TY - JOUR
T1 - Health-related quality of life with nivolumab plus relatlimab versus nivolumab monotherapy in patients with previously untreated unresectable or metastatic melanoma
T2 - RELATIVITY-047 trial
AU - Schadendorf, Dirk
AU - Tawbi, Hussein
AU - Lipson, Evan J.
AU - Stephen Hodi, F.
AU - Rutkowski, Piotr
AU - Gogas, Helen
AU - Lao, Christopher D.
AU - Grob, Jean Jacques
AU - Moshyk, Andriy
AU - Lord-Bessen, Jennifer
AU - Hamilton, Melissa
AU - Guo, Shien
AU - Shi, Ling
AU - Keidel, Sarah
AU - Long, Georgina V.
N1 - Funding Information:
The authors thank the patients and investigators who participated in the RELATIVITY-047 trial. They acknowledge Ono Pharmaceutical Company, Ltd. (Osaka, Japan) for contributions to nivolumab development. Medical writing and editorial support for the development of this manuscript, under the direction of the authors, were provided by Mark Palangio and Michele Salernitano of Ashfield MedComms, an Inizio company, and funded by Bristol Myers Squibb. Bristol Myers Squibb (Princeton, NJ, USA). Conception and design: Dirk Schadendorf, Hussein Tawbi, Evan J. Lipson, F. Stephen Hodi, Andriy Moshyk, Jennifer Lord-Bessen, Melissa Hamilton, Sarah Keidel, Georgina V. Long. Data acquisition: Dirk Schadendorf, Hussein Tawbi, Evan J. Lipson, F. Stephen Hodi, Piotr Rutkowski, Helen Gogas, Christopher D. Lao, Jean-Jacques Grob, Sarah Keidel, Georgina V. Long. Data analysis: Shien Guo, Ling Shi. Data interpretation: Dirk Schadendorf, Hussein Tawbi, Evan J. Lipson, F. Stephen Hodi, Piotr Rutkowski, Helen Gogas, Christopher D. Lao, Jean-Jacques Grob, Andriy Moshyk, Jennifer Lord-Bessen, Melissa Hamilton, Sarah Keidel, Georgina V. Long. Manuscript writing: All authors. Final approval of manuscript: all authors. Accountable for all aspects of the work: all authors.
Publisher Copyright:
© 2023 The Author(s)
PY - 2023/7
Y1 - 2023/7
N2 - Background: In the phase II/III RELATIVITY-047 trial, a novel fixed-dose combination (FDC) of nivolumab plus relatlimab (NIVO + RELA; a programmed death-1 and a lymphocyte-activation gene 3 inhibitor, respectively) significantly improved progression-free survival (PFS) versus NIVO in patients with previously untreated unresectable or metastatic melanoma (median follow-up, 13.2 months) with stable health-related quality of life (HRQoL), although grade three or four treatment-related adverse events (TRAEs) were more frequent with the combination. Updated HRQoL results (median follow-up, 19.3 months) are presented. Methods: Patients were randomised to receive intravenous NIVO + RELA (480 mg and 160 mg, respectively) or NIVO (480 mg) every 4 weeks. HRQoL was assessed using the Functional Assessment of Cancer Treatment-Melanoma (FACT-M) and EQ-5D-3L questionnaires at baseline, before dosing at each treatment cycle, and at follow-up (posttreatment) visits. Results: Consistent with the initial analysis, HRQoL remained stable with NIVO + RELA on treatment and was similar to that with NIVO. Mean changes from baseline did not exceed clinically meaningful thresholds. HRQoL results were consistent across instruments and scales/subscales. Despite an increased rate of grade three or four TRAEs with NIVO + RELA versus NIVO, the proportion of patients reporting that they were bothered 'quite a bit' or 'very much' by TRAEs was low and comparable between treatments. Conclusion: Results from the RELATIVITY-047 trial show that the PFS benefit with NIVO + RELA FDC over NIVO was obtained with stable patient-reported HRQoL, supporting NIVO + RELA as a first-line treatment option for patients with advanced melanoma.
AB - Background: In the phase II/III RELATIVITY-047 trial, a novel fixed-dose combination (FDC) of nivolumab plus relatlimab (NIVO + RELA; a programmed death-1 and a lymphocyte-activation gene 3 inhibitor, respectively) significantly improved progression-free survival (PFS) versus NIVO in patients with previously untreated unresectable or metastatic melanoma (median follow-up, 13.2 months) with stable health-related quality of life (HRQoL), although grade three or four treatment-related adverse events (TRAEs) were more frequent with the combination. Updated HRQoL results (median follow-up, 19.3 months) are presented. Methods: Patients were randomised to receive intravenous NIVO + RELA (480 mg and 160 mg, respectively) or NIVO (480 mg) every 4 weeks. HRQoL was assessed using the Functional Assessment of Cancer Treatment-Melanoma (FACT-M) and EQ-5D-3L questionnaires at baseline, before dosing at each treatment cycle, and at follow-up (posttreatment) visits. Results: Consistent with the initial analysis, HRQoL remained stable with NIVO + RELA on treatment and was similar to that with NIVO. Mean changes from baseline did not exceed clinically meaningful thresholds. HRQoL results were consistent across instruments and scales/subscales. Despite an increased rate of grade three or four TRAEs with NIVO + RELA versus NIVO, the proportion of patients reporting that they were bothered 'quite a bit' or 'very much' by TRAEs was low and comparable between treatments. Conclusion: Results from the RELATIVITY-047 trial show that the PFS benefit with NIVO + RELA FDC over NIVO was obtained with stable patient-reported HRQoL, supporting NIVO + RELA as a first-line treatment option for patients with advanced melanoma.
KW - Health-related quality of life
KW - Melanoma
KW - Nivolumab
KW - Patient-reported outcomes
KW - Relatlimab
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UR - http://www.scopus.com/inward/citedby.url?scp=85158817828&partnerID=8YFLogxK
U2 - 10.1016/j.ejca.2023.03.014
DO - 10.1016/j.ejca.2023.03.014
M3 - Article
C2 - 37167764
AN - SCOPUS:85158817828
SN - 0959-8049
VL - 187
SP - 164
EP - 173
JO - European Journal of Cancer
JF - European Journal of Cancer
ER -