Abstract 682P
Background
Nivolumab plus ipilimumab (NIVO+IPI) and pembrolizumab plus axitinib (PEM+AXI) received US FDA approval in 2018 and 2019, respectively, as first-line (1L) therapy for patients (pts) with aRCC, with superior efficacy versus sunitinib. This real-world study assessed characteristics, clinical outcomes, and safety profiles of aRCC pts receiving each 1L regimen at nonacademic US practices.
Methods
Oncologists reviewed medical charts of aRCC pts initiating 1L NIVO+IPI after May 2018, 1L PEM+AXI after May 2019, or 1L TKI monotherapy (sunitinib, pazopanib, or cabozantinib). Pt demographics, clinical characteristics, and clinical outcomes were abstracted from medical records. Disease response, landmark progression-free survival (PFS), overall survival (OS), and adverse event (AE) rates were calculated for all treated pts and for pts with IMDC/MSKCC intermediate/poor (I/P) risk and compared between cohorts.
Results
The study included 133 pts treated with NIVO+IPI, 105 treated with PEM+AXI, and 130 treated with TKI monotherapy, of whom 94%, 83%, and 59% had I/P-risk disease, respectively. Median follow-up from 1L was 7.2, 6.7, and 5.7 months for each cohort regardless of risk, respectively. Median time to best response was 3.4, 3.6, and 3.5 months; complete response rates were 17.9%, 5.6%, and 6.9% in all pts, respectively (overall response in the table). Any-grade AEs occurred in 29% of pts with NIVO+IPI, 34% with PEM+AXI, and 41% with TKI (P = 0.02). Landmark PFS and OS rates at 6 and 9 months are shown in the table, as are study results in I/P-risk pts. Table: 682P
| All pts | I/P-risk pts | |||||
| NIVO+IPI | PEM+AXI | TKI | NIVO+IPI | PEM+AXI | TKI | |
| ORR, %a,b | 80 | 80 | 67 | 83 | 77 | 58 |
| Median time to best response, months | 3.4 | 3.6 | 3.5 | 3.5 | 3.5 | 3.5 |
| PFS, % | ||||||
| 6 months | 86 | 88 | 80 | 89 | 87 | 75 |
| 9 months | 79 | 72 | 69 | 81 | 69 | 64 |
| OS, % | ||||||
| 6 monthsa | 94 | 95 | 85 | 95 | 94 | 80 |
| 9 monthsa,b | 86 | 89 | 79 | 87 | 86 | 74 |
a P < 0.05 for all pts; b P < 0.05 for I/P risk.Statistical comparison by chi-square, ANOVA, and log-rank test.
Conclusions
Time to best response was similar for all regimens and risk groups; the unadjusted complete response rate was significantly higher for pts treated with NIVO+IPI compared with PEM+AXI or TKI monotherapy. The lowest rate of AEs was observed with NIVO+IPI. These real-world results support the efficacy and safety profile of NIVO+IPI demonstrated in the CheckMate 214 pivotal trial.
Clinical trial identification
Editorial acknowledgement
Editorial assistance was provided by Parexel, funded by Bristol Myers Squibb.
Legal entity responsible for the study
Bristol Myers Squibb.
Funding
Bristol Myers Squibb.
Disclosure
D. Geynisman: Financial Interests, Personal, Advisory Board: Astellas; Financial Interests, Personal, Advisory Board: Exelixis; Financial Interests, Personal, Advisory Board: Genentech; Financial Interests, Personal, Advisory Board: Merck; Financial Interests, Personal, Advisory Board: Pfizer; Financial Interests, Institutional, Principal Investigator, Local PI: Genentech; Financial Interests, Institutional, Principal Investigator, Local PI: Harpoon; Financial Interests, Institutional, Principal Investigator, Local PI: Merck; Financial Interests, Institutional, Principal Investigator, Local PI: Seattle Genetics. J.K. Kish: Financial Interests, Personal, Full or part-time Employment, I am an employee of Cardinal Health which receives research funding from biopharmaceutical companies to perform research: Cardinal Health; Financial Interests, Personal, Stocks/Shares, I am an employee of Cardinal Health which receives funding toconduct research for biopharmaceutical companies: Cardinal Health; Financial Interests, Institutional, Principal Investigator, Local PI, Cardinal Health receives funding from BristolMyers Squibb to conduct research: BMS. A. Falkenstein: Financial Interests, Personal, Full or part-time Employment: Cardinal Health. V. Del Tejo: Financial Interests, Personal, Full or part-time Employment: BMS. B. Stwalley: Financial Interests, Personal, Full or part-time Employment: BMS; Financial Interests, Personal, Stocks/Shares: BMS. S. Huo: Financial Interests, Personal, Full or part-time Employment: BMS; Financial Interests, Personal, Stocks/Shares: BMS. A. Balanean: Financial Interests, Personal, Full or part-time Employment: Cardinal Health; Other, Personal, Other, Full-time PhD student and part-time university employee in Biology department, Aug 2019-Jan 2021: Georgia State University; Other, Personal, Other, Full-time MPH student and part-time university employee (August 2017-August 2019): Loyola University Chicago. B.A. Feinberg: Financial Interests, Personal, Full or part-time Employment: Cardinal Health.