1962O - Health-related quality of life from the CheckMate 901 trial of nivolumab as first-line therapy for unresectable or metastatic urothelial carcinoma

Background

In the phase 3 CheckMate 901 trial (NCT03036098), upfront nivolumab (NIVO) plus gemcitabine-cisplatin (GC) followed by NIVO significantly prolonged overall survival and progression-free survival vs GC alone in cisplatin-eligible patients (pts) with untreated unresectable or metastatic UC. Here, we evaluate the effect of NIVO+GC on HRQoL in CheckMate 901.

Methods

Pts completed the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and EQ-5D-5L at wks 1, 4, 10, 12, and 16 (both arms) and at wks 20, 24, and every 12 wks thereafter (NIVO+GC arm only). In a noninferiority analysis, a mixed effect model for repeated measures used data for pts with an evaluable assessment at baseline and ≥ 1 post-baseline assessment to estimate differences in overall least square (LS) mean changes from baseline to wk 16. Descriptive change from baseline based on Eastern Cooperative Oncology Group performance status (ECOG PS) (0 vs 1), presence of visceral metastasis, and whether complete or partial response was achieved were also evaluated.

Results

Overall, 276 pts in the NIVO+GC arm and 248 in the GC alone arm were included in the analyses. Baseline scores for the prespecified scales of interest were generally comparable with population norms. Completion rates were above 75% through wk 10, and generally above 60% through wk 24. Overall LS mean changes up to wk 16 showed noninferiority of NIVO+GC vs GC alone on all key scale scores (Table). Change from baseline was similar across both arms in subgroups based on baseline ECOG PS, presence of visceral metastasis, or achievement of response for all evaluated patient-reported outcome domains.

Conclusions

Addition of NIVO to GC had minimal impact on HRQoL vs GC alone. This further supports NIVO+GC as a first-line therapy for cisplatin-eligible pts with unresectable or metastaticUC. Table. Overall LS mean changes to wk 16 (prespecified scales of interest). Table: 1962O

^aLower bound of minimum important difference (Cocks K, et al. J Clin Oncol 2011;29:89-96). CI, confidence interval.

Clinical trial identification

NCT03036098.

Editorial acknowledgement

Medical writing support was provided by Stephen Gilliver, PhD, of Evidera, and editorial assistance was provided by Erika Young, PharmD, of Parexel, funded by Bristol Myers Squibb.

Legal entity responsible for the study

Bristol Myers Squibb.

Funding

Bristol Myers Squibb.

Disclosure

J. Bedke: Financial Interests, Personal, Advisory Board: AstraZeneca, Astellas, BMS, Eisai, Ipsen, MSD, MSD Oncology, Pfizer, Roche, Janssen; Financial Interests, Institutional, Advisory Board: BMS, Pfizer; Financial Interests, Institutional, Invited Speaker: AstraZeneca, Astellas, BMS, Eisai, MSD, Ipsen, Novartis, Nektar, Pfizer, Roche, Seagen; Other, Member: European Association of Urology. L. Shi: Financial Interests, Institutional, Full or part-time Employment, Receiving salary from this company: Evidera, Inc; Financial Interests, Institutional, Stocks/Shares, Receiving stocks as an employee: Evidera, Inc. S.I. Blum: Financial Interests, Personal, Full or part-time Employment, Full-time Employee of Bristol Myers Squibb: Bristol Myers Squibb; Financial Interests, Personal, Stocks/Shares, Stock shareholder of Bristol Myers Squibb: Bristol Myers Squibb; Financial Interests, Personal, Stocks/Shares, Stock shareholder of: GSK. M. Patel: Financial Interests, Personal, Full or part-time Employment: Bristol Myers Squibb; Financial Interests, Personal, Stocks/Shares: Bristol Myers Squibb. T.B. Powles: Financial Interests, Personal, Advisory Board: AstraZeneca, Bristol Myers Squibb, Exelixis, Incyte, Ipsen, Merck, Novartis, Pfizer, Seattle Genetics, Merck Serono, Astellas, Johnson & Johnson, Eisai, Roche, MSD; Financial Interests, Personal, Other, Travel/Accommodation/Expenses: Roche, Pfizer, MSD, AstraZeneca, Ipsen; Financial Interests, Personal, Other, Sponsorship for Uromigos Podcast: Mashup Ltd; Financial Interests, Institutional, Other, honoraria: Gilead; Financial Interests, Institutional, Research Grant: AstraZeneca, Roche, Bristol Myers Squibb, Exelixis, Ipsen, Merck, MSD, Seattle Genetics, Novartis, Pfizer, Merck Serono, Astellas, Johnson & Johnson, Eisai; Financial Interests, Institutional, Other, Honoraria: Gilead. All other authors have declared no conflicts of interest.