TY - JOUR
T1 - Patient-reported outcomes in capmatinib-treated patients with METex14-mutated advanced NSCLC
T2 - Results from the GEOMETRY mono-1 study
AU - Wolf, Jürgen
AU - Garon, Edward B.
AU - Groen, Harry J.M.
AU - Tan, Daniel S.W.
AU - Gilloteau, Isabelle
AU - Le Mouhaer, Sylvie
AU - Hampe, Marcio
AU - Cai, Can
AU - Chassot-Agostinho, Andrea
AU - Reynolds, Maria
AU - Sherif, Bintu
AU - Heist, Rebecca S.
N1 - Funding Information:
Capmatinib was originally developed by Incyte and was in-licensed by Novartis as of 24 November 2009. Medical writing assistance was provided by Emma Richards-Sirianni, PhD, and Egle McDonald, PhD, of Novartis UK Ltd. and was funded by Novartis Pharmaceuticals in accordance with Good Publication Practice (GPP3) guidelines ( http://www.ismpp.org/gpp3 ). We are also grateful for the support of all those involved in the execution of this study.
Funding Information:
This study was supported by Novartis Pharmaceuticals .
Funding Information:
This study was supported by Novartis Pharmaceuticals.Capmatinib was originally developed by Incyte and was in-licensed by Novartis as of 24 November 2009. Medical writing assistance was provided by Emma Richards-Sirianni, PhD, and Egle McDonald, PhD, of Novartis UK Ltd. and was funded by Novartis Pharmaceuticals in accordance with Good Publication Practice (GPP3) guidelines (http://www.ismpp.org/gpp3). We are also grateful for the support of all those involved in the execution of this study.
Publisher Copyright:
© 2022
PY - 2023/4
Y1 - 2023/4
N2 - Introduction: Capmatinib, a MET inhibitor, showed substantial antitumour activity with manageable side effects in patients with MET exon 14 (METex14)-mutated advanced non-small cell lung cancer (aNSCLC) in the GEOMETRY mono-1 study. We report patient-reported outcomes (PROs) from this study. Methods: Enrolled treatment-naïve (1L) or pre-treated (2L+) patients with aNSCLC with a METex14-skipping mutation received 400 mg capmatinib twice daily during 21-day treatment cycles. PROs were collected at baseline and every six weeks thereafter using EORTC QLQ-C30 global health status/quality of life (GHS/QoL), QLQ-LC13 symptoms, and EQ-5D-5L visual analogue scale (VAS) questionnaires. Results: As of 6 January 2020, 27/28 1L and 65/69 2L+ patients had completed PROs at baseline; compliance rates remained >70%. Cough improved early, with meaningful improvements (≥10-point change from baseline) observed throughout cycles (mean change from baseline [SD] by week 7: 1L −13.0 [39.9], 2L+ −8.2 [28.4]; week 43: 1L −28.2 [26.7], 2L+ −10.5 [27.3]). QoL, assessed by GHS/QoL and VAS, improved by week 7 in 1L and 2L+ patients, with improvements generally sustained over time. Median time to definitive deterioration (TTDD) in GHS/QoL was 16.6 months (95% CI: 9.7, not estimable [NE]) in 1L and 12.4 months (95% CI: 4.2, 19.4) in 2L+ patients. Median TTDD for dyspnoea was 19.4 months (95% CI: 12.4, NE) and 22.1 months (95% CI: 9.9, NE) for 1L and 2L+ patients, respectively, and NE for cough and chest pain. Conclusions: Capmatinib was associated with clinically meaningful improvements in cough and preserved QoL, further supporting its use in patients with METex14-mutated aNSCLC. Trial registration: ClinicalTrials.gov registry number: NCT02414139.
AB - Introduction: Capmatinib, a MET inhibitor, showed substantial antitumour activity with manageable side effects in patients with MET exon 14 (METex14)-mutated advanced non-small cell lung cancer (aNSCLC) in the GEOMETRY mono-1 study. We report patient-reported outcomes (PROs) from this study. Methods: Enrolled treatment-naïve (1L) or pre-treated (2L+) patients with aNSCLC with a METex14-skipping mutation received 400 mg capmatinib twice daily during 21-day treatment cycles. PROs were collected at baseline and every six weeks thereafter using EORTC QLQ-C30 global health status/quality of life (GHS/QoL), QLQ-LC13 symptoms, and EQ-5D-5L visual analogue scale (VAS) questionnaires. Results: As of 6 January 2020, 27/28 1L and 65/69 2L+ patients had completed PROs at baseline; compliance rates remained >70%. Cough improved early, with meaningful improvements (≥10-point change from baseline) observed throughout cycles (mean change from baseline [SD] by week 7: 1L −13.0 [39.9], 2L+ −8.2 [28.4]; week 43: 1L −28.2 [26.7], 2L+ −10.5 [27.3]). QoL, assessed by GHS/QoL and VAS, improved by week 7 in 1L and 2L+ patients, with improvements generally sustained over time. Median time to definitive deterioration (TTDD) in GHS/QoL was 16.6 months (95% CI: 9.7, not estimable [NE]) in 1L and 12.4 months (95% CI: 4.2, 19.4) in 2L+ patients. Median TTDD for dyspnoea was 19.4 months (95% CI: 12.4, NE) and 22.1 months (95% CI: 9.9, NE) for 1L and 2L+ patients, respectively, and NE for cough and chest pain. Conclusions: Capmatinib was associated with clinically meaningful improvements in cough and preserved QoL, further supporting its use in patients with METex14-mutated aNSCLC. Trial registration: ClinicalTrials.gov registry number: NCT02414139.
KW - Capmatinib
KW - GEOMETRY mono-1
KW - METex14-mutated
KW - Non-small cell lung cancer
KW - Patient-reported outcomes
U2 - 10.1016/j.ejca.2022.10.030
DO - 10.1016/j.ejca.2022.10.030
M3 - Article
C2 - 36822130
AN - SCOPUS:85149903906
SN - 0959-8049
VL - 183
SP - 98
EP - 108
JO - European Journal of Cancer
JF - European Journal of Cancer
ER -