Emrelis (telisotuzumab vedotin-tllv) / AbbVie - LARVOL DELTA

MET Alterations in Cancer and MET-Targeted Therapy: Detection Strategies, Treatment Efficacy, and Emerging Technologies. (PubMed, Target Oncol) - "This review summarizes the frequency of MET alterations across different cancer types and the clinical validation of MET alterations in MET-targeted therapies, offering a detailed comparison of objective response rates (ORR) for therapies including crizotinib, capmatinib, tepotinib, savolitinib, telisotuzumab vedotin, telisotuzumab adizutecan, and amivantamab. Additionally, emerging technologies such as circulating tumor DNA (ctDNA) and circulating tumor cell (CTC) analyses have been investigated for their potential to improve MET alterations detection. This review also highlights studies that demonstrate the potential of MET ctDNA and CTC analyses to predict treatment responses and identify resistance mechanisms in MET-targeted therapies."

Journal • Review • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • MET

Incidence and Severity of Interstitial Lung Disease Associated With Antibody-Drug Conjugates in NSCLC and SCLC: A Meta-Analysis (IASLC-WCLC 2025) - "In NSCLC, the highest pooled incidence of any-grade ILD was seen with patritumab deruxtecan (23%) and trastuzumab deruxtecan (22%), followed by datopotamab deruxtecan (9%), telisotuzumab vedotin (7%), and sacituzumab govitecan (1%)...Treatment discontinuation due to ILD in NSCLC was highest with telisotuzumab vedotin combined with erlotinib (36%), followed by trastuzumab deruxtecan (9%) and patritumab deruxtecan (7%)...In SCLC, any-grade ILD incidence was 8% with rovalpituzumab tesirine, with no reported grade ≥3 ILD events...HER2/HER3-targeted, deruxtecan-containing ADCs demonstrated the highest ILD rates, while other ADCs such as sacituzumab govitecan had minimal reported toxicity. These findings highlight the need for agent-specific ILD monitoring and support the consideration of ADC design, including target and payload, when evaluating pulmonary safety and guiding clinical decision-making."

Retrospective data • Interstitial Lung Disease • Lung Cancer • Non Small Cell Lung Cancer • Pulmonary Disease • Respiratory Diseases • Small Cell Lung Cancer • Solid Tumor • ERBB3 • HER-2

M14-237: A Study Evaluating the Safety, Pharmacokinetics (PK), and Preliminary Efficacy of ABBV-399 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=237 | Active, not recruiting | Sponsor: AbbVie | Trial completion date: Nov 2025 ➔ Aug 2026 | Trial primary completion date: Nov 2025 ➔ Aug 2026

Trial completion date • Trial primary completion date • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • MET

Peripheral Neuropathy and Efficacy of Telisotuzumab Vedotin in c-Met Protein-Overexpressing NSCLC: LUMINOSITY Study (IASLC-WCLC 2025) - P2 | "Patients with grade ≥3 PN (n=17) had a longer median duration of treatment and improved efficacy outcomes compared with those without grade ≥3 events (n=151). Although the number of patients with grade ≥3 PN was limited, these findings suggest that patients who develop these events are generally patients who remain on treatment for an extended time, indicating they are deriving benefit from Teliso-V."

Clinical • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Pain • Solid Tumor • EGFR • MET

LUMINOSITY: Study of Telisotuzumab Vedotin (ABBV-399) in Participants With Previously Treated c-Met+ Non-Small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=270 | Active, not recruiting | Sponsor: AbbVie | Trial primary completion date: Jul 2026 ➔ Oct 2025

Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • MET

Treatment outcomes in patients (pts) with advanced c-Met overexpressing (OE) EGFR wildtype (WT) nonsquamous (NSQ) NSCLC who had telisotuzumab vedotin (Teliso-V) dose modifications in the LUMINOSITY trial (ESMO 2025) - No abstract available

Clinical • Metastases • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • MET

Ocular surface disorders in patients with c-Met protein–overexpressing NSCLC treated with telisotuzumab vedotin in the LUMINOSITY study (ESMO 2025) - No abstract available

Clinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • MET

Companion diagnostic assay for c-Met protein overexpression (OE) to identify patients (pts) who may benefit from telisotuzumab vedotin (Teliso-V) (ESMO 2025) - No abstract available

Clinical • Companion diagnostic • Diagnostic assay • Oncology • MET

Evolving roles of MET as a therapeutic target in NSCLC and beyond. (PubMed, Nat Rev Clin Oncol) - "To date, the MET tyrosine-kinase inhibitors (TKIs) capmatinib, tepotinib and savolitinib have been approved for the treatment of advanced-stage METex14-mutant NSCLC...Indeed, in May 2025, the MET-directed ADC telisotuzumab vedotin was approved by the FDA for patients with previously treated advanced-stage nonsquamous NSCLC overexpressing MET (≥50% of tumour cells with 3+ staining on immunohistochemistry). Understanding the unique MET-related adverse events will be crucial when incorporating these agents into daily clinical practice. In this Review, we highlight the rationale for targeting MET alterations across various solid tumour types and provide a summary of the clinical efficacy and toxicity profiles of the approved and emerging MET-targeted TKIs, monoclonal or bispecific antibodies and ADCs."

Journal • Review • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • MET

LUMINOSITY: Study of Telisotuzumab Vedotin (ABBV-399) in Participants With Previously Treated c-Met+ Non-Small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=270 | Active, not recruiting | Sponsor: AbbVie | Trial completion date: Oct 2025 ➔ Aug 2026 | Trial primary completion date: Oct 2025 ➔ Jul 2026

Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • MET

Management of MET-Driven Resistance to Osimertinib in EGFR-Mutant Non-Small Cell Lung Cancer. (PubMed, Genes (Basel)) - "In this context, the bispecific EGFR/MET antibody amivantamab has demonstrated encouraging efficacy, regardless of MET alterations. Furthermore, the combination of the ADC telisotuzumab vedotin and osimertinib has been associated with activity in EGFR-mutant, c-MET protein-overexpressing, osimertinib-resistant NSCLC...The success of these targeted approaches relies on tissue re-biopsy at progression and accurate molecular profiling. Yet, tumor heterogeneity and procedural limitations may challenge the feasibility of re-biopsy, making biomarker-agnostic strategies viable alternatives."

Journal • Review • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Telisotuzumab Vedotin: First Approval. (PubMed, Drugs) - "On 14 May 2025, telisotuzumab vedotin received accelerated approval in the USA for the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression, as determined by an FDA-approved test, who have received a prior systemic therapy. This article summarizes the milestones in the development of telisotuzumab vedotin leading to this first approval for NSCLC."

Journal • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • MET

Telisotuzumab vedotin (Emrelis) for non-small cell lung cancer. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Telisotuzumab vedotin: The first-in-class c-Met-targeted antibody-drug conjugate granted FDA accelerated approval for treatment of non-squamous non-small cell lung cancer (NSCLC). (PubMed, Drug Discov Ther) - "This therapeutic agent addresses a critical unmet need within a molecularly defined NSCLC subpopulation, marking a substantial advancement in c-Met-targeted oncology. The regulatory authorization and clinical use of telisotuzumab vedotin may significantly advance precision medicine for NSCLC, though an ongoing phase III trial will further confirm its efficacy and safety and determine its eligibility for full regulatory approval in the future."

FDA event • Journal • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • MET

Telisotuzumab Vedotin Elicits Responses in c-MET–Overexpressing NSCLC, Regardless of Prior Therapy (OncLive) - P2 | N=270 | LUMINOSITY (NCT03539536) | Sponsor: AbbVie | "Telisotuzumab vedotin-tllv (Emrelis) demonstrated durable responses in patients with c-MET–overexpressing, nonsquamous, EGFR-wildtype non–small cell lung cancer (NSCLC), regardless of whether they received prior treatment with a platinum-based therapy, immune checkpoint inhibitor (ICI), or both, according to an analysis of the phase 2 LUMINOSITY trial (NCT03539536) presented at the 2025 ASCO Annual Meeting. Results showed that objective response rates (ORRs) were similar across prior therapy arms. The ORR was 29.3% (95% CI, 22.4%-36.9%) if treated with prior platinum-based therapy, 28.9% (95% CI, 21.4%-37.3%) for prior ICI treatment, and 28.8% (95% CI, 21.2%-37.3%)."

P2 data • Non Small Cell Lung Cancer

Association of genomic alterations in circulating tumor DNA (ctDNA) with clinical response to telisotuzumab vedotin (Teliso-V) in 2L+ EGFR wildtype (EGFRwt) non-squamous non-small cell lung cancer (NSCLC) patients (pts) with c-Met overexpression (OE). (ASCO 2025) - P2 | "ctDNA is a promising biomarker in predicting Teliso-V activity. Confirmatory research is planned in larger pt cohorts and/or with tissue-based NGS analyses."

Circulating tumor DNA • Clinical • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • BRAF • EGFR • FGFR3 • FGFR4 • HER-2 • KIF5B • KRAS • MET

LUMINOSITY, a phase 2 study of telisotuzumab vedotin in patients with c-Met protein–overexpressing non-squamous EGFR-wildtype advanced NSCLC: Efficacy outcomes by prior therapy. (ASCO 2025) - P2 | "This analysis demonstrated that Teliso-V elicited durable responses in pts with c-Met protein–OE NSQ EGFR-WT NSCLC regardless of whether they had received prior platinum or platinum + ICI therapies; the efficacy outcomes in these subgroups were consistent with those in the overall pt population. aPer independent central review. DOR, duration of response."

Clinical • IO biomarker • Metastases • P2 data • Fatigue • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Pain • Solid Tumor • EGFR • MET

TeliMET NSCLC-04: A phase 2, open-label, randomized, global study of 2 telisotuzumab vedotin regimens in patients with previously treated c-Met protein–overexpressing, locally advanced/metastatic non-squamous EGFR wildtype non-small cell lung cancer. (ASCO 2025) - P2 | "The primary efficacy endpoint is objective response based on RECIST v1.1 by blinded independent central review (BICR). Secondary endpoints are pharmacokinetics, patient-reported outcomes, duration of response by BICR, progression-free survival by BICR, and overall survival."

Clinical • Metastases • P2 data • Interstitial Lung Disease • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Pain • Pulmonary Disease • Respiratory Diseases • Solid Tumor • EGFR • MET

Diffuse interstitial lung disease induced by antibody-drug conjugates (PubMed, Rev Mal Respir) - "Among the many ADCs being developed, several can cause ILD of varying grades and intensity. Knowledge of their risks, diagnostic and therapeutic modalities is required in order to quickly detect and treat ADC-induced ILD."

Journal • Review • Interstitial Lung Disease • Lung Cancer • Nephrology • Non Small Cell Lung Cancer • Oncology • Pulmonary Disease • Renal Disease • Respiratory Diseases • Solid Tumor • CEACAM5 • ERBB3 • HER-2 • MET

Efficacy and Safety of Antibody-Drug Conjugates for Lung Cancer Therapy: A Systematic Review of Randomized and Non-Randomized Clinical Trials. (PubMed, Pharmaceutics) - "Five ADCs were evaluated: trastuzumab deruxtecan (T-DXd), trastuzumab emtansine (T-DM1), telisotuzumab vedotin, patritumab deruxtecan, and datopotamab deruxtecan (Dato-DXd)...Dato-DXd demonstrated improved ORR (26.4% vs. 12.8%) and PFS (4.4 vs. 3.7 months) compared to docetaxel...While ADCs offer significant clinical benefits, careful patient selection and proactive management of adverse events remain crucial. Ongoing and future trials will further refine the role of ADCs in personalized NSCLC treatment, potentially expanding their tumor-agnostic use to broader patient populations."

Clinical • IO biomarker • Journal • Review • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • HER-2 • MET • TACSTD2

NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Non-Small Cell Lung Cancer: Version 4.2025. (NCCN)

NCCN guideline • Non Small Cell Lung Cancer

NeoGenomics Launches c-MET CDx Assay to Guide Treatment Decisions for Advanced Non-Small Cell Lung Cancer (Businesswire) - "NeoGenomics, Inc...announced the commercial launch of c-MET CDx for NSCLC, its c-MET companion diagnostic immunohistochemistry (IHC) assay. The test is now available to oncologists and pathologists nationwide, supporting treatment selection for patients with advanced non-small cell lung cancer (NSCLC) with a 48-hour turnaround time....It is designed to help identify patients who may be eligible for newly approved targeted therapies, including EMRELIS (telisotuzumab vedotin-tllv), which was recently approved by the U.S. Food and Drug Administration (FDA)."

Diagnostic • Launch • Non Small Cell Lung Cancer • Oncology

Teliso-V Plus Osimertinib Active, Tolerable in TKI-Resistant NSCLC (Oncology Nursing News) - P1/1b | N=237 | NCT02099058 | Sponsor: AbbVie | "Telisotuzumab vedotin (Teliso-V; Emrelis) plus osimertinib (Tagrisso) showed clinical activity and was well tolerated in patients with EGFR-mutant non–small cell lung cancer (NSCLC) and c-Met overexpression who had progressed after prior osimertinib, according to results from arm E of a phase 1/1b trial (NCT02099058). After a median follow-up of 7.4 months, the objective response rate (ORR) was 50.0% (95% CI, 33.4%-66.6%) per independent central review (ICR) and 52.6% (95% CI, 35.8%-69.0%) per investigator assessment. All responses were confirmed partial responses. The median duration of response was not reached (NR) per ICR and 8.0 months per investigator assessment. Median progression-free survival (PFS) was 7.4 months (95% CI 5.4-NR) and 6.8 months (95% CI, 5.3-9.2) per ICR and investigator, respectively."

P1 data • Non Small Cell Lung Cancer

Clinical Value of Testing for c-Met Protein Overexpression in Patients With Non-Small Cell Lung Cancer (ISPOR 2025) - "OBJECTIVES: This study evaluated the clinical value of testing patients with advanced/metastatic EGFR wild-type non-squamous non-small cell lung cancer (NSCLC) with MET immunohistochemistry (IHC) to identify those with high and high/intermediate c-Met protein overexpression (OE), who would then be eligible for telisotuzumab vedotin (Teliso-V), an investigational antibody-drug conjugate... The model findings suggest clinical value in implementing testing for c-Met protein OE among all eligible NSCLC patients, as demonstrated by improved outcomes among patients when MET IHC testing is conducted."

Clinical • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • MET

FDA grants accelerated approval to telisotuzumab vedotin-tllv for NSCLC with high c-Met protein overexpression (FDA) - "On May 14, 2025, the Food and Drug Administration granted accelerated approval to telisotuzumab vedotin-tllv (Emrelis, AbbVie Inc.), a c-Met-directed antibody and microtubule inhibitor conjugate, for adults with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression [≥50% of tumor cells with strong (3+) staining], as determined by an FDA-approved test, who have received a prior systemic therapy. FDA also approved the VENTANA MET (SP44) RxDx Assay (Roche Diagnostics) as a companion diagnostic test to aid in detecting c-Met protein overexpression in patients with non-squamous NSCLC who may be eligible for treatment with Emrelis. Efficacy was evaluated in the LUMINOSITY study (NCT03539536)..."

Accelerated approval • Diagnostic • Evidence highlight • FDA approval • Non Small Cell Lung Cancer • MET