164O - Health-Related Quality of Life (HRQoL) With Pembrolizumab (pembro) + Chemotherapy (chemo) vs Placebo (pbo) + Chemo as 1L Treatment for Advanced Triple-Negative Breast Cancer (TNBC): Results From KEYNOTE-355

Background

KEYNOTE-355 (NCT02819518) evaluated pembro + chemo vs pbo + chemo in previously untreated patients (pts) with locally recurrent inoperable or metastatic TNBC. Pembro + chemo improved the PFS and OS in pts with PD-L1 combined positive score (CPS) ≥10 disease. We present results for patient-reported outcome (PRO) measures among pts with PD-L1 CPS ≥10.

Methods

Pts were randomized 2:1 to pembro 200 mg or pbo Q3W for up to 35 cycles + chemo (investigator’s choice of nab-paclitaxel, paclitaxel, or gemcitabine/carboplatin). QLQ-C30 (including global health status/quality of life [GHS/QoL]) and physical and emotional functioning scales), QLQ-BR23, and EQ-5D visual analogue scale (VAS) were prespecified. PROs were assessed at baseline, during treatment, and the 30-day safety follow-up visit and analyzed for pts who received ≥1 dose of study treatment and completed ≥1 PRO assessment. Change in PRO scores from baseline were assessed at wk 15 (latest timepoint at which completion/compliance rates were ≥60%/≥80%; negative values favor the pembrolizumab group). Time to deterioration (TTD) in PROs was defined as time to first onset of ≥10-point worsening in score from baseline.

Results

These PRO analyses included 317 pts with PD-L1 CPS ≥10 (pembro + chemo; n = 217; pbo + chemo, n = 100). Completion/compliance at wk 15 was 77.0%/87.0% with pembro + chemo and 70.0%/81.4% with pbo + chemo. There were no between-group differences in change from baseline to wk 15 in the QLQ-C30 GHS/QoL, emotional functioning, physical functioning, or the EQ-5D VAS scale scores, and no between-group difference in TTD in QLQ-C30 GHS/QoL, emotional functioning, or physical functioning (Table). Analyses by QLQ-BR23 showed no decrease in HRQoL with pembro + chemo vs pbo + chemo. Table: 164O

aBased on constrained longitudinal data analysis model (two-sided P value).

bBased on stratified Cox regression model; P value based on stratified log-rank test (one-sided).

Conclusions

Addition of pembro to chemo did not result in a decrease in HRQoL in pts with previously untreated, PD-L1–positive (CPS ≥10) advanced, TNBC.

Clinical trial identification

NCT02819518, EudraCT 2016-001432-35.

Editorial acknowledgement

Additional support was provided by Wilbur Panof Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. Medical writing assistance was provided by Kara Nyberg, PhD, of ICON plc (Blue Bell, PA, USA). This assistance was 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.

Funding

Merck Sharp & Dohme Corp.

Disclosure

D.W. Cescon: Financial Interests, Personal, Consultancy/Advisory role: AstraZeneca, Exact Sciences, Eisai, Gilead, GlaxoSmithKline, Merck, Novartis, Pfizer Roche; Financial Interests, Institutional, Research Funding: GlaxoSmithKline, Inivata, Merck, Pfizer, Roche; Other: is a member of a trial steering committee for AstraZeneca, Merck and GlaxoSmithKline; Other: holds a holds a patent (US62/675,228) for methods of treating cancers characterized by a high expression level of spindle and kinetochore associated complex subunit 3 (ska3) gene. P. Schmid: Financial Interests, Personal, Advisory Board: AstraZeneca, Bayer, Boehringer Ingelheim, Merck, Novartis, Pfizer, Puma, Roche, Daiichi Sankyo; Financial Interests, Institutional, Research Grant: Astellas, AstraZeneca, Genentech, Novartis, Oncogenex, Roche; Other, Spouse - Employee: Roche. H.S. Rugo: Financial Interests, Personal, Invited Speaker: Puma; Financial Interests, Personal, Advisory Board: Samsung; Financial Interests, Personal, Invited Speaker: Mylan; Financial Interests, Institutional, Invited Speaker: Novartis; Financial Interests, Institutional, Invited Speaker: Lilly; Financial Interests, Institutional, Invited Speaker: Pfizer; Financial Interests, Institutional, Invited Speaker: OBI Pharma; Financial Interests, Institutional, Invited Speaker: Immunomedics; Financial Interests, Institutional, Invited Speaker: Macrogenics; Financial Interests, Institutional, Invited Speaker: Daiichi; Financial Interests, Institutional, Invited Speaker: AstraZeneca; Financial Interests, Institutional, Invited Speaker: Roche; Financial Interests, Institutional, Invited Speaker: Merck; Financial Interests, Institutional, Invited Speaker: Odonate; Financial Interests, Institutional, Invited Speaker: Sermonix; Financial Interests, Institutional, Invited Speaker: Seattle Genetics; Financial Interests, Institutional, Invited Speaker: Polyphor; Financial Interests, Institutional, Invited Speaker: Boehringer Ingelheim; Non-Financial Interests, Advisory Role, I advise a number of companies without compensation: various. S-A. Im: Financial Interests, Personal, Consulting/Advisory role: Amgen, AstraZeneca, Eisai, Hanmi, Lilly, Medpacto, Inc., Novartis, Pfizer, Roche/Genentech; Financial Interests, Personal, Research Funding: AstraZeneca, Pfizer, Roche/Genentech; Financial Interests, Personal, Other, Travel, accommodations, expenses: Novartis; Roche/Genentech; Financial Interests, Personal, Other: Roche. M. Md Yusof: Financial Interests, Personal, Honoraria: AstraZeneca, Bayer, Boehringer Ingelheim, Merck, MSD, Specialised Therapeutics, Zuellig Pharma, Novartis, Pfizer, Roche, Eisai, Celgene; Financial Interests, Institutional, Research grant: Astellas, AstraZeneca, Arcus, Genentech, Mundi Pharma, Novartis, Pfizer, Roche. C.E. Gallardo: Financial Interests, Personal, Consulting/Advisory role: Lilly, MSD, Roche; Financial Interests, Personal, Speakers Bureau: Bristol Myers Squibb; Financial Interests, Personal, Research Funding: Novartis Pharma SAS, Roche; Financial Interests, Personal, Other, Travel, accommodations, expenses: MSD, Roche. C.H. Barrios: Financial Interests, Personal, Consulting/Advisory role: Boehringer Ingelheim, Eisai Europe Ltd., GlaxoSmithKline, Novartis Pharma SAS, Pfizer Pharmaceuticals Israel, Roche/Genentech; Financial Interests, Personal, Research Funding: AB Science, Abraxis BioScience, Amgen, Asana Biosciences, Astellas Pharma, AstraZeneca, Biomarin, Boehringer Ingelheim, Bristol Myers Squibb, Daiichi Sankyo, Exelixis, GlaxoSmithKline, ImClone Systems, Investigator in AbbVie-sponsored cl. Trials, LEO Pharma, Lilly, Medivation, Merck, Merrimack, Millennium, Mylan, Novartis Pharma SAS, Pfizer Pharmaceuticals Israel, Roche/Genentech, Sanofi, Taiho Pharmaceutical. J.M. 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A. Haiderali, Z. Guo, A. Martin Nguyen: Financial Interests, Personal, Full or part-time Employment: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.; Financial Interests, Personal, Ownership Interest, Stock and Other Ownership Interests: Merck & Co., Inc. X. Zhou: Financial Interests, Personal, Full or part-time Employment: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. J. 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All other authors have declared no conflicts of interest.