For sufferers with MET exon 14-altered NSCLC, Tepmetko was related to frequent unwanted effects, though the security profile is taken into account manageable.
Amongst sufferers with MET exon 14-altered non-small cell lung most cancers (NSCLC), therapy with Tepmetko (tepotinib) was related to a excessive frequency of unwanted effects, though the security profile is taken into account manageable, based on a pooled security evaluation of cohorts A and C of the section 2 VISION trial.
Notably, these findings had been according to prior reviews from the trial. Within the pooled security evaluation of cohorts A and C (313 sufferers), any-grade unwanted effects occurred in 99% of sufferers, and grade 3 (extreme) or greater unwanted effects had been reported in 68.4% of sufferers. Therapy-related unwanted effects had been noticed in 91.7% of sufferers, together with grade 3 or greater in 36.1% of sufferers. Any-grade critical unwanted effects and critical treatment-related unwanted effects occurred in 54.6% and 16% of sufferers, respectively. Unwanted effects led to dose reductions in 33.2%, therapy interruptions in 43.8% and everlasting discontinuation in 15.7% of sufferers. These charges of treatment-related unwanted effects had been 33.2%, 43.8% and 15.7%, respectively. Moreover, 13.7% of sufferers skilled a aspect impact that led to loss of life, three of which had been therapy associated.
The commonest treatment-related unwanted effects included peripheral edema (any-grade, 67.7%; grade 3 or greater, 11.8%), hypoalbuminemia (25.2%; 3.8%), nausea (23.3%; 0.6%), diarrhea (22.7%; 0.3%), elevated blood creatinine ranges (22.0%; 1.3%), alanine aminotransferase (ALT) stage elevation (14.1%; 2.2%), decreased urge for food (11.5%; 0.3%), aspartate aminotransferase stage elevation (11.2%; 1.9%) and amylase stage improve (10.5%; 1.9%).
Glossary
Glossary:
Peripheral edema: swelling of the extremities.
Hypoalbuminemia: low ranges of albumin within the blood.
Alanine aminotransferase (ALT) stage elevation: a sign of liver harm.
Aspartate aminotransferase stage elevation: a sign of liver or muscle harm.
Pleural effusion: accumulation of fluid between the lungs and the chest wall.
Asthenia: fatigue.
Pneumonitis: irritation of the lungs.
ECOG efficiency standing: a technique of measuring sufferers’ capacity to finish day by day duties, with decrease scores indicating larger independence.
In complete, 37.4% of sufferers required not less than one dose discount. The commonest any-grade treatment-related aspect impact resulting in dose discount, therapy interruption and therapy discontinuation was peripheral edema (15.3%, 18.8%, and 6.1% of sufferers, respectively). Different treatment-related unwanted effects resulting in dose reductions had been generalized edema (3.2%), edema (2.2%), pleural effusion (1.6%), elevated blood creatinine ranges (2.6%), hypoalbuminemia (1.3%), fatigue (1.0%), asthenia (1.0%) and localized edema (1.0%). Different treatment-related unwanted effects resulting in therapy interruptions included elevated blood creatinine ranges (5.8%), generalized edema (4.8%), edema (3.5%), pleural effusion (3.2%), elevated ALT ranges (2.6%), localized edema (2.2%) and nausea (2.2%). Different treatment-related unwanted effects resulting in therapy discontinuation included edema (1.3%), generalized edema (1.0%), pleural effusion (1.0%), interstitial lung illness (1.0%) and pneumonitis (1.0%).
Moreover, health-related high quality of life (HRQOL) patient-reported final result (PRO) scores remained steady with Tepmetko use. Investigators noticed no significant change in European Organisation for Analysis and Therapy of Most cancers High quality of Life Core Questionnaire (EORTC QLQ-C30) or EuroQol 5-Dimension 5-Degree (EQ-5D-5L) scores as much as 228 weeks. On the finish of therapy, amongst sufferers evaluated for HRQOL, the imply change from baseline for the EORTC QLQ-C30 international well being standing (GHS) was –7.1 and the imply change for the EuroQol visible analogue scales (EQ-VAS) was –10; optimistic values signified enchancment. The imply modifications from baseline within the EORTC QLQ-lung most cancers (LC13) symptom scores for cough, dyspnea and chest ache, respectively, had been –6.1, 7.1 and –2.3; detrimental values signified enchancment. Moreover, the median time to deterioration of the EORTC QLQ-LC13 symptom scores for cough, chest ache, and dyspnea had been 36.5 months, 30.4 months and 5.5 months, respectively.
“All through the VISION trial, sufferers accomplished questionnaires evaluating their QOL earlier than and whereas receiving [Tepmetko],” Dr. Enriqueta Felip, lead research writer and head of the Thoracic Most cancers Unit at Hospital Universitari de la Vall d’Hebron in Barcelona, Spain, and coauthors defined within the conclusion of the poster presentation. “General, sufferers reported that well being and QOL remained steady whereas receiving [Tepmetko]. Particular scores referring to signs skilled by sufferers with lung most cancers had been improved throughout therapy for signs akin to cough and chest ache and remained steady for shortness of breath.”
What Was the Design of the VISION Trial of Tepmetko in Sufferers With MET-Altered NSCLC?
The VISION trial was a single-arm research evaluating Tepmetko in sufferers with superior NSCLC harboring MET exon 14 skipping alterations.The research evaluated Tepmetko at a dose of 500 mg orally as soon as day by day and comprised three cohorts.
Eligible sufferers had been not less than 18 years of age, had histologically or cytologically confirmed NSCLC with MET exon 14 skipping alterations detected by liquid biopsy and/or tissue biopsy, measurable illness and an ECOG efficiency standing of 0 or 1. Prior immunotherapy was permitted.
Sufferers had been excluded if their tumors harbored EGFR mutations or ALK rearrangements, if that they had acquired greater than two prior traces of systemic remedy, or if that they had prior publicity to MET or HGF inhibitors.
What Have been the Baseline Affected person Demographics within the VISION NSCLC Trial?
The median age of sufferers with MET exon 14 skipping NSCLC was 72 years. In complete, 50.8% of sufferers had been feminine, 73.8% of sufferers had an ECOG efficiency standing of 1 and 47.6% of sufferers had acquired prior therapy.
At research entry, 47.6% of sufferers had acquired not less than one prior systemic remedy. The median therapy period was 7.5 months and 19 sufferers remained on Tepmetko for not less than 48 months.
References
- Felip E, Ferrara R, Veillon R, et al. Security and patient-reported outcomes with tepotinib in sufferers with METex14 skipping NSCLC: ≥3 years follow-up of VISION. Offered at: 2025 IASLC World Convention on Lung Most cancers; September 6-10, 2025; Barcelona, Spain. Poster P3.12.40.
- Tepotinib section II in NSCLC harboring MET alterations (VISION). ClinicalTrials.gov. Up to date August 14, 2025. Accessed September 9, 2025. https://www.clinicaltrials.gov/research/NCT02864992
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