Abstract 4653
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.
Resources from the same session
1902 - Phase II trial of preoperative modified FOLFIRINOX (mFOLFIRINOX) followed by postoperative gemcitabine (GEM) in patients (pts) with borderline resectable (BR) and locally advanced (LA) pancreatic ductal adenocarcinoma (PDAC)
Presenter: Jae Ho Jeong
Session: Poster Display session 2
Resources:
Abstract
3716 - Prognostic factors for predicting early recurrence within the first year of surgery in pancreatic ductal adenocarcinoma
Presenter: Naru Kim
Session: Poster Display session 2
Resources:
Abstract
3947 - Integrated population pharmacokinetic modelling of liposomal irinotecan in patients with various tumour types, including untreated metastatic pancreatic cancer (mPC)
Presenter: Teresa Macarulla
Session: Poster Display session 2
Resources:
Abstract
2880 - Expression of long noncoding RNA and clinical outcomes of pancreatic cancer patients who received adjuvant chemotherapy by S-1 or GEM after curative resection.
Presenter: Mariko Kamiya
Session: Poster Display session 2
Resources:
Abstract
5029 - POLO: Time to treatment discontinuation and subsequent therapies following maintenance olaparib for patients (pts) with a germline BRCA mutation and metastatic pancreatic cancer (mPC)
Presenter: Eric Van Cutsem
Session: Poster Display session 2
Resources:
Abstract
4730 - Diagnostic Value of Digital Multiplexed Detection of Single Nucleotide Variants in Pancreatic Cancer Specimens Collected by Endoscopic Ultrasound Fine-Needle Aspiration
Presenter: Irina Cazacu
Session: Poster Display session 2
Resources:
Abstract
3303 - Phase I/II study of LDE225 in combination with gemcitabine and nab-paclitaxel in patients with metastatic pancreatic cancer
Presenter: Esther Pijnappel
Session: Poster Display session 2
Resources:
Abstract
2009 - Efficacy of platinum-containing chemotherapy and prognosis of pancreatic cancer patients with homologous recombination deficiency: meta-analysis of published clinical studies
Presenter: Elizeveta Polyanskaya
Session: Poster Display session 2
Resources:
Abstract
2164 - Plasmatic CXCL8 is a marker for TGFß-activated kinase 1 (TAK1) activation which may predict resistance to nanoliposomal irinotecan (nal-IRI) in gemcitabine-refractory pancreatic cancer (PC) patients
Presenter: Valeria Merz
Session: Poster Display session 2
Resources:
Abstract
2529 - A protein level signature of four selected genes associated with survival outcomes of patients with pancreatic ductal adenocarcinoma
Presenter: Jie Hua
Session: Poster Display session 2
Resources:
Abstract