Health-related quality of life among patients with relapsed/refractory classical hodgkin lymphoma (r/r chl) in a phase 3 study of pembrolizumab versus brentuximab vedotin

Introduction: In the open-label, international, randomized, phase 3 KEYNOTE-204 study (NCT02684292), the PD-1 inhibitor pembrolizumab (pembro) improved progression-free survival vs brentuximab vedotin (BV) in patients (pts) with R/R cHL who were ineligible for or failed autologous stem cell transplant (ASCT). Here we report analyses of exploratory end points of pembro vs BV on health-related quality of life (HRQoL) among R/R cHL pts from KEYNOTE-204. Methods: Pts were randomized (1:1) to pembro 200 mg IV or BV 1.8 mg/kg IV Q3W. PRO analysis population included pts who received ≥1 dose of study treatment and completed ≥1 PRO assessment. European Organization for Research and Treatment of Cancer (EORTC) QoL Questionnaire Core 30 (QLQ-C30) was administered at baseline, Q6W until wk 24, and Q12W thereafter. Prespecified exploratory end points included least square mean (LSM) change from baseline to wk 24 and time to deterioration (TTD; ≥10-point decline from baseline) for global health status/QoL (GHS/QoL), functioning scales (physical, role, emotional, cognitive, and social), symptom scales (fatigue, nausea/vomiting, pain), and symptom single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). Differences between groups were evaluated using two-sided nominal P values not controlled for multiplicity. Conclusions: Pembro improved pt HRQoL compared with BV and prolonged TTD. Findings further support pembro as the preferred treatment option for pts with R/R cHL who are ineligible for or fail ASCT. The research was funded by: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA Keywords: Hodgkin lymphoma, Immunotherapy Conflicts of interests pertinent to the abstract P. L. Zinzani Consultant or advisory role: Roche, Janssen, Takeda, Eusapharma, Incyte, Beigene, Kirin Kyowa, Takeda, Merck, Bayer, Novartis Honoraria: Servier, AbbVie, Merck, Eusapharma, Novartis, Incyte; Takeda Beigene, Janssen, Roche, Bayer, Sanofi, Kirin Kiowa Other remuneration: Speaker bureau: Merck, Eusapharma, Takeda, Novartis, Kirin Kiowa, Janssen, Roche, Incyte M. Raut Employment or leadership position: Merck & Co., Inc. T. Saretsky Employment or leadership position: Merck & Co., Inc. Stock ownership: Merck & Co., Inc. R. Ramchandren Consultant or advisory role: Seattle Genetics Research funding: Merck, Pharmacyclics, Beigene, BMS A. Santoro Consultant or advisory role: Bristol Myers Squibb, Servier, Gilead, Pfizer, Eisai, Bayer, Merck Sharp & Dohme, Arqule, Sanofi Other remuneration: Speaker bureau: Takeda, Bristol Myers Squibb, Roche, AbbVie, Amgen, Celgene, Servier, Gilead, AstraZeneca, Pfizer, Arqule, Lilly, Sandoz, Eisai, Novartis, Bayer, Merck Sharp & Dohme E. Paszkiewicz-Kozik Educational grants: Roche, Celgene, Takeda, AbbVie R. Gasiorowski Honoraria: MSD, AbbVie, Novartis, Astellas, Takeda N. A. Johnson Consultant or advisory role: Merck, BMS, Roche, Lundbeck, AbbVie, Johnson and Johnson, Seattle Genetics Honoraria: Merck, BMS, Roche, Lundbeck V. Buccheri Consultant or advisory role: AstraZeneca Research funding: AstraZeneca, MSD, Takeda Other remuneration: Speaker bureau: AstraZeneca G. F. Perini Consultant or advisory role: Janssen, AbbVie, Takeda, MSD, AstraZeneca Other remuneration: Speaker bureau: Janssen, AbbVie, Takeda, MSD, AstraZeneca M. Dickinson Consultant or advisory role: Roche, MSD, Novartis, Gilead, Janssen Honoraria: MSD, Roche, Amgen, Janssen, BMS, Novartis, Gilead Research funding: MSD, Novartis, Roche, Takeda, Celgene Other remuneration: Speaker bureau: Novartis A. McDonald Educational grants: Roche, Celgene, Takeda, AbbVie M. Ozcan Honoraria: Takeda, Amgen Research funding: Janssen, Celgene, Takeda, Archigen, Roche, Bayer, MSD, AbbVie, Novartis Educational grants: BMS, Jazz, Roche, Sanofi, Abdi İbrahim, Janssen, Takeda, AbbVie, Amgen N. Sekiguchi Research funding: Ono, A2 Healthcare, Astellas, Janssen, Merck Sharp & Dohme, Otsuka, Pfizer, PPD-SNBL, Sumitomo Dainippon Pharma, Daiichi Sankyo Company, Bristol Myers Squibb H. Giezek Employment or leadership position: Merck & Co., Inc. A. Nahar Employment or leadership position: Merck & Co., Inc. J. Kuruvilla Consultant or advisory role: AbbVie, BMS, Gilead, Karyopharm, Merck, Roche, Seattle Genetics Honoraria: Amgen, Antengene, Astra Zeneca, BMS, Gilead, Incyte, Janssen, Karyopharm, Merck, Novartis, Pfizer, Roche, Seattle Genetics, TG Therapeutics Research funding: Canadian Cancer Society, Leukemia and Lymphoma Society Canada, Princess Margaret Cancer Foundation, Janssen, Roche, AstraZeneca Other remuneration: Data Safety Monitoring Board: Karyopharm