCAD) and LI-cadherin (CDH17) are cell-surface proteins belonging to the cadherin superfamily that are both highly expressed in colorectal cancer.This co-expression profile presents a novel and attractive opportunity for a dual targeting approach using an antibody-drug conjugate (ADC).In this study, we used a unique avidity-driven in vitro screening approach to generate pCAD x CDH17 bispecific antibodies that selectively target cells expressing both antigens over cells expressing only pCAD or only CDH17.Based on in vitro binding and inhibition of cell proliferation results, we selected a lead bispecific antibody to link to the cytotoxic payload monomethyl auristatin E (MMAE) to generate a pCAD x CDH17 bispecific MMAE ADC.In in vivo dual flank mouse models, we demonstrated antitumor activity of the bispecific ADC in tumors expressing both antigens but not in tumors expressing only pCAD or only CDH17.Overall, the preclin. data presented here support the proof-of-concept bispecific antibody discovery approach, demonstrating a rational design for screening antibodies by prioritizing cross-arm avid IgGs to target dual-pos. cells.

12 May 2025·ACS Biomaterials Science & Engineering

Enhanced Targeted Drug Delivery System to Control Avidity and Drug Encapsulation Using E2 Nanocages and SpyTag/SpyCatcher

Article

Author: Gone, Geetanjali B. ; Park, Sun Hee ; Jeong, Myeong Seon ; Chung, Sang J. ; Cho, Younghun ; Lee, Yeong Geun ; Ahn, Dohee

Although antibody-drug conjugates offer advanced targeted anticancer therapy that overcomes the limitations of conventional chemotherapy and therapeutic antibodies, they are restricted in their capacity to carry multiple hydrophobic payloads. Protein nanocages have emerged as versatile therapeutic platforms for targeted drug delivery, offering advantages like precise molecular assembly, biocompatibility, and multivalent targeting. This study presents the development of engineered E2 nanocages functionalized with anti-HER2 single-chain variable fragments (scFv) using the SpyTag/SpyCatcher ligation system to achieve controlled scFv display valency. The results demonstrate that increasing anti-HER2 scFv valency enhances HER2 binding affinity via avidity effects, with the highest valency nanocages showing the highest binding avidity. Furthermore, cysteine residues were introduced into the E2 nanocages to enable conjugation with monomethyl auristatin E (MMAE) through maleimide chemistry, achieving efficient drug loading. The resulting MMAE-conjugated nanocages displayed potent, subnanomolar cytotoxicity in HER2-positive SKBR3 and BT-474 cell lines while sparing HER2-negative MDA-MB-231 cells at concentrations up to 1 nM. These results underscore the critical role of scFv valency in enhancing HER2 targeting and highlight the potential of E2 protein nanocages as specific, potent platforms for targeted cancer therapy. In this study, we developed an enhanced targeted drug delivery system using E2 nanocages and scFv with SpyCatcher/SpyTag ligation to regulate binding avidity and encapsulate hydrophobic drugs. The modular design and pH-sensitive dissociation of these nanocages establish a foundation for next-generation precision medicine strategies.

News (Medical) associated with Telisotuzumab vedotin

27 May 2025

·www.prnewswire.com

AbbVie Features New Data Across Difficult-to-Treat Solid Tumors and Blood Cancers at ASCO 2025, Highlighting Breadth and Depth of its Oncology Portfolio

- Key oral presentations highlight new data from AbbVie's novel investigational antibody-drug conjugates (ADCs) including telisotuzumab adizutecan (ABBV-400, Temab-A) in advanced non-small cell lung cancer (NSCLC), ABBV-706 in high-grade neuroendocrine neoplasms (NENs) and pivekimab sunirine (PVEK) in blastic plasmacytoid dendritic cell neoplasm (BPDCN). NORTH CHICAGO, Ill., May 27, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that key data from its broad oncology portfolio will be showcased across multiple oral presentations and posters at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting (May 30 - June 3, 2025). These new data highlight significant progress in AbbVie's robust oncology pipeline, across a range of difficult-to-treat solid tumors and blood cancers. "The data we're presenting at this year's ASCO reflect the breadth and depth of our oncology pipeline and our unwavering commitment to research that could transform outcomes for patients facing cancer," said Roopal Thakkar, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "These presentations underscore our leadership in driving scientific innovation to address some of the most pressing unmet needs in oncology today by leveraging our innovative platforms such as ADCs." An oral presentation on investigational telisotuzumab adizutecan (ABBV-400, Temab-A), a next-generation, c-Met directed antibody-drug conjugate (ADC) with a novel topoisomerase 1 inhibitor (Top1i) payload, will showcase: Preliminary safety and efficacy results in 41 patients with pre-treated, advanced epidermal growth factor receptor (EGFR)-mutated non-squamous non-small cell lung cancer (NSCLC) from the dose expansion part of a Phase 1 study (NCT05029882).1 Patients received a median of 3 prior lines of therapies and 93% of patients had prior anti-EGFR treatment. The objective response rate (ORR) was 63%.1 High ORR was observed regardless of c-Met protein expression levels.1 At the time of data cut-off, 54% of responders experienced a ≥6 months duration of response (DoR).1 The most common any-grade TEAEs in ≥30% of patients were anemia (63%), nausea (61%), vomiting (37%), decreased appetite (34%), and neutropenia (34%).1 Additional data with 4 months follow-up will be presented at ASCO. Temab-A is also being evaluated in multiple ongoing clinical trials including a Phase 1/2 Study (NCT06772623) in first-line NSCLC without actionable genomic alterations in combination with budigalimab (AbbVie's investigational programmed cell death 1 inhibitor), a Phase 2 study (NCT06107413) in second-line metastatic colorectal cancer (CRC) in combination with fluorouracil, folinic acid and bevacizumab, and a Phase 3 study (NCT06614192) as monotherapy in patients with c-Met overexpressing refractory metastatic CRC. "The anti-tumor activity of Temab-A in patients with pre-treated, advanced EGFR-mutated non-squamous NSCLC is encouraging and supports further exploration of this novel ADC in this setting," said Ross Camidge, M.D., Ph.D, University of Colorado Cancer Center, United States and principal investigator of the trial. "Temab-A appears to have a manageable safety profile and continues to show promising clinical activity in advanced NSCLC, which is associated with poor prognosis." Additional oral presentations will highlight new safety and efficacy data for ABBV-706, a SEZ6-directed ADC with a Top1i payload, and pivekimab sunirine (PVEK), a novel ADC designed to target CD123: In a Phase 1 open-label study of ABBV-706 monotherapy, 64 patients with high-grade neuroendocrine neoplasms (NENs), a diverse group of rare and aggressive solid tumors, received ABBV-706 monotherapy IV at 1.3–3.5 mg/kg once every 3 weeks.2,3 The entire cohort had an ORR of 31.3%, and a median DoR of 5.6 months.2 The most common grade ≥3 TEAEs (cumulative across all dose levels), were anemia (45%), neutropenia (33%), and thrombocytopenia (21%).2 Additional data will be presented at ASCO. This ongoing study (NCT05599984) is evaluating ABBV-706 as monotherapy, or in combination with budigalimab, carboplatin, or cisplatin, in patients with advanced solid tumors expressing SEZ6, including small-cell lung cancer, NENs and high-grade Central Nervous System tumors. Results from the open-label, multicenter Phase 1b/2 CADENZA trial (NCT03386513) of PVEK monotherapy in patients with previously untreated or relapsed/refractory (R/R) blastic plasmacytoid dendritic cell neoplasm (BPDCN), a highly aggressive and rare type of blood cancer, demonstrated clinical benefit.4,5 The results show that among 33 untreated patients, the primary endpoint of composite complete response (CCR) rate, defined as CR + clinical CR (CR with minimal skin abnormality), was 70% (95% CI, 51.3-84.4) with a median duration of CCR of 9.8 months. ORR was 85%.4 In the 51 patients with R/R BPDCN, the CCR rate was 14% with a median duration of CCR of 9.2 months. ORR was 35%.4 Among all the 84 patients enrolled, the most common grade ≥3 TEAEs were peripheral edema (12%).4 TEAEs led to discontinuation in 9% and 7% of patients with first-line and R/R BPDCN, respectively. 4 Additional data will be presented at ASCO. PVEK is also being evaluated in a Phase 1/2 study (NCT04086264) in R/R and newly diagnosed acute myeloid leukemia. "Over the past few years, we've significantly expanded our ADC portfolio to investigate a broad range of solid tumors and blood cancers, reflecting our deep commitment to transforming cancer care through targeted therapies and biomarker driven approaches," said Daejin Abidoye, M.D., vice president, therapeutic area head of solid tumors, AbbVie. "These results highlight the potential of our investigational medicines to offer a meaningful clinical benefit in multiple difficult-to-treat cancers, where current treatment options are limited." Further information on AbbVie clinical trials is available at . Additional details on key presentations at ASCO are available below and the full ASCO Annual Meeting 2025 abstracts are available here. Telisotuzumab adizutecan, ABBV-706, pivekimab sunirine, etentamig, livmoniplimab, budigalimab, ABBV-291 and ABBV-969 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. Venetoclax, ibrutinib, epcoritamab, telisotuzumab vedotin are approved medicines being investigated for additional uses. Safety and efficacy have not been established for these unapproved additional uses. EPKINLY ®/TEPKINLY ® (epcoritamab) is being co-developed by Genmab and AbbVie as part of the companies' oncology collaboration. The companies share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization. VENCLEXTA®/VENCLYXTO® (venetoclax) is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S. IMBRUVICA® (ibrutinib) is jointly developed and commercialized by Pharmacyclics LLC, an AbbVie company and Janssen Biotech, Inc. U.S. Prescribing Information for AbbVie Medicines Please see full Prescribing Information for EMRELIS™ (telisotuzumab vedotin-tllv) Please see full Prescribing Information for EPKINLY® (epcoritamab-bysp) Please see full Prescribing Information for IMBRUVICA® (ibrutinib) Please see full Prescribing Information for VENCLEXTA® (venetoclax tablets) 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, neuroscience and eye care – 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 (formerly Twitter) 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 2024 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: Camidge R, Raimbourg J, Lee Y-G, et al. Telisotuzumab Adizutecan (ABBV-400; Temab-A), a c-Met Protein-Targeting Antibody-Drug Conjugate, in Patients With Advanced EGFR Mutated Non-Squamous NSCLC: Results From a Phase 1 Study. Abstract 8512 presented at the American Society of Clinical Oncology Annual Meeting, 2025. Chicago, Illinois. Cooper A, Chandana S, Furqan M, et al. Safety and efficacy of ABBV-706, a seizure-related homolog protein (SEZ6)- targeting antibody-drug conjugate, in high-grade neuroendocrine neoplasms. Abstract 105 presented at the American Society of Clinical Oncology Annual Meeting, 2025. Chicago, Illinois. Sultana Q, Kar J, Verma A, et al. A Comprehensive Review on Neuroendocrine Neoplasms: Presentation, Pathophysiology and Management. J Clin Med. 2023 Aug 5;12(15):5138. doi: 10.3390/jcm12155138. Pemmaraju N, Marconi G, Montesinos P, et al. Efficacy and safety of pivekimab sunirine (PVEK) in patients (pts) with blastic plasmacytoid dendritic cell neoplasm (BPDCN) in the CADENZA study. Abstract 6502 presented at the American Society of Clinical Oncology Annual Meeting, 2025. Chicago, Illinois. Cazzato G, Capuzzolo M, Bellitti E, et al. Blastic Plasmocytoid Dendritic Cell Neoplasm (BPDCN): Clinical Features and Histopathology with a Therapeutic Overview. Hematol Rep 2023;15(4):696-706 doi: 10.3390/hematolrep15040070. Contacts: SOURCE AbbVie WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultASCOPhase 1ADCPhase 2

21 May 2025

·www.businesswire.com

Guardant Health Introduces Comprehensive Immunohistochemistry Testing for Solid Tumors

PALO ALTO, Calif.--(BUSINESS WIRE)--Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced the addition of a full suite of immunohistochemistry (IHC) testing to the company’s portfolio of tumor molecular profiling tests. This new set of tests will help oncologists identify tumor subtypes and match cancer patients to the most effective targeted therapies. IHC testing is a special staining process that detects specific proteins within a tissue sample, known as tumor biomarkers, that can be used to determine the characteristics of a tumor and identify the most appropriate targeted cancer therapy. The new Guardant IHC test suite provides comprehensive testing for key biomarkers in all solid tumors (such as lung, breast, gastric and ovarian cancers). This includes c-MET, the target of Emrelis™ (telisotuzumab vedotin-tllv), an antibody-drug conjugate recently approved by the U.S. Food and Drug Administration (FDA) for the treatment of c-MET-expressing non-squamous non-small cell lung cancer (NSCLC). “The information about tumor characteristics garnered from advanced IHC testing will complement the multidimensional insights we are currently providing to oncologists through our recently introduced Guardant360 Tissue multiomic tumor profiling test,” said Helmy Eltoukhy, Guardant Health chairman and co-CEO. “This expansion of our portfolio will allow us to offer cancer care teams more comprehensive tissue testing capabilities through a single source to help them make more informed decisions about therapy selection and optimize outcomes for their patients.” The comprehensive IHC menu covers the following biomarkers: HER2, MMR, PD-L1, c-MET, ER, PR, Ki-67, CLDN18, and FOLR1. About Guardant Health Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardant is transforming patient care and accelerating new cancer therapies by providing critical insights into what drives disease through its advanced blood and tissue tests, real-world data and AI analytics. Guardant tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and treatment selection for patients with advanced cancer. For more information, visit guardanthealth.com and follow the company on LinkedIn, X (Twitter) and Facebook. Forward-Looking Statements This press release contains forward-looking statements within the meaning of federal securities laws, including statements regarding the potential utilities, values, benefits and advantages of Guardant Health’s liquid biopsy tests or assays, which involve risks and uncertainties that could cause the actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors. These and additional risks and uncertainties that could affect Guardant Health’s financial and operating results and cause actual results to differ materially from those indicated by the forward-looking statements made in this press release include those discussed under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operation” and elsewhere in its Annual Report on Form 10-K for the year ended December 31, 2024, and in its other reports filed with or furnished to the Securities and Exchange Commission thereafter. The forward-looking statements in this press release are based on information available to Guardant Health as of the date hereof, and Guardant Health disclaims any obligation to update any forward-looking statements provided to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based, except as required by law. These forward-looking statements should not be relied upon as representing Guardant Health’s views as of any date subsequent to the date of this press release.

Drug ApprovalImmunotherapy

15 May 2025

·pharma.economictimes.indiatimes.com

US FDA approves AbbVie's drug for a type of lung cancer

Bengaluru: The U.S. Food and Drug Administration has approved AbbVie's drug to treat adults with a type of lung cancer who have received previous treatment, the drugmaker said on Wednesday. The treatment, branded as Emrelis, belongs to a class of drugs known as antibody-drug conjugates , which act as "guided-missiles" that target only cancer cells while sparing healthy cells, unlike conventional chemotherapy. Emrelis was approved for a type of non-squamous non-small cell lung cancer (NSCLC), for which patients were previously treated with other drugs but the disease still spread to other parts of the body. These patients also showed an excess of c-Met protein, which is known to trigger tumor development and resistance to certain therapies. According to the National Institutes of Health, about 25 per cent-37 per cent of patients with this type of lung cancer exhibit high c-Met protein overexpression. NSCLC is the most common type of lung cancer in the United States, accounting for roughly 197,000 new NSCLC cases in a year, according to the American Cancer Society. The FDA's accelerated approval of Emrelis was based on a mid-stage trial of 84 patients, where the drug showed an overall response rate of 35 per cent. It is currently being evaluated in a late-stage trial. Other treatment options for NSCLC include Merck's blockbuster Keytruda and AstraZeneca's Tagrisso, which belong to different classes of drugs. (Reporting by Sriparna Roy, Christy Santhosh and Siddhi Mahatole in Bengaluru; Editing by Shailesh Kuber and Leroy Leo)

Drug ApprovalAccelerated ApprovalADCClinical Result

100 Deals associated with Telisotuzumab vedotin

External Link

KEGG	Wiki	ATC	Drug Bank
D11344	-	-	DB15104

R&D Status

Approved

10 top approved records.

to view more data

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.

to view more data

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

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03539536 (LUMINOSITY, FDA_CDER) Manual	Phase 2	c-Met positive non-small cell lung cancer MET Overexpression	84	EMRELIS (high c-Met protein overexpression)	qkxzyxdaho(mwidildhgb) = mholwhyoxa uwmlctwdag (erabhkxajl, 24 - 46) View more	Positive	14 May 2025
NCT03539536 (LUMINOSITY, ESMO_ELCC2025) Manual	Phase 2	c-Met positive non-small cell lung cancer EGFR Gene Mutation Negative \| MET Overexpression	172	Telisotuzumab vedotin 1.9 mg/kg (c-Met high: ≥50% 3+)	sucuiulchw(gbfifulzio) = ihmwrozkem nyjchkqsfi (fhnyyielzb, 24.5 - 45.7) View more	Positive	26 Mar 2025
NCT03539536 (LUMINOSITY, ESMO_ELCC2025) Manual	Phase 2		172	Telisotuzumab vedotin 1.9 mg/kg (c-Met intermediate [int]: 25 to <50% 3+)	sucuiulchw(gbfifulzio) = lxiyvwjxpg nyjchkqsfi (fhnyyielzb, 15.2 - 34.3) View more	Positive	26 Mar 2025
NCT02099058 (Pubmed \| Ann Oncol) Manual	Phase 1	Non-Small Cell Lung Cancer Second line EGFR Mutation \| MET Overexpression	38	Telisotuzumab vedotin + osimertinib	vfpmiooxyv(jyfzmfqgwy) = peripheral sensory neuropathy (50%), peripheral edema (32%), and nausea (24%) yyfcpfpkor (kerszcgvha ) View more	Positive	01 Jan 2025
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)	zxwxoznksc(htvnmqmqll) = puqsxqwazm ukkslsfitn (iqsnwnnvsv )	Positive	09 Sep 2024
NCT02099058 (WCLC2024) Manual	Phase 1		30	Teliso-v (below (A cutoff value of 25% c-Met-positive tumor cells with 3+ intensity))	zxwxoznksc(htvnmqmqll) = rombdsygpu ukkslsfitn (iqsnwnnvsv )	Positive	09 Sep 2024
NCT03539536 (LUMINOSITY, Pubmed) Manual	Phase 2	c-Met positive non-small cell lung cancer c-Met protein-overexpressing	172	Telisotuzumab vedotin (Teliso-V)	qqldkktoms(qntxfbcayh) = fgkpekdamz wcqfkfzmbu (hmxbxdngoc, 21.7 - 36.2) View more	Positive	06 Jun 2024
NCT03539536 (LUMINOSITY, Pubmed) Manual	Phase 2		172	Telisotuzumab vedotin (c-Met high)	qqldkktoms(qntxfbcayh) = hxoneijwsa wcqfkfzmbu (hmxbxdngoc, 24.2 - 46.2) View more	Positive	06 Jun 2024
NCT03539536 (LUMINOSITY, ASCO2024) Manual	Phase 2	Non-Small Cell Lung Cancer Third line c-Met protein overexpression	172	Telisotuzumab vedotin (c-Met High)	giowlaqqtn(krjngzkfsy) = ibiftjnupr tamvyzbhcf (lftttjivwr, 24.2 - 46.2) View more	Positive	24 May 2024
NCT03539536 (LUMINOSITY, ASCO2024) Manual	Phase 2		172	Telisotuzumab vedotin (c-Met Int)	giowlaqqtn(krjngzkfsy) = xfxkqcgsam tamvyzbhcf (lftttjivwr, 14.4 - 33.4) View more	Positive	24 May 2024
NCT02099058 (ESMO_ASIA2023)	Phase 1	EGFR-mutated non-small Cell Lung Cancer EGFR-mut \| c-Met overexpressing	41	Telisotuzumab vedotin (Teliso-V) + Osimertinib	yiqfuwalvg(hzzutqnldp) = cpkwwgqizq mbdmchnywz (btvvvqpiba ) View more	-	03 Dec 2023
NCT04928846 (TeliMET NSCLC-01, ESMO_ASIA2023)	Phase 3	EGFR positive Non-squamous non-small cell lung cancer c-Met overexpressing \| EGFR wildtype	-	Teliso-V	lowkpzunen(pphvacfcjt) = roqrspntrm ebanipywvb (lfpeutjxjh ) View more	-	02 Dec 2023
NCT03539536 (LUMINOSITY, PRNewswire) Manual	Phase 2	c-Met positive non-small cell lung cancer c-MET Amplification	-	Telisotuzumab-vedotin (c-Met High)	njqexfukmv(wrcqnjdiia) = yzpilaungy mndxjajaeb (ymvuwdwukb ) View more	Positive	29 Nov 2023
NCT04928846 (TeliMET NSCLC-01, ESMO2023)	Phase 3	Non-squamous non-small cell lung cancer c-Met overexpressing \| EGFR WT	698	Teliso-V	edlfwhjgeq(lhaftrgcar) = jkkabmstoc ytjuzjdjwr (wiwztebwbe, 24 - 51)	-	23 Oct 2023

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