2886 - Health-related quality of life (HRQoL) for pembrolizumab or placebo plus carboplatin and paclitaxel or nab-paclitaxel in patients with metastatic squamous NSCLC: data from KEYNOTE-407

Background

In the randomized, double-blind, phase 3 KEYNOTE-407 study, pembrolizumab (pembro) plus carboplatin and paclitaxel or nab-paclitaxel improved OS, PFS, and ORR and had a manageable safety profile compared with placebo (pbo) plus carboplatin and paclitaxel or nab-paclitaxel as first-line therapy for patients with metastatic squamous NSCLC. Patient-reported outcomes (PROs) were a prespecified exploratory endpoint of KEYNOTE-407 (NCT02775435).

Methods

559 patients with previously untreated stage IV squamous NSCLC, ECOG PS 0–1, and measurable disease per RECIST v1.1 were randomized 1:1 to receive 4 cycles of pembro 200 mg Q3W or pbo Q3W plus carboplatin AUC 6 and paclitaxel 200 mg/m² Q3W or nab-paclitaxel 100 mg/m² QW, followed by pembro or pbo monotherapy for up to 35 cycles total. The EORTC QLQ-C30 and QLQ-LC13 were administered at cycles 1–7, then every 3 cycles up to week 48. Prespecified key PROs were change from baseline to weeks 9 and 18 in the QLQ-C30 global health status (GHS)/quality of life (QoL) score and time to 10-point deterioration in the composite endpoint of cough, chest pain, or dyspnea. P values are 2-sided and nominal.

Results

PRO analyses included 554 and 553 patients who completed ≥1 QLQ-C30 or ≥1 QLQ-LC13 assessment, respectively, and received ≥1 administration of study treatment. Compliance rates were similar between the groups and instruments (baseline, ~93%–94%; week 9, ~84%; week 18, ~87%). Mean QLQ-C30 GHS/QoL baseline scores were 63.9 in the pembro combination group and 62.7 in the pbo combination group. At weeks 9 and 18, the mean score for QLQ-C30 GHS/QoL improved from baseline in the pembro combination group and decreased in the pbo combination group (least squares mean difference between groups: week 9, 3.6 points [95% CI, 0.3–6.9], P=0.0337; week 18, 4.9 points [95% CI, 1.4–8.3], P=0.0060). Median time to deterioration in the composite endpoint of cough, chest pain, or dyspnea was not reached in either group (HR, 0.79 [95% CI, 0.58–1.06]; P=0.125).

Conclusions

Addition of pembro to chemotherapy maintained or improved HRQoL measurements over chemotherapy alone, supporting its use as first-line therapy for metastatic squamous NSCLC.

Clinical trial identification

ClinicalTrials.gov number NCT02775435, originally posted May 17, 2016

Editorial Acknowledgement

Medical writing and editorial assistance was provided by C4 MedSolutions, LLC (Yardley, PA), a CHC Group company. This assistance was funded by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.