4653 - Impact of Pembrolizumab (pembro) Versus Paclitaxel on Health-Related Quality of Life (HRQoL) in Patients With Advanced Gastric or Gastroesophageal Junction (GEJ) Cancer That Has Progressed After First-Line Chemotherapy (KEYNOTE-061)

Background

KEYNOTE-061 (NCT02370498), an open-label, randomized, phase 3 trial of second-line chemotherapy for advanced gastric or GEJ cancer, evaluated IV pembro 200 mg Q3W for up to 2 years vs standard-dose paclitaxel. In the primary analysis population (PD-L1 CPS>1), OS and PFS were not significantly different with pembro vs paclitaxel. We present results of prespecified HRQoL analyses in this population.

Methods

The EORTC QLQ-C30 and QLQ-STO22 were completed at baseline, various time points during treatment cycles up to 1 year or until end of treatment, and 30-day safety follow-up visit. Data were analyzed from patients receiving ≥1 dose of study treatment and completing ≥1 HRQoL assessment. Least-squares mean (LSM) change from baseline to prespecified week 12, 95% CIs, and nominal P values were calculated. Time to deterioration (TTD; ≥10-point decrease from baseline) was assessed by Kaplan-Meier method and Cox regression model. Multiplicity was not controlled for hypotheses testing.

Results

The HRQoL population included 371 subjects with PD-L1 CPS>1 (pembro, n = 188; paclitaxel, n = 183). Compliance for QLQ-C30 and QLQ-STO22 at week 12 was similar in both arms (86.6% and 82.1%, respectively). There was no significant difference in LSM between arms (–3.54; 95% CI, –8.92 to 1.84; P = 0.196) in global health status (GHS)/QoL. At week 18, GHS/QoL scores showed consistent improvement in patients receiving pembro compared to those receiving paclitaxel. The LSM change from baseline to week 12 for most QLQ-C30 and QLQ-STO22 subscales/items showed some worsening of QoL and were similar between arms. TTD for GHS/QoL (HR, 1.06; 95% CI, 0.71-1.58; P = 0.597), nausea/vomiting (HR, 0.81; 95% CI, 0.50-1.33; P = 0.204), appetite loss (HR, 1.22; 95% CI 0.76-1.96; P = 0.782) subscales in QLQ-C30, and pain (HR, 1.09; 95% CI, 0.65-1.83; P = 0.619) subscales in QLQ-STO22 were similar between arms.

Conclusions

In this advanced gastric and GEJ cancer population receiving second-line treatment, HRQoL was similar in patients receiving pembro and those receiving paclitaxel.

Clinical trial identification

NCT02370498, February 25, 2015.

Editorial acknowledgement

Amy McQuay, PhD, of the ApotheCom pembrolizumab team (Yardley, PA, USA), 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, U.S.A. (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. M. Amonkar: Shareholder / Stockholder / Stock options, Full / Part-time employment: Merck & Co., Inc. C.S. Fuchs: Advisory / Consultancy: Agios; Advisory / Consultancy: Bain Capital; Advisory / Consultancy: Bayer; Advisory / Consultancy: Celgene; Advisory / Consultancy, Shareholder / Stockholder / Stock options, Officer / Board of Directors, unexercised stock options: CytomX; Advisory / Consultancy: Dicerna; Advisory / Consultancy: Eli Lilly; Advisory / Consultancy, Shareholder / Stockholder / Stock options, unexercised stock options: Entrinsic Health; Advisory / Consultancy: Five Prime Therapeutics; Advisory / Consultancy: Genentech; Advisory / Consultancy: Gilead Sciences; Advisory / Consultancy: KEW; Advisory / Consultancy: Merck; Advisory / Consultancy: Merrimack; Advisory / Consultancy: Pfizer; Advisory / Consultancy: Roche; Advisory / Consultancy: Sanofi; Honoraria (institution): Taiho; Advisory / Consultancy: Unum. M. Alsina: Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Servier; Honoraria (self), Advisory / Consultancy: BMS; Honoraria (self), Advisory / Consultancy: MSD; Honoraria (self), Travel / Accommodation / Expenses: Roche; Honoraria (self), Travel / Accommodation / Expenses: Lilly; Honoraria (self), Travel / Accommodation / Expenses: Amgen; Research grant / Funding (institution): Merck. M. Özgüroğlu: Honoraria (self): Novartis; Honoraria (self): Roche; Honoraria (self), Advisory / Consultancy: Sanofi; Honoraria (self), Advisory / Consultancy: Astellas; Travel / Accommodation / Expenses: BMS; Honoraria (institution), Advisory / Consultancy, Travel / Accommodation / Expenses: Janssen. 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, Boeringer-Ingelheim, MacroGenics, Boston Biomedical, FivePrime, Curis, Taiho, Takeda, Ono, Daiichi Sankyo, Astellas, BeiGene, Green Cross, CKD Pharma, Genexi. H.C. Chung: Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Merck-Serono; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Lilly; Honoraria (self): Foundation Medicine; Advisory / Consultancy, Research grant / Funding (institution): Taiho; Advisory / Consultancy: Celltrion; Advisory / Consultancy, Research grant / Funding (institution): MSD; Advisory / Consultancy: Quintiles; Advisory / Consultancy: BMS; Research grant / Funding (institution): GSK; Research grant / Funding (institution): BMS-ONO. K. Muro: Honoraria (self): Takeda; Honoraria (self): Chugai Pharma; Honoraria (self): Yakult Honsha; Honoraria (self), Research grant / Funding (institution): Merck Serono; Honoraria (self): Taiho Pharmaceutical; Honoraria (self): Lilly; Honoraria (self), Research grant / Funding (institution): Ono Pharmaceutical; Honoraria (self): Bayer; Research grant / Funding (institution): MSD; Research grant / Funding (institution): Daiichi Sankyo; Research grant / Funding (institution): Shionogi; Research grant / Funding (institution): Kyowa Hakko Kirin; Research grant / Funding (institution): Gilead Sciences; Research grant / Funding (institution): Pfizer; Research grant / Funding (institution): Sanofi. E. Goekkurt: Advisory / Consultancy: MSD; Advisory / Consultancy: BMS; Advisory / Consultancy: Roche; Advisory / Consultancy: Sanofi; Advisory / Consultancy: Merck; Travel / Accommodation / Expenses: Servier. A. Benson: Advisory / Consultancy: Bristol-Myers Squibb, Eli Lilly & Company, Guardant Health, Exelixis, Purdue Pharma, inVentive Health Inc., Axio, Genentech, Bayer, Merck, Rafael Pharmaceuticals, Astellas (Data Monitoring Committee member), Terumo, Taiho, Thera Bionic, LSK, Axio (Data Mo; Research grant / Funding (self): Acerta, Celgene, Advanced Accelerator Applications, Novartis, Infinity Pharmaceuticals (Data Monitoring Committee), Merck Sharp and Dohme, Taiho, Bristol-Myers Squibb, Medimmune/AstraZeneca, Xencor, Bristol-Myers Squibb (Data Monitoring Committee), PreECO. W. Sun: Advisory / Consultancy: Bayer; Speaker Bureau / Expert testimony: Taiho; Research grant / Funding (self): Merck. Z.A. Wainberg: Advisory / Consultancy: Sirtex Medical; Advisory / Consultancy: Array BioPharma; Advisory / Consultancy, Research grant / Funding (institution): Five Prime Therapeutics; Advisory / Consultancy, Research grant / Funding (institution): Novartis; Advisory / Consultancy: Lilly; Advisory / Consultancy, Research grant / Funding (institution): Merck; Advisory / Consultancy: Merck KGaA; Advisory / Consultancy: Bristol-Myers Squibb; Advisory / Consultancy: Aduro Biotech; Advisory / Consultancy, Travel / Accommodation / Expenses: Genentech; Research grant / Funding (institution): Plexxikon; Research grant / Funding (institution): Pfizer. J. Norquist: Full / Part-time employment: Merck & Co., Inc. X. Chen: Shareholder / Stockholder / Stock options, Full / Part-time employment: Merck & Co., Inc. C. Shih: Full / Part-time employment: Merck & Co., Inc. 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): Medi Science.