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

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

The anti-tumor activity of a novel anti-Her2 and anti-c-Met bispecific antibody-drug conjugate (AACR 2025) - "Its cytotoxic potency was comparable to Trastuzumab-MMAE (T-MMAE) in Her2-high expressing cancer cells and to Telisotuzumab vedotin (Teliso-V) in c-Met-high expressing cancer cells. The novel anti-Her2/anti-c-Met bispecific ADC BB-205 demonstrates superior anti-tumor activity in preclinical studies. BB-205 shows promising therapeutic potential as a first-in-class ADC drug candidate."

Genito-urinary Cancer • Kidney Cancer • Oncology • Pancreatic Cancer • Renal Cell Carcinoma • Solid Tumor • MET

TeliMET NSCLC-04: A Study to Assess Adverse Events and How Intravenously (IV) Infused Telisotuzumab Vedotin (ABBV-399) Moves Through the Body as a Monotherapy in Adult Participants With Previously Treated Non-Squamous Non-Small Cell Lung Cancer (NSCLC) (clinicaltrials.gov) - P2 | N=150 | Recruiting | Sponsor: AbbVie | N=100 ➔ 150

Adverse events • Enrollment change • Monotherapy • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Elucidating the mechanism of clinical Teliso-v (cMet-MMAE ADC) and osimertinib combination: A CAV1 and EGFR multi-protein complex controls endolysosomal trafficking of Teliso-V (AACR 2025) - "In addition to osimertinib, other EGFR inhibitors including erlotinib, gefitnib, or afatinib also enhanced Teliso-V EL trafficking which is consistent with the effect of EGFR-MT signaling in suppressing c-Met ADC EL trafficking. Chronic and acute treatment with osimertinib displaces EGFR/c-Met/CAV-1 multimeric signaling complexes leading to improved lysosomal processing of c-Met-targeted ADCs and enhanced tumor cytotoxicity. This study provides mechanistic insights into the combination of Teliso-V and osimertnib in 2L+ EGFRMT NSCLC patients in the clinic."

Clinical • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CAV1 • EGFR • MET

Clinical relevance and translatability of NSCLC patient-derived xenograft (PDX) models for evaluating cMET-targeted therapies (AACR 2025) - "Antibody Drug Conjugates (ADCs), such as c-MET targeting telisotuzumab-vedotin, are emerging as a promising therapy for EGFR inhibitor-progressed NSCLC, but understanding ADC efficacy across diverse profiles of advanced tumors remains a challenge...Notably, Champions low-passage models preserved the molecular and histological features of the original patient tumors, including mutations and copy number variations, which were critical for understanding the response to therapy. Our study highlights the translational potential of Champions PDX models, serving as a platform for investigating the efficacy and mechanisms of resistance to targeted therapies."

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

Telisotuzumab vedotin: Accelerated approval in US for 2L high c-met NSCLC in Q2 2025 (AbbVie) - Q1 2025 Results

FDA approval • Lung Cancer • Non Small Cell Lung Cancer • Oncology

Recent advances in therapeutic strategies for non-small cell lung cancer. (PubMed, J Hematol Oncol) - "For instance, amivantamab has been approved as a treatment for epidermal growth factor receptor (EGFR)-mutant NSCLC, including those with EGFR exon 20 insertion mutations. Additionally, antibody-drug conjugates (ADCs), including HER2-targeting trastuzumab deruxtecan, TROP2-targeting ADCs, HER3-targeting patritumab deruxtecan, and MET-targeting telisotuzumab vedotin, have demonstrated promising outcomes in several clinical trials. This review summarizes the recent advancements and challenges associated with the evolving NSCLC therapeutic landscape."

IO biomarker • Journal • Review • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • ERBB3 • HER-2

Telisotuzumab vedotin: Accelerated approval in US for 2L NSCLC in 2025 (AbbVie) - Q4 2024 Results

Accelerated approval • Lung Cancer • Non Small Cell Lung Cancer • Oncology

Telisotuzumab vedotin monotherapy in patients with previously treated c-Met protein–overexpressing nonsquamous EGFR wildtype advanced NSCLC: Updated analysis of the LUMINOSITY trial (ELCC 2025) - P2 | "In this updated analysis, Teliso-V monotherapy 1.9 mg/kg in pts with c-Met protein OE EGFR WT NSQ NSCLC continued to demonstrate durable responses, with an enrichment in the c-Met–high population. No new safety signals were observed.Table 18PEfficacy endpointsDOR, duration of response; OS, overall survival; PFS, progression-free survival.aPer independent central review."

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

Treatment of c-MET Antibody-Drug Conjugate Asymptomatic Pneumonitis with a Novel Steroid Regimen in Non-Small Cell Lung Cancer: A Case Report. (PubMed, J Immunother Precis Oncol) - "We report a case of a patient with metastatic non-small cell lung cancer taking the ADC telisotuzumab vedotin (Teliso V) plus osimtertinib who developed ADC-induced pneumonitis despite clinical benefit. This patient was able to tolerate treatment for a prolonged period on a novel steroid regimen, using steroids when pneumonitis was asymptomatic but radiologically evident and as a daily suppressant. This treatment strategy may have implications in the broader management of ADC-interstitial lung disease/pneumonitis and underscores its potential mechanisms."

Journal • Inflammation • Interstitial Lung Disease • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pneumonia • Pulmonary Disease • Respiratory Diseases • Solid Tumor • MET

ABBV – 400: A c-Met Targeting ADC With Activity in CRC & MET Amplified Tumours (ADC London 2025) - "• Exploring the elusive targeting of c-Met protein • Reviewing the limitations of small molecule inhibitors and antibodies • Discussing next generation ADCs that are effective at targeting the c-Met protein: Teliso-V, Temab-A"

Oncology • MET

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 2024 ➔ Nov 2025 | Trial primary completion date: Nov 2024 ➔ Nov 2025

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

Teliso-V and osimertinib: the METamorphosis of EGFR-mutant lung cancer? (PubMed, Ann Oncol) - No abstract available

Journal • Lung Cancer • Oncology • Solid Tumor • EGFR

Antibodies to watch in 2025. (PubMed, MAbs) - "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..."

Journal • Review • Oncology

A Study to Assess Adverse Events and How Intravenously (IV) Infused Telisotuzumab Vedotin (ABBV-399) Moves Through the Body as a Monotherapy in Adult Participants With Previously Treated Non-Squamous Non-Small Cell Lung Cancer (NSCLC) (clinicaltrials.gov) - P2 | N=100 | Recruiting | Sponsor: AbbVie | Not yet recruiting ➔ Recruiting

Adverse events • Enrollment open • Monotherapy • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor