Abstract 1460P
Background
Nivolumab (NIVO) showed improved HRQoL versus everolimus in the phase 3, randomized CheckMate 025 trial of patients (pts) with previously treated mRCC. However, HRQoL data from RW settings are limited. Here, we report HRQoL outcomes for pts receiving NIVO for previously treated mRCC in 2 European RW studies.
Methods
As a part of the IO-Synthesise RCC initiative, data for adult pts with mRCC who received second- (2L) or third-line (3L) NIVO monotherapy were pooled from the French WITNESS (NCT03455452) and German NORA (NCT02940639) prospective, noninterventional studies. HRQoL measures included the Functional Assessment of Cancer Therapy Kidney Symptom Index-19 (FKSI-19) and EQ-5D-3L utility index (UI) and visual analog scale (VAS). All pts with a baseline HRQoL assessment were included.
Results
Data from 306 pts (France, N = 105; Germany, N = 201) were pooled. Median age was 70 years, 74.5% were male. In pts with available data, 75.5% had a Karnofsky performance score (KPS) > 70%. NIVO was given as 2L in 83.3%. Baseline characteristics were mostly consistent between French and German pts; a higher proportion of French pts with available data had a KPS ≤ 70% (37.6% vs 16.9%) and a lower proportion had prior nephrectomy (65.7% vs 86.4%). Completion rates for all individual measures/subscales were > 70% at week 6 and ∼47% at month 18. Results are summarized in the table; no significant HRQoL decrements were observed and a numerical trend for improved FKSI-19 total and disease-related symptoms (DRS) subscale scores was seen at most timepoints. Table: 1460P
Mean change from baseline (95% CI)
| Week 6 | Month 3 | Month 6 | Month 9 | Month 12 | Month 18 | |
| FSKI-19 | ||||||
| n = 221 | n = 192 | n = 128 | n = 99 | n = 84 | n = 47 | |
| Total | 0.53 (–0.76, 1.82) | –0.25 (–1.83, 1.33) | 0.68 (–1.40, 2.77) | 1.62 (–0.42, 3.65) | 2.71a (0.38, 5.04) | 1.28 (–1.39, 3.95) |
| DRS | 0.43 (–0.24, 1.11) | –0.26 (–1.09, 0.56) | –0.01 (–1.10, 1.08) | 0.38 (–0.65, 1.40) | 1.58a (0.40, 2.76) | 1.05 (–0.46, 2.56) |
| EQ-5D-3L | ||||||
| UI | n = 208 0.0 (–0.03, 0.04) | n = 184 –0.02 (–0.06, 0.02) | n = 125 –0.05 (–0.10, 0.01) | n = 94 –0.04 (–0.10, 0.01) | n = 80 –0.02 (–0.09,0.06) | n = 44 –0.02 (–0.11, 0.06) |
| VAS | n = 192 –0.01 (–2.91, 2.89) | n = 170 1.25 (–1.82, 4.32) | n = 118 1.44 (–2.85, 5.73) | n = 91 1.56 (–3.17, 6.28) | n = 75 –3.24 (–9.31, 2.82) | n = 43 –6.09 (–13.09, 0.91) |
a P < 0.05 vs baseline.
Conclusions
Despite the challenge of suboptimal HRQoL completion rates in RW settings, pooled HRQoL data from these pts with mRCC receiving 2L or 3L NIVO in France and Germany appear to complement results from CheckMate 025 and suggest pts with previously treated mRCC maintain HRQoL after receiving NIVO.
Clinical trial identification
Editorial acknowledgement
Professional medical writing assistance was provided by Richard Daniel, PhD, of Parexel, funded by Bristol Myers Squibb.
Legal entity responsible for the study
Bristol Myers Squibb.
Funding
Bristol Myers Squibb.
Disclosure
G. Mouillet: Financial Interests, Personal, Advisory Board: Pfizer, Merck; Financial Interests, Personal, Invited Speaker: Bristol Myers Squibb. J. Bedke: Financial Interests, Personal, Advisory Board: Astellas, AstraZeneca, Eisai, Eusa Pharma; Financial Interests, Personal, Advisory Board, and Speakers Bureau: Bristol Myers Squibb, Ipsen, Janssen, Merck Serono, MSD, Pfizer, Roche; Financial Interests, Institutional, Advisory Board: Bristol Myers Squibb, Pfizer; Financial Interests, Institutional, Other, Coordinating PI: Astellas, Bristol Myers Squibb, Ipsen, MSD, Pfizer, Roche, Seagen; Financial Interests, Institutional, Other, Local PI: AstraZeneca, Eisai, Nektar, Novartis; Financial Interests, Institutional, Other, Steering Committe Member: Bristol Myers Squibb, MSD, Pfizer. L. Albiges: Other, Institutional, Other, consultin: Astellas, Bristol Myers Squibb, Eisai, Ipsen; Other, Institutional, Other, onsultin: AstraZeneca; Financial Interests, Institutional, Other, consultin: Janssen, Merck, Novartis, Pfizer; Financial Interests, Institutional, Invited Speaker, consultin: MSD; Non-Financial Interests, Personal, Principal Investigator: AstraZeneca, Aveo, Bristol Myers Squibb, Ipsen, MSD, Pfizer; Non-Financial Interests, Personal, Other, clinical trial steering committee: Exelixis; Other, Personal, Other, clinical trial steering committee: Roche; Non-Financial Interests, Personal, Member, ASCO member: ASCO member; Other, Personal, Other, Member of the renal cell carcinoma guidelines panel: EAU; Other, Personal, Other, Member of the Kidney Cancer Research Summit scientific committee of 2021: Kidney Can; Other, Personal, Other, medical steering committee: Kidney Cancer Association; Other, Personal, Other, scientific committee: Bristol Myers Squibb. P. Barthelemy: Financial Interests, Personal, Funding, medical writing funding: Bristol Myers Squibb; Financial Interests, Institutional, Research Grant: Bristol Myers Squibb, Ipsen, MSD, Pfizer, AstraZeneca, Janssen; Financial Interests, Personal, Other, Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events: Bristol Myers Squibb, Ipsen, MSD, Merck, Pfizer, Janssen-Cilag, Astellas, Bayer, Sanofi, Seagen, Novartis; Financial Interests, Personal, Other, Support for attending meetings and/or travel: Bristol Myers Squibb, Ipsen, MSD, Merck, Pfizer, Janssen-Cilag, Astellas, Sanofi, Seagen, Novartis. B. Escudier: Financial Interests, Personal, Advisory Board: Pfizer, Bristol Myers Squibb, Ipsen, Aveo, Eisai. V. Gruenwald: Financial Interests, Personal, Advisory Board: Apogepha, Bristol Myers Squibb, Debiopharm, Eisai, Merck Serono, MSD, Nanobiotix, Oncorena, PCI Biotech, Pfizer, Roche, EUSA Pharm; Financial Interests, Personal, Invited Speaker: Astellas, AstraZeneca, Bristol Myers Squibb, Eisai, Ipsen, Janssen-Cilag, Merck Serono, MSD, Pfizer, Roche, Novartis; Financial Interests, Personal, Stocks/Shares: AstraZeneca, Bristol Myers Squibb, MSD, Seattle Genetics, Seattle Genetics; Financial Interests, Institutional, Research Grant: Bristol Myers Squibb, MSD; Non-Financial Interests, Personal, Other, Steering Committee Member: Bristol Myers Squibb; Financial Interests, Personal and Institutional, Other, Steering Committee Member: Eisai, Novartis; Financial Interests, Personal and Institutional, Research Grant: Ipsen; Non-Financial Interests, Personal, Research Grant: Pfizer; Non-Financial Interests, Personal, Other, trial chair: PharmaMar. P. Ivanyi: Financial Interests, Personal, Invited Speaker: Apogepha, AstraZeneca, Bayer, Bristol Myers Squibb, Boehringer Ingelheim, ClinSol, Dicephera, DKG-Onkowen, Eisai, GSK, H5Oncology, Ipsen, Merck, MSD, Onkowissen, Pharma Mare, Roche; Financial Interests, Personal, Advisory Board: Bayer, Bristol Myers Squibb, Dicephera, Eisai, Ipsen, Merck, MSD, Onkowissen, Pfizer; Financial Interests, Personal, Expert Testimony: ClinSol, EMD Serono, Merck, Metaplan, Pfizer; Financial Interests, Personal, Writing Engagements: Pfizer; Financial Interests, Personal, Stocks/Shares: BB-Biotech; Non-Financial Interests, Institutional, Other, local PI: AstraZeneca, Ipsen; Non-Financial Interests, Institutional, Other, Coordinating PI: Bristol Myers Squibb, GSK, MSD; Other, Personal, Other, spokesman: Interdisciplinary Kidney Cancer Group of German Cancer Society. H. Mueller-Huesmann: Financial Interests, Personal, Other, honoraria: Roche, Bristol Myers Squibb, Boehringer-Ingelheim, AstraZeneca; Financial Interests, Personal, Other, consulting advisory role: Roche, Bristol Myers Squibb, Boehringer-Ingelheim, AstraZeneca, Servier; Non-Financial Interests, Institutional, Research Grant: Roche, Bristol Myers Squibb; Financial Interests, Institutional, Research Grant: Boehringer-Ingelheim, AstraZeneca; Financial Interests, Personal, Other, travel/accommodation expenses: Celgene, Janssen; Financial Interests, Personal, Advisory Board, consulting or advisory role/honoraria: Seagen. Y. Vano: Financial Interests, Personal, Advisory Board: Bristol Myers Squibb, Ipsen, Merck, MDS, Novartis, Pfizer; Financial Interests, Institutional, Other, Funding support for the BIONIKK study: Bristol Myers Squibb; Financial Interests, Personal, Other, member of the scientific committee of the WITNESS study: Bristol Myers Squibb; Financial Interests, Institutional, Other, Funding support for the CABIR study: Ipsen. E. von der Heyde: Financial Interests, Personal, Other, honoraria: Bristol Myers Squibb, AstraZeneca, Boehringer Ingelheim, Ipsen, Pierre-Fabre, Novartis; Financial Interests, Personal, Other, funding for scientific research: Aufwendungen fur Nicht Interventionelle Studien (NIS), Novartis, Bristol Myers Squibb, Boehringer Ingelheim, Ipsen. F. Ejzykowicz: Other, Personal, Full or part-time Employment, BMS Employee: Bristol Myers Squibb; Financial Interests, Personal, Stocks/Shares, owns stock in BMS: Bristol Myers Squibb. F. Brellier: Financial Interests, Personal and Institutional, Stocks/Shares, Own stock in BMS: Bristol Myers Squibb; Financial Interests, Personal and Institutional, Full or part-time Employment, Full time employee of BMS: Bristol Myers Squibb. M. Herber: Financial Interests, Personal, Full or part-time Employment, employee of BMS: Bristol Myers Squibb; Financial Interests, Personal, Stocks/Shares, owns BMS stock: Bristol Myers Squibb. C. Quentric: Financial Interests, Personal, Full or part-time Employment, employee of BMS: Bristol Myers Squibb; Financial Interests, Personal, Stocks/Shares, holds BMS stock: Bristol Myers Squibb. B.M. Bennett: Financial Interests, Personal, Full or part-time Employment, I am a full time employee of BMS: Bristol Myers Squibb; Financial Interests, Personal, Stocks/Shares, I own shares in BMS: Bristol Myers Squibb. S. Nere: Financial Interests, Personal, Full or part-time Employment: Bristol Myers Squibb; Financial Interests, Personal, Stocks/Shares: Bristol Myers Squibb. A. Autengruber: Financial Interests, Personal, Full or part-time Employment, Medical Manager: Bristol Myers Squibb. A. Thiery-Vuillemin: Financial Interests, Personal, Advisory Board: Astellas, MSD, Novartis, Roche/Genentech, Sanofi; Financial Interests, Personal, Advisory Board, personal and public speaking: AstraZeneca, Bristol Myers Squibb, Ipsen, Janssen, Pfizer; Financial Interests, Institutional, Other, local PI: Astellas Pharma, AstraZeneca, Bristol Myers Squibb, Exelixis, Incyte, Ipsen, JNJ, MSD, Novartis, Pfizer, Roche, Sanofi, UNICANCER/GETUG; Non-Financial Interests, Personal, Invited Speaker, Steering Committee Member: AstraZeneca; Financial Interests, Institutional, Funding: Bayer, Ipsen, Pfizer; Non-Financial Interests, Institutional, Other, Steering Committee Member: Bristol Myers Squibb; Non-Financial Interests, Personal, Other, Steering Committee Member: Novartis; Non-Financial Interests, Personal, Member: ASCO Member, GETUG member; Other, Personal, Other, Travel Accommodations: Astellas Pharma, AstraZeneca, BMS, Ipsen, JNJ, MSD. M. Grimm: Financial Interests, Personal, Advisory Board: Astellas, AstraZeneca, Bayer, Bristol Myers Squibb, Eisai, EUSA Pharma, Ipsen Pharma, Merck Serono, MSD, Pfizer, Roche, Takeda; Financial Interests, Personal, Invited Speaker: Astellas, AstraZeneca, Bristol Myers Squibb, Ipsen Pharma, Merck Serono, MSD, Pfizer; Financial Interests, Personal, Member of the Board of Directors: Deutsche Gesellschaft Fur Urologie; Financial Interests, Personal and Institutional, Other, coordinating PI: Bristol Myers Squibb; Financial Interests, Institutional, Other, local PI: Intuitive Surgical, Novartis.