All times are listed in CEST (Central European Summer Time)

Found 1 Presentation For Request "1305P"

Poster Display session

1305P - Health-related quality of life (HRQoL) in a phase III study of first-line brigatinib (BRG) vs crizotinib (CRZ) in NSCLC: Updated results from ALTA-1L

Presentation Number
1305P
Speakers
  • Maria Rosario Garcia Campelo (A Coruña, Spain)
Date
17.09.2020

Abstract

Background

Results from the first interim analysis (IA) from ALTA-1L (NCT02737501) showed that BRG has superior efficacy and tolerability with improved HRQoL vs CRZ in patients (pts) with ALK inhibitor–naive ALK+ NSCLC. Specifically, BRG delayed time to deterioration (TTD) and prolonged duration of improvement in global health status/quality of life (GHS/QoL), functional and symptom subscales. Here we report results from the second IA.

Methods

Pts with ALK+ NSCLC were randomized 1:1 to BRG or CRZ as first-line ALK inhibitor therapy. TTD (median time to deterioration, mo) in functional and symptom subscales of EORTC QLQ-C30 were analyzed in the ITT-PRO population (n=131 for each group). Subgroup analyses by baseline brain metastases and prior chemotherapy were conducted, and correlation of best response and TTD in HRQoL was evaluated among BRG pts.

Results

In addition to GHS/QoL (log-rank P=0.0485), BRG significantly delayed TTD versus CRZ for emotional and social functioning, as well as fatigue and GI-related symptoms (nausea and vomiting, appetite loss, and constipation; Table). Among pts with baseline brain metastases (n=38 for each group), BRG significantly delayed TTD for GHS/QoL (median: 16.6 vs 4.7 mo, hazard ratio [HR; 95% CI]: 0.54 [0.29, 1.00]; log-rank P=0.04); BRG also showed numeric improvement vs CRZ in other subgroups (no brain metastases, with/without prior chemotherapy). Among BRG pts, responders (n=100) vs nonresponders (n=31) had longer TTD in GHS/QoL (median: not estimable [NE] vs 7.7 mo, HR [95% CI]: 0.53 [0.28, 1.02]).

TTD in EORTC QLQ-C30 scores, ITT-PRO population

Median TTD, mo HR 95% CI
BRG n=131 CRZ n=131
GHS/QoL 26.7 8.3 0.70 0.49, 1.00
Functioning
Physical NE 10.3 0.67 0.47, 0.97
Role 10.2 6.5 0.84 0.61, 1.17
Emotional NE 10.1 0.56 0.38, 0.81
Cognitive 9.3 4.5 0.75 0.54, 1.02
Social 27.7 4.8 0.59 0.42, 0.85
Symptoms
Fatigue 15.6 4.8 0.67 0.48, 0.93
Nausea and vomiting 12.0 2.8 0.55 0.40, 0.76
Pain 12.1 8.1 0.82 0.59, 1.15
Dyspnea 28.6 16.8 0.98 0.67, 1.43
Insomnia NE 22.1 0.91 0.61, 1.35
Appetite loss NE 9.2 0.62 0.43, 0.90
Constipation 12.0 2.8 0.52 0.38, 0.73
Diarrhea 2.1 2.8 1.00 0.75, 1.34

Conclusions

With longer follow-up, BRG significantly delayed TTD versus CRZ in multiple functional and symptom subscales, consistent with findings from the first IA. Results of subgroup analyses, particularly in the patients with baseline brain metastases, also showed improved HRQoL by BRG. Response to BRG was correlated with delayed TTD in GHS/QoL.

Clinical trial identification

NCT02737501 Release date: March 30, 2016.

Editorial acknowledgement

Professional medical writing assistance was provided by Lauren Gallagher, RPh, PhD, of Peloton Advantage, LLC, an OPEN Health company, Parsippany, NJ, and funded by Millennium Pharmaceuticals, Inc., Cambridge, MA, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited.

Legal entity responsible for the study

ARIAD Pharmaceuticals, Inc., Cambridge, MA, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited.

Funding

ARIAD Pharmaceuticals, Inc., Cambridge, MA, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited.

Disclosure

M.R. Garcia Campelo: Honoraria (self): ARIAD, AstraZeneca, Roche, Pfizer, BMS, Boehringer Ingelheim; Advisory/Consultancy, Speaker Bureau/Expert testimony: ARIAD, AstraZeneca, Roche, Pfizer, BMS, Boehringer Ingelheim. Y. Zhu: Full/Part-time employment: Takeda. H.M. Lin: Full/Part-time employment: Takeda. M. Pérol: Honoraria (self): Roche, Genentech, Eli Lilly, Pfizer, Boehringer Ingelheim, Clovis Oncology, MSD, Bristol-Myers Squibb, Novartis, AstraZeneca, Takeda, Chugai, Amgen; Research grant/Funding (institution): Roche, AstraZeneca, Boehringer Ingelheim, Takeda, Chugai. M. Jahanzeb: Research grant/Funding (institution): Lilly, Boehringer Ingelheim, Callisto, Takeda; Speaker Bureau/Expert testimony: Novartis, Roche Genentech, Pfizer, Takeda, Puma, BMS, AstraZeneca, Merck. S. Popat: Research grant/Funding (institution): Boehringer Ingelheim, Epizyme, BMS, Clovis Oncology, Roche, Lilly, Takeda; Honoraria (self): Boehringer Ingelheim, AstraZeneca, Roche, Takeda, Chugai Pharma; Advisory/Consultancy: Boehringer Ingelheim, Roche, Novartis, Pfizer, AstraZeneca, BMS, MSD, Guardant Health, AbbVie; Travel/Accommodation/Expenses: Boehringer Ingelheim, BMS, Merck Sharp & Dohme. P. Zhang: Full/Part-time employment: Takeda. E. Goodman: Full/Part-time employment: Takeda. D.R. Camidge: Honoraria (self): AstraZeneca, Takeda, Arrys/Kyn, Genoptix, G1 Therapeutics [DSMB], Mersana Therapeutics, Roche/Genentech, Ignyta, Daiichi Sankyo [ILD adjudication committee], Hansoh SRC, Bio-Thera DSMB, Lycera, Revolution Med, Orion, Clovis, Celgene, Novartis; Research grant/Funding (institution): ARIAD/Takeda.

Collapse