Abstract 717P
Background
Survival benefits in 1L treatment of aRCC for patients with I/P IMDC risk groups have been demonstrated with nivolumab + ipilimumab (N+I) and pembrolizumab + axitinib (P+A) compared with sunitinib (S). CE evaluations are typically based on mean survival, requiring survival estimates beyond clinical trial data.
Methods
Observed survival from randomized controlled trials was extrapolated using standard parametric and spline distributions to estimate mean lifetime survival and landmark survival. Multiple parametric distributions were tested in scenario analyses. Survival of patients by treatment was estimated via independent models, as statistical tests showed proportional hazards could not be assumed. Alternative approaches, such as fractional polynomial network meta-analysis, were deemed less robust due to short follow-up with P+A (Jan 2019 cutoff). Survival estimates for cabozantinib (C), which is licensed for I/P risk patients, were explored but deemed clinically implausibly low relative to N+I, P+A, and S. Mean survival estimates were inputs to the CE model, which used a partitioned survival framework to estimate costs (year 2020), life-years (LYs), and quality-adjusted LYs (QALYs) over a horizon of 40 years. The analysis utilized a US healthcare perspective.
Results
Landmark survival estimates were higher for N+I and P+A than S at 5 and 10 years (Table). N+I was associated with the highest LYs and discounted QALYs of all treatments. Compared with S, N+I was associated with >2 times the LY gain achieved with P+A. Relative to S, total discounted incremental costs were lower for N+I than P+A, including disease management and subsequent therapy costs. Table: 717P
| Treatment arm | 5-year survival, % | 10-year survival, % | LYs | Incremental LYs vs S | QALYsa | Total costa | Incremental costa vs S |
| S | 31 | 17 | 5.7 | – | 3.6 | $394k | – |
| N+I | 42 | 25 | 7.6 | 2.0 | 4.9 | $485k | $91k |
| P+A | 38 | 19 | 6.5 | 0.8 | 4.1 | $727k | $333k |
a3% annual discounting.
Conclusions
N+I offers aRCC patients with I/P risk a potential cost-effective treatment option with higher estimated mean long-term survival versus other 1L treatments in the US.
Clinical trial identification
NCT02231749.
Editorial acknowledgement
This research was sponsored by Bristol-Myers Squibb Company. Professional medical writing from Samantha Rivera, MS, and editorial assistance were provided by Peloton Advantage, LLC, an OPEN Health company, Parsippany, NJ, USA, and were funded by Bristol-Myers Squibb Company.
Legal entity responsible for the study
Bristol-Myers Squibb Company.
Funding
Bristol-Myers Squibb Company and ONO Pharmaceutical Company Ltd.
Disclosure
T.K. Choueiri: Shareholder/Stockholder/Stock options: Pionyr; Shareholder/Stockholder/Stock options: Tempest; Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses, Non-remunerated activity/ies: BMS; Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses, Non-remunerated activity/ies: Exelixis; Speaker Bureau/Expert testimony, Research grant/Funding (institution), Travel/Accommodation/Expenses, Non-remunerated activity/ies: AstraZeneca; Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses, Spouse/Financial dependant: Lilly; Speaker Bureau/Expert testimony, Research grant/Funding (institution), Travel/Accommodation/Expenses, Spouse/Financial dependant: Eisai; Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses, Non-remunerated activity/ies: Novartis; Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses, Non-remunerated activity/ies: GSK; Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses, Non-remunerated activity/ies: Pfizer; Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses, Non-remunerated activity/ies: EMD Serono; Officer/Board of Directors, Sit on NCCN panel: NCCN. B. Stwalley: Shareholder/Stockholder/Stock options, Full/Part-time employment: BMS. S. Huo: Full/Part-time employment: BMS. J.R. May: Full/Part-time employment: BMS. B. Malcolm: Full/Part-time employment: BMS. K. Nickel: Research grant/Funding (institution): BMS. N. Szabo: Research grant/Funding (institution): BMS. S. Klijn: Research grant/Funding (institution): BMS.