4638 - Health-Related Quality of Life (HRQoL) Impact of Pembrolizumab (P) Versus Chemotherapy (C) as First-Line (1L) Treatment in PD-L1–Positive Advanced Gastric or Gastroesophageal Junction (G/GEJ) Adenocarcinoma

Background

KEYNOTE-062 (NCT02494583) was a randomized, active-controlled, phase III clinical trial of 1L P or P+C versus C in patients with HER2–negative, advanced G/GEJ with PD-L1 combined positive score (CPS) ≥1. P showed noninferiority to C for overall survival (OS) in CPS ≥1 and clinically meaningful improvement for OS in CPS ≥10. We present results of prespecified HRQoL analyses for P versus C in the population with CPS ≥1.

Methods

The EORTC QLQ-C30 and EORTC QLQ-STO22 were administered at baseline, weeks 3, 6, 9, and 12, and every 6 weeks thereafter up to 1 year or end of treatment, whichever came first, and the 30-day posttreatment discontinuation follow-up visit. Data from patients receiving ≥1 dose of study treatment and completing ≥1 HRQoL assessment were analyzed. Least square mean (LSM) score change from baseline to prespecified week 18, 95% CI, and nominal P values were calculated. Time to deterioration (TTD) (≥10-point decline from baseline) was assessed by Kaplan-Meier method and Cox regression model. HRs, 95% CIs, and nominal P values are provided.

Results

The HRQoL population included 495 patients with PD-L1 CPS ≥1 (P, n = 252; C, n = 243). Compliance at week 18 was similar in both P and C arms for QLQ-C30 (87.9% and 81.9%, respectively) and QLC-STO22 (87.9% and 81.3%, respectively). There was no significant difference in LSM score change from baseline to week 18 between arms (–0.16; 95% CI, –5.01 to 4.69; P = 0.948) in global health status (GHS)/QoL. The LSM score change from baseline to week 18 for most QLQ-C30 and QLQ-STO22 subscales/items showed comparable but not statistically significant worsening in both treatment arms. TTD for GHS/QoL (HR, 0.96; 95% CI, 0.67-1.38; P = 0.826), appetite loss subscale in QLQ-C30 (HR, 0.83; 95% CI, 0.58-1.20; P = 0.314), and pain subscale in QLQ-STO22 (HR, 1.22; 95% CI, 0.78-1.91; P = 0.381) were similar between arms. Significantly longer TTD was observed for P than for C for the nausea/vomiting subscale in QLQ-C30 (HR, 0.61; 95% CI, 0.44-0.85; P = 0.003).

Conclusions

HRQoL was similar between P and C in 1L treatment in patients with advanced G/GEJ adenocarcinoma with CPS ≥1.

Clinical trial identification

NCT02494583; July 10, 2015.

Editorial acknowledgement

Medical writing and/or editorial assistance was provided by Amy McQuay, PhD, of the ApotheCom pembrolizumab team (Yardley, PA, USA) and funded by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

Legal entity responsible for the study

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA (MSD).

Funding

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA

Disclosure

E. Van Cutsem: Advisory / Consultancy: Astellas, Astrazeneca, Bayer, Bristol-Myers Squibb, Celgene, Incyte, Lilly, Merck Sharp & Dohme, Merck KGaA, Novartis, Roche, Servier; Research grant / Funding (institution): Amgen, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Ipsen, Lilly, Roche, Merck Sharp & Dohme, Merck KGaA, Novartis, Roche, Servier. A. Valderrama: Full / Part-time employment: Merck & Co., Inc.. Y. Bang: Advisory / Consultancy: AstraZeneca, Novartis, Genentech/Roche, MSD, Merck Serano , Bayer, BMS, Eli Lilly, Taiho, Daiich-Sankyo, Astellas, BeiGene, GreenCross, Samyang Biopharm, Hanmi, Genexine; Research grant / Funding (institution): AstraZeneca, Novartis, Genentech/Roche, MSD, Merck Serano, Bayer, BMS, GSK, Pfizer, Eli Lilly, Boehringer-Ingelheim, MacroGenics, Boston Biomedical, FivePrime, Curis, Taiho, Takeda, Ono, Daiichi Sankyo, Astellas, BeiGene, Green Cross, CKD Pharma, Genexi. C. Fuchs: Advisory / Consultancy: Agios, Bain Capital, Bayer, Celgene, Dicerna, Five Prime Therapeutics, Gilead Sciences, Eli Lilly, Genentech, KEW, Merck, Merrimack Pharmaceuticals, Pfizer, Sanofi, Taiho, and Unum Therapeutics; Leadership role, Shareholder / Stockholder / Stock options, Director for CytomX; unexercised stock options: CytomX Therapeutics; Advisory / Consultancy, Shareholder / Stockholder / Stock options, unexercised stock options : Entrinsic Health. K. Shitara: Honoraria (self): Novartis; Honoraria (self): AbbVie; Honoraria (self): Yakult; Advisory / Consultancy, Research grant / Funding (institution): Astellas Pharma; Advisory / Consultancy, Research grant / Funding (institution): Lilly; Advisory / Consultancy: Bristol-Myers Squibb; Advisory / Consultancy: Takeda; Advisory / Consultancy: Pfizer; Advisory / Consultancy, Research grant / Funding (institution): Ono Pharmaceutical; Advisory / Consultancy, Research grant / Funding (institution): MSD; Research grant / Funding (institution): Dainippon Sumitomo Pharma; Research grant / Funding (institution): Daiichi Sankyo; Research grant / Funding (institution): Taiho Pharmaceutical; Research grant / Funding (institution): Chugai Pharma; Research grant / Funding (institution): MediScience. Y.Y. Janjigian: Advisory / Consultancy: Eli Lilly; Advisory / Consultancy: Michael J Hennessey; Advisory / Consultancy: Jounce Therapeutics; Advisory / Consultancy: Daiichi Sankyo; Advisory / Consultancy: ONO Pharma; Advisory / Consultancy: Merck & Co., Inc.; Advisory / Consultancy: Bristol-Myers Squibb. V. Shankaran: Research grant / Funding (institution): BMS; Research grant / Funding (institution): Merck; Research grant / Funding (institution): AstraZeneca; Research grant / Funding (institution): Bayer. S. Stein: Advisory / Consultancy: Merck; Advisory / Consultancy: Bayer; Advisory / Consultancy: BMS; Advisory / Consultancy: Genentech; Advisory / Consultancy: Exelixis; Advisory / Consultancy: QED. J.M. Norquist: Shareholder / Stockholder / Stock options, Full / Part-time employment: Merck & Co., Inc.. U. Kher: Shareholder / Stockholder / Stock options, Full / Part-time employment: Merck & Co., Inc.. S. Shah: Shareholder / Stockholder / Stock options, Full / Part-time employment: Merck & Co., Inc.. M. Alsina: Honoraria (self), Travel / Accommodation / Expenses: Amgen; Honoraria (self), Advisory / Consultancy: Bristol-Myers Squibb; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Lilly; Honoraria (self), Advisory / Consultancy: Merck Sharp and Dohme; Honoraria (self), Travel / Accommodation / Expenses: Roche; Honoraria (self), Advisory / Consultancy: Servier. All other authors have declared no conflicts of interest.