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

Phase II study of telisotuzumab vedotin-tllv (Teliso-V) monotherapy in patients with previously untreated MET-amplified (METAmp) advanced non-squamous (NSQ) NSCLC (ESMO Asia 2025) - P2 | "Teliso-V monotherapy showed promising efficacy in treatment-naive pts with advanced NSQ METAmp NSCLC and a comparable safety profile to LUMINOSITY, with no new safety signals."

Clinical • Metastases • Monotherapy • P2 data • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • MET

Emrelis (telisotuzumab vedotin-tllv): targeting C-MET in non-small cell lung cancer. (PubMed, Ann Med Surg (Lond)) - No abstract available

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

Prevalence, molecular characterization, and prognosis of c-Met protein overexpression in a real-world cohort of patients with non-squamous non-small cell lung cancer. (PubMed, Acta Oncol) - "These data suggest that c-Met protein OE is associated with MET mRNA expression, shows limited overlap with other MET aberrations, and may be linked to poor prognosis in NSCLC."

Biomarker • IO biomarker • Journal • Real-world evidence • Retrospective data • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • MET • PD-L1

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: Oct 2025 ➔ Jul 2026

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

Evaluating the combined efficacy of Telisotuzumab Vedotin and artificial intelligence in the treatment of non-squamous non-small cell lung cancer: a narrative review focusing on pharmaceutical and technical insights. (PubMed, Front Oncol) - "Moreover, the combination with epidermal growth factor receptor inhibitors like Osimertinib and Erlotinib enhances outcomes, but the combination with immunotherapy (Nivolumab) provided negligible benefit. Teliso-V is highly effective in MET-high NSCLC with tolerable side effects. Its combination with AI holds the hope of early diagnosis, individualized treatment, and intelligent ADCs of the future, but for this to manifest, clinical data and biomarker improvements must materialize."

IO biomarker • Journal • Review • Infectious Disease • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • MET

Telisotuzumab vedotin monotherapy in patients with previously treated c-Met protein–overexpressing non- squamous EGFR wildtype advanced NSCLC: Updated analysis of the LUMINOSITY trial (JADPRO 2025) - "INTRODUCTIONTelisotuzumab vedotin (Teliso or TelisoV) is a B-class anti-c-Met antibody drug conjugate (ADC) that has demonstrated efficacy and a tolerable safety profile in preliminary studies.Preliminary data suggest a c-Met high protein expression status may enrich for response to TelisoV, though c-Met overexpression and c-Met activating mutations do not always overlap.The phase 2, multicenter, nonrandomized LUMINOSITY Trial (NCT03539944) evaluated TelisoV 5.6 mg/kg every 2 weeks (Q2W) in patients with previously treated, c-Met positive (IHC 2+ or 3+), non-squamous (NSQ) EGFR wildtype (WT) advanced NSCLC.LUMINOSITY Trial Cohort 4 (c-Met High) met the primary endpoint of objective response rate (ORR) in Stage 1.We present an updated safety and efficacy analysis of TelisoV 5.6 mg/kg Q2W in patients with c-Met protein overexpressing EGFR WT NSCLC (Cohort 4, c-Met High) from the LUMINOSITY Trial.METHODSEligible patients had histologically or cytologically confirmed stage..."

Clinical • Metastases • Monotherapy • Fatigue • Inflammation • Interstitial Lung Disease • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Pneumonia • Pulmonary Disease • Respiratory Diseases • Solid Tumor • EGFR • MET

Companion diagnostic assay for c-Met protein overexpression (OE) to identify patients (pts) who may benefit from telisotuzumab vedotin (Teliso-V) (ESMO 2025) - P2 | "Conclusions A CDx assay was developed with samples from the LUMINOSITY trial. Clinical efficacy in pts with c-Met OE and c-Met high by CDx assay remains similar to CTA selected patients, showing that the CDx assay can identify pts with NSCLC who may benefit from Teliso-V therapy."

Clinical • Companion diagnostic • Diagnostic assay • 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) - P2 | "Conclusions Ocular surface AEs seen in the LUMINOSITY study were low-grade (mostly grade ≤2) and manageable with protocol-recommended supportive care measures and/or dose modifications, and did not result in Teliso-V discontinuation. Proper pt education on the ocular effects of Teliso-V, along with timely identification and care, are important for effective management of these AEs."

Clinical • Lung Cancer • Lung Non-Squamous Non-Small Cell 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) - P2 | "The most common TEAE leading to dose reduction or interruption was peripheral sensory neuropathy, a known cumulative toxicity associated with MMAE-based ADCs. These exploratory analyses suggest dose modifications due to TEAEs did not negatively impact efficacy."

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

METRIX: International real-world (RW) study of c-Met protein overexpression (OE) in patients (pts) with locally advanced (LA)/metastatic NSCLC (ESMO 2025) - P2 | "Background In the LUMINOSITY study (NCT03539536), telisotuzumab vedotin, a c-Met (MET) protein-directed ADC, showed promising antitumor activity in pts with NSQ NSCLC with c-Met OE...Determining associations of c-Met OE with other biomarkers could aid therapy decisions. Table: 1923P Total Int c-Met OE High c-Met OE N=476 Y n=167 N n=309 Y n=106 N n=370 EGFR mutation, n/N (%) 118/430 (27) 46/153 (30) 72/277 (26) 30/98 (31) 88/332 (27) ALK1 translocation, n/N (%) 20/384 (5) 8/139 (6) 12/245 (5) 5/87 (6) 15/297 (5) ROS1 translocation, n/N (%) 9/367 (3) 5/132 (4) 4/235 (2) 4/84 (5) 5/283 (2) KRAS , n/N (%) 116/291 (40) 45/106 (43) 71/185 (38) 27/64 (42) 89/227 (39) BRAF, n/N (%) 13/310 (4) 4/111 (4) 9/199 (5) 3/75 (4) 10/235 (4) PD-L1, tumor proportion score ≥50%, n/N (%) 111/382 (29) 64/138 (46) 47/244 (19) 47/91 (52) 64/291 (22) MET amp, n/N (%) 10/117 (9) 7/48 (15) 3/69 (4) 5/34 (15) 5/83 (6) MET ex 14 skipping mutation, n/N (%) 4/213 (2) 4/80 (5) 0/133 (0) 3/54 (6)..."

Clinical • IO biomarker • Metastases • Real-world • Real-world evidence • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK1 • BRAF • EGFR • KRAS • MET • PD-L1 • ROS1

AbbVie to Present New Data at ESMO 2025 Reinforcing Leadership in Advancing Targeted Therapies for Solid Tumors (AbbVie Press Release)

Clinical data • Platinum resistant • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Ovarian Cancer

Advanced Antibody-Drug Conjugates Design: Innovation in Linker Chemistry and Site-Specific Conjugation Technologies. (PubMed, Chembiochem) - "Several ADCs have been approved for clinical use in oncology, including Mylotarg, Adcetris, Kadcyla, Besponsa, Polivy, Lumoxiti, Padcev, Enhertu, Trodelvy, Aidixi, Zynlonta, Tivdak, Elahere, Datroway, and Emrelis. The toxicity profiles of ADCs and strategies are also addressed to mitigate off-target effects and systemic toxicity. Overall, this review provides a comprehensive overview of the current state of linker and conjugation technologies in ADC development."

Journal • Review • Oncology

Assessment of Telisotuzumab Vedotin Drug-Drug Interaction Potential Using Physiologically-Based Pharmacokinetic Modeling and Simulations. (PubMed, J Clin Pharmacol) - "DDI magnitude was comparable to that observed between another approved ADC with the same MMAE payload (brentuximab vedotin) and ketoconazole and rifampin. The current PBPK simulations demonstrated a lack of perpetrator effect of Teliso-V on midazolam, a sensitive CYP3A substrate. The current analysis provides important information on Teliso-V DDI potential and further demonstrates the utility of PBPK models, particularly in oncology, where dedicated DDI studies are challenging."

Journal • PK/PD data • 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

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

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

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

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

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