Evidenzprofil_VISION_Tepotinib
Lungenkarzinom · Version 5.1
| A Phase II Single-arm Trial to Investigate Tepotinib in Advanced (Locally Advanced or Metastatic) Non-small Cell Lung Cancer With METex14 Skipping Alterations or MET Amplification (VISION) (NCT02864992) | |||||
| Short Name | Design | Population | Intervention | Comparator | Outcomes |
|---|---|---|---|---|---|
| VISION MS200095-0022, 2015-005696-24 |
N/a (not applicable), Single Group, Phase 2 Open Label study | with Stage 3-4 and ECOG 0-1 Advanced (Stage IIIB/IV) Non-small Cell Lung Cancer (NSCLC) With MET Exon 14 (METex14) Skipping Alterations or MET Amplification for 1st Line or 2nd Line treatment | 1. Tepotinib Unkown Population (N=0) 2. Tepotinib Safety Population (N=152)1 3. Tepotinib Combined Biopsy (N=99)2 4. Tepotinib Liquid Biopsy (N=66)3 5. Tepotinib Tissue Biopsy (N=60)4 |
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| Levels of Evidence | |||||
| GRADE | ⊕⊖⊖⊖a,b,c | We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect. | |||
| 1: Patients MET exon 14 positive received Tepotinib 500 mg daily; 2: Patients MET exon 14 positive by liquid or tissue or both biopsy received Tepotinib 500 mg daily and had ≥9 months follow-up (primary efficacy population); 3: Patients MET exon 14 positive by liquid biopsy received Tepotinib 500 mg daily and had ≥9 months follow-up; 4: Patients MET exon 14 positive by tissue biopsy received Tepotinib 500 mg daily and had ≥9 months follow-up | |||||
| a: Open Label Study;b: Non-randomized Study;c: Studydesign - Phase II | |||||
| Outcome | Tepotinib Combined Biopsy N=99 |
GRADE | |
|---|---|---|---|
| Tepotinib in Non-Small-Cell Lung Cancer with MET Exon 14 Skipping Mutations. Combined Biopsy Population: Paik, PK 2020. Tepotinib in Non-Small-Cell Lung Cancer with MET Exon 14 Skipping Mutations.. ; 383 (10); 931-943* | |||
| Dichotomous Outcomes | |||
| OS - Time To Event | N=99 | 17.1 [12; 26.8] | ⊕⊕⊕⊕ |
| PFS - Time To Event1 | N=99 | 8.5 [6.7; 11] | ⊕⊖⊖⊖a |
| DOR - Time To Event1 | N=99 | 11.1 [7.2; ] | ⊕⊖⊖⊖ |
| ORR - TuDD1 | N=99 | 46 (46.46%) | ⊕⊖⊖⊖ |
| Age, years | |||
| < 75 | N=54 | 27 (50%) | |
| ≥ 75 | N=45 | 19 (42.2222%) | |
| ECOG PS | |||
| 0 | N=22 | 13 (59.0909%) | |
| 1 | N=77 | 33 (42.8571%) | |
| Ethnie | |||
| Asian | N=21 | 13 (61.9048%) | |
| Caucasian/White | N=74 | 31 (41.8919%) | |
| Geographic region | |||
| Asia | N=19 | 12 (63.1579%) | |
| Europe | N=56 | 23 (41.0714%) | |
| Noth America | N=24 | 11 (45.8333%) | |
| Line of therapy | |||
| First line | N=43 | 19 (44.186%) | |
| Second line | N=33 | 16 (48.4848%) | |
| Second or later line | N=56 | 27 (48.2143%) | |
| Third or later line | N=23 | 11 (47.8261%) | |
| Prior platinum-based chemotherapy for metastatic disease | |||
| No | N=47 | 20 (42.5532%) | |
| Yes | N=49 | 26 (53.0612%) | |
| Sex | |||
| Female | N=45 | 22 (48.8889%) | |
| Male | N=54 | 24 (44.4444%) | |
| Smoking history | |||
| No | N=45 | 16 (35.5556%) | |
| Yes | N=46 | 26 (56.5217%) | |
| Outcome | Tepotinib Safety Population N=152 |
GRADE | |
| Tepotinib in Non-Small-Cell Lung Cancer with MET Exon 14 Skipping Mutations. - Safety Population: Paik, PK 2020. Tepotinib in Non-Small-Cell Lung Cancer with MET Exon 14 Skipping Mutations.. ; 383 (10); 931-943** | |||
| Dichotomous Outcomes | |||
| AE (Any) | N=152 | 149 (98.03%) | ⊕⊖⊖⊖ |
| AE (CTCAE ≥3) | N=152 | 83 (54.61%) | ⊕⊖⊖⊖ |
| AE-Disc (Any) | N=152 | 17 (11.18%) | ⊕⊖⊖⊖ |
| SAE (Any) | N=152 | 73 (48.03%) | ⊕⊖⊖⊖ |
| TSAE (Any) | N=152 | 23 (15.13%) | ⊕⊖⊖⊖ |
| Outcome | Tepotinib Liquid Biopsy N=66 |
GRADE | |
| Tepotinib in Non-Small-Cell Lung Cancer with MET Exon 14 Skipping Mutations. Liquid Biopsy Population: Paik, PK 2020. Tepotinib in Non-Small-Cell Lung Cancer with MET Exon 14 Skipping Mutations.. ; 383 (10); 931-943*** | |||
| Dichotomous Outcomes | |||
| PFS - Time To Event1 | N=66 | 8.5 [5.1; 11] | ⊕⊖⊖⊖a |
| DOR - Time To Event1 | N=66 | 9.9 [7.2; ] | ⊕⊖⊖⊖ |
| ORR - TuDD1 | N=66 | 32 (48.48%) | ⊕⊖⊖⊖ |
| Outcome | Tepotinib Tissue Biopsy N=60 |
GRADE | |
| Tepotinib in Non-Small-Cell Lung Cancer with MET Exon 14 Skipping Mutations. Tissue Biopsy Population: Paik, PK 2020. Tepotinib in Non-Small-Cell Lung Cancer with MET Exon 14 Skipping Mutations.. ; 383 (10); 931-943**** | |||
| Dichotomous Outcomes | |||
| PFS - Time To Event1 | N=60 | 11.0 [5.7; 17.1] | ⊕⊖⊖⊖a |
| DOR - Time To Event1 | N=60 | 15.7 [9.7; ] | ⊕⊖⊖⊖ |
| ORR - TuDD1 | N=60 | 30 (50%) | ⊕⊖⊖⊖ |
| *Database cutoff: 31.12.2019 **Database cutoff: 31.12.2019 ***Database cutoff: 31.12.2019 ****Database cutoff: not reported |
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| 1: by Independent review committee | |||
| a: Missing individual analysis of combined endpoint componenets (progression) | |||
| AE: Adverse Events; AE-Disc: Adverse Events Leading to Treatment Discontinuation; Any: Any Grade; CTCAE ≥3: Common Terminology Criteria for Adverse Events, Grade ≥3; DOR: Duration Of Response; ORR: Objective Response Rate; OS: Overall Survival; PFS: Progression-Free Survival; SAE: Serious Adverse Events; TSAE: Treatment-related Serious Adverse Events; TuDD: Time to Definitive Deterioration | |||
| Outcome | Tepotinib Unkown Population N=0 |
GRADE | |
| Tepotinib in Non-Small-Cell Lung Cancer with MET Exon 14 Skipping Mutations. Unkown Population: Paik, PK 2020. Tepotinib in Non-Small-Cell Lung Cancer with MET Exon 14 Skipping Mutations.. ; 383 (10); 931-943***** | |||
| Continuous Outcomes | |||
| EORTC QLQ-LC13 (Coughing) | N=0 | -12.9 (27.1) | ⊕⊖⊖⊖a,b |
| EORTC QLQ-LC13 (Dyspnea) | N=0 | 2.0 (20.5) | ⊕⊖⊖⊖a,b |
| EORTC QLQ-LC13 (Pain in chest) | N=0 | -3.0 (24.7) | ⊕⊖⊖⊖a,b |
| EORTC QLQ-C30 (Global Health Status) | N=0 | 6.4 (19.9) | ⊕⊖⊖⊖a,b |
| EORTC QLQ-C30 (Physical Function) | N=0 | -1.4 (19.4) | ⊕⊖⊖⊖a,b |
| EORTC QLQ-C30 (Role Function) | N=0 | 3.8 (33.7) | ⊕⊖⊖⊖a,b |
| EORTC QLQ-C30 (Cognitive Function) | N=0 | -2.3 (21.7) | ⊕⊖⊖⊖a,b |
| EORTC QLQ-C30 (Emotional Function) | N=0 | 7.6 (22.5) | ⊕⊖⊖⊖a,b |
| EORTC QLQ-C30 (Social Function) | N=0 | 4.9 (27.3) | ⊕⊖⊖⊖a,b |
| *****Database cutoff: 31.12.2019 | |||
| a: Unvollständige Berichterstattung der erhobenen Items; b: analysierte Population nicht genannt | |||
| Cognitive Function: Cognitive Function; Coughing: Coughing; Dyspnea: Dyspnea; Emotional Function: Emotional Function; EORTC QLQ-C30: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30; EORTC QLQ-LC13: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Lung Cancer 13 Module; Global Health Status: Global Health Status; Pain in chest: Pain in chest; Physical Function: Physical Function; Role Function: Role Function; Social Function: Social Function | |||