Abstract 1347P
Background
The phase II VISION study showed efficacy (ORR by IRC 46.5–50.0%, by investigator 55.6–61.7%) of tepotinib in pts with advanced NSCLC with METex14 skipping, who are typically elderly with poor prognosis. Decline in HRQoL is high in elderly NSCLC pts, highlighting the importance of maintaining HRQoL in these pts. We report HRQoL providing insight on the patient’s perspective, complementing clinician-assessed symptoms.
Methods
VISION Cohort A enrolled pts with EGFR/ALK wild type NSCLC with METex14 skipping and ≤2 lines of prior therapy. Pts received oral tepotinib 500 mg once daily. HRQoL was measured using: EORTC Quality of Life Core 30 (QLQ-C30) and Quality of Life Lung Cancer 13 questionnaire (QLQ-LC13), EuroQol Five-Dimension Five-Level Scale (EQ-5D-5L) questionnaire and Visual Analog Scale (VAS), completed at baseline [BL] and every 6 weeks (predefined analysis at week 12), scored from 0–100 (≥10 points change considered clinically meaningful). Time to deterioration (TTD) was defined as time from BL to first 10 point deterioration using Kaplan-Meier estimates; the proportion of pts without deterioration was estimated every 3 months.
Results
As of 01-Jan-2020, 99 pts had ≥9 months’ follow-up and were analyzed for HRQoL (median age 74 [41-94]). QLQ-LC13 mean scores indicated meaningful improvement in cough (–12.1) and numerical improvement in dyspnea (–3.1) and chest pain (–4.0) at week 12 that were maintained to week ≥24. QLQ-C30 functional and symptom scales and EQ-5D-5L VAS scores were also stable. Median TTD and proportion of pts without deterioration is shown in the table. Table: 1347P
| Median TTD (95% CI); months | Pts without deterioration; % (95%CI) | ||||
| 3 months | 6 months | 9 months | |||
| QLQ-LC13 symptoms | Cough | 19.3 (11.1, ne) | 81 (69, 88) | 78 (66, 86) | 75 (62, 84) |
| Dyspnea | 5.6 (3.3, 11.1) | 65 (53, 75) | 45 (32, 56) | 38 (26, 51) | |
| Chest pain | 24.9 (11.1, ne) | 86 (75, 92) | 71 (58, 80) | 66 (53, 77) | |
| QLQ-C30 Global Health Score | 15.2 (5.6, 33.2) | 77 (65, 85) | 61 (48, 72) | 55 (41, 66) | |
| EQ-5D-5L VAS | 11.1 (5.8, 19.4) | 78 (66, 86) | 60 (47, 71) | 52 (39, 64) |
Conclusions
In pts with advanced NSCLC with METex14 skipping, overall HRQoL was maintained during treatment with tepotinib, with a meaningful improvement of cough and beneficial stabilization of dyspnea and chest pain symptoms. These HRQoL outcomes together with the reported efficacy and safety profile support the use of tepotinib in elderly pts with METex14 skipping NSCLC.
Clinical trial identification
NCT02864992.
Editorial acknowledgement
Medical writing assistance (funded by Merck KGaA, Darmstadt, Germany) was provided by Syneos Health, London, UK.
Legal entity responsible for the study
Merck KGaA, Darmstadt, Germany.
Funding
Merck KGaA, Darmstadt, Germany.
Disclosure
M.C. Garassino: Advisory/Consultancy: Boehringer Ingelheim; Advisory/Consultancy: Novartis; Advisory/Consultancy: Pfizer; Advisory/Consultancy: Seattle Genetics; Advisory/Consultancy: Daiichi Sankyo; Advisory/Consultancy: Sanofi; Speaker Bureau/Expert testimony: Otsuka Pharma; Advisory/Consultancy: Incyte; Advisory/Consultancy, Speaker Bureau/Expert testimony: Eli Lilly; Advisory/Consultancy, Speaker Bureau/Expert testimony: BMS; Advisory/Consultancy, Speaker Bureau/Expert testimony: Roche; Advisory/Consultancy, Speaker Bureau/Expert testimony: Celgene; Advisory/Consultancy, Speaker Bureau/Expert testimony: Takeda; Advisory/Consultancy, Speaker Bureau/Expert testimony, steering committee: MSD; Advisory/Consultancy, Speaker Bureau/Expert testimony, steering committee: AstraZeneca; Honoraria (self), for speaker/advisory role: Takeda. X. Le: Advisory/Consultancy: AstraZeneca; Advisory/Consultancy, Research grant/Funding (self): Eli Lilly; Advisory/Consultancy: EMD Serono; Research grant/Funding (self): Boehringer Ingelheim. D.M. Kowalski: Advisory/Consultancy: Roche/Genentech; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: Boehringer Ingelheim; Advisory/Consultancy: BMS; Advisory/Consultancy: Pfizer; Advisory/Consultancy: MSD. M.R. Migliorino: Advisory/Consultancy, Speaker Bureau/Expert testimony: Roche; Advisory/Consultancy, Speaker Bureau/Expert testimony: AstraZeneca; Advisory/Consultancy, Speaker Bureau/Expert testimony: Boehringer Ingelheim; Advisory/Consultancy, Speaker Bureau/Expert testimony: Pfizer; Advisory/Consultancy, Speaker Bureau/Expert testimony: Takeda; Advisory/Consultancy, Speaker Bureau/Expert testimony: MSD; Advisory/Consultancy, Speaker Bureau/Expert testimony: BMS. J. Fuentes Pradera: Advisory/Consultancy: Roche; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: Boehringer Ingelheim; Advisory/Consultancy: BMS; Advisory/Consultancy: MSD; Advisory/Consultancy: GSK. T. Kato: Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Spouse/Financial dependant, Immediate family member employment: Lilly; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): AstraZeneca; Advisory/Consultancy: MSD; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Chugai Pharma; Honoraria (self), Advisory/Consultancy: Nitto Denko; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): AbbVie; Advisory/Consultancy, Research grant/Funding (institution): Merck Serono; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Pfizer; Honoraria (self): Roche; Honoraria (self): Boehringer Ingelheim; Honoraria (self), Research grant/Funding (institution): Ono Pharmaceutical; Honoraria (self), Research grant/Funding (institution): Taiho Pharmaceutical; Honoraria (self), Research grant/Funding (self): BMS; Honoraria (self), Research grant/Funding (institution): MSD; Honoraria (self), Research grant/Funding (self): Novartis; Honoraria (self): Sumitomo Dainippon Pharma; Honoraria (self): Takeda; Honoraria (self): Merck KGaA; Honoraria (self): Daiichi Sankyo; Honoraria (self): Shionogi; Honoraria (self): Nippon Kayaku; Research grant/Funding (self): Kyorin; Research grant/Funding (self): Regenoron; Research grant/Funding (self), Research grant/Funding (institution): Kyowa Hakko Kirin. M. Thomas: Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses, Honoraria – Scientific Meetings: BMS; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses, Honoraria – Scientific Meetings: MSD; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses, Honoraria – Scientific Meetings: AstraZeneca; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses, Honoraria – Scientific Meetings: Novartis; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses, Honoraria – Scientific Meetings: Roche; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses, Honoraria – Scientific Meetings: Takeda; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses, Honoraria – Scientific Meetings: Lilly; Honoraria (self), Travel/Accommodation/Expenses, Honoraria – Scientific Meetings: Chugai; Honoraria (self), Travel/Accommodation/Expenses, Honoraria – Scientific Meetings: Celgene; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses, Honoraria – Scientific Meetings: Boehringer Ingelheim; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses, Honoraria – Scientific Meetings: Pfizer. E.F. Smit: Advisory/Consultancy: Lilly; Advisory/Consultancy, Research grant/Funding (institution): AstraZeneca; Advisory/Consultancy, Research grant/Funding (institution): Boehringer Ingelheim; Advisory/Consultancy, Research grant/Funding (institution): Roche/Genentech; Advisory/Consultancy, Research grant/Funding (institution): BMS; Advisory/Consultancy: Merck KGaA; Advisory/Consultancy: MSD Oncology; Advisory/Consultancy: Takeda; Advisory/Consultancy, Research grant/Funding (institution): Bayer; Advisory/Consultancy: Pfizer; Advisory/Consultancy: MSD; Advisory/Consultancy: BMS; Advisory/Consultancy: Celgene; Advisory/Consultancy: Takeda; Advisory/Consultancy: AbbVie; Advisory/Consultancy: Novartis; Advisory/Consultancy: Bayer; Advisory/Consultancy: Regeneron; Advisory/Consultancy: Daiichi Sankyo; Advisory/Consultancy: Seattle Genetics. M. Gottfried: Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: Boehringer Ingelheim; Advisory/Consultancy: Roche/Genentech; Advisory/Consultancy: BMS; Advisory/Consultancy: MSD Oncology; Advisory/Consultancy: Takeda; Advisory/Consultancy: AbbVie; Advisory/Consultancy: Novartis. C. Britschgi: Advisory/Consultancy, Travel/Accommodation/Expenses: AstraZeneca; Advisory/Consultancy: Pfizer; Advisory/Consultancy: Roche; Advisory/Consultancy, Travel/Accommodation/Expenses: Takeda; Advisory/Consultancy: Janssen-Cilag; Advisory/Consultancy: Boehringer Ingelheim. A. Johne, J. Scheele, R. Bruns, H. Vioix, B. Pfeiffer: Full/Part-time employment: Merck KGaA, Darmstadt, Germany. P.K. Paik: Advisory/Consultancy: AbbVie; Advisory/Consultancy: BMS; Advisory/Consultancy: Calithera; Advisory/Consultancy, Research grant/Funding (institution): Celgene; Advisory/Consultancy: Lilly; Advisory/Consultancy: Takeda; Research grant/Funding (self), Research grant/Funding (institution): EMD Serono. All other authors have declared no conflicts of interest.