Trial results for Telisotuzumab Vedotin in adult participants with advanced/metastatic non-squamous non-small cell lung cancer (NSCLC) were posted on ClinicalTrials.gov on 2025-10-24. The Phase 2 study reported an objective response rate (ORR) of 33.3% and a median overall survival (OS) of 17.5 months.
Background
Telisotuzumab Vedotin is an investigational drug being developed for the treatment of MET amplified non-squamous NSCLC. Non-small cell lung cancer (NSCLC) is a type of lung cancer where cancer cells form in the tissues of the lung.
Trial design
The study (NCT05513703) was a Phase 2 trial designed to assess disease activity of intravenously (IV) infused Telisotuzumab Vedotin in adult participants with advanced/metastatic non-squamous non-small cell lung cancer (NSCLC). The study enrolled 9 participants and was terminated. The purpose was to determine how Telisotuzumab Vedotin affects the disease state in previously untreated participants with MET amplified non-squamous NSCLC.
Key results
The trial reported several key measurements for participants treated with Telisotuzumab Vedotin:
- The Objective Response Rate (ORR) as assessed by an Independent Central Review (ICR) was 33.3% (percentage of participants).
- The median Duration of Response (DoR) was 8.5 months.
- The Disease Control Rate (DCR) was 44.4% (percentage of participants).
- The median Progression Free Survival (PFS) per ICR was 4.0 months.
- The median Overall Survival (OS) was 17.5 months.
Changes from baseline in cough, as measured by the cough item of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13), were also reported at various time points:
- Mean change: -8.33 (Standard Deviation: 15.430)
- Mean change: -11.11 (Standard Deviation: 34.427)
- Mean change: -5.56 (Standard Deviation: 13.608)
- Mean change: -11.11 (Standard Deviation: 17.213)
- Mean change: -13.33 (Standard Deviation: 29.814)
- Mean change: -26.67 (Standard Deviation: 27.889)
- Mean change: -25.00 (Standard Deviation: 31.914)
What this means
The results from this Phase 2 study provide initial insights into the activity of Telisotuzumab Vedotin in previously untreated adult participants with MET amplified non-squamous NSCLC. An objective response rate of 33.3% and a median overall survival of 17.5 months suggest potential clinical activity in this challenging patient population. These findings contribute to the understanding of Telisotuzumab Vedotin as an investigational treatment option.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT05513703, titled "A Study to Assess Disease Activity of Intravenously (IV) Infused Telisotuzumab Vedotin in Adult Participants With Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC)," were posted on 2025-10-24 on clinicaltrials.gov.