Abstract 1135P
Background
Nivolumab + ipilimumab (N + I) alone or with limited chemo (LC; up to 6 weeks [wks]) provide new 1L treatment (tx) options for aNSCLC; but the relative contributions of the different agents to the AE profile over time have not been assessed. Here, we quantified the AE rates and associated costs for N + I, N + I + LC, and N + chemo (C; 12+ wks) over time during tx for 1L aNSCLC.
Methods
Exposure-adjusted event rates (EAERs) were calculated as the number of occurrences of all-cause grade 3–5 AEs per patient-year (PY), using individual patient data from the CheckMate 227 Parts 1 and 2 and CheckMate 9LA trials (minimum follow-up: 48, 38, and 23 months, respectively). EAERs were estimated for the overall trial period and at 5 pre-specified time periods (wks 0–6, 7–12, 13–24, 25–48, and 49+) to assess the impact of tx on AE burden. AE costs per patient were estimated as the rates of grade 3–5 AEs (with any-grade incidence ≥15%) multiplied by the corresponding unit hospitalization costs for AE management obtained from the 2019 US Healthcare Cost and Utilization Project National Inpatient Sample database.
Results
EAERs of all-cause grade 3–5 AEs per PY were lower with N + I (4.8) vs N + I + LC (7.0) and N + C (6.1) at wks 0–6 and lower with N + I (4.0) and N + I + LC (3.1) vs N + C (5.2) at wks 7–12, when chemo was administered; EAERs for the total exposure time period were similar in the N + I (2.6), N + I + LC (2.5), and N + C (2.5) tx groups (Table). EAERs continued to decline in subsequent wks in all 3 tx groups. Overall AE costs were lower with N + I ($6560) and N + I + LC ($7492) vs N + C ($11,731); similar trends were seen per time period. Table: 1135P
| Time period, wks | EAERa | AE costb, $ | ||||
| N 3 mg/kg Q2W + I 1 mg/kg Q6W n = 576 | N 360 mg Q3W + I 1 mg/kg Q6W + LC Q3W, up to 2 cycles n = 358 | N 360 mg Q3W + C Q3W, 4+ cycles n = 547 | N 3 mg/kg Q2W + I 1 mg/kg Q6W n = 576 | N 360 mg Q3W + I 1 mg/kg Q6W + LC Q3W, up to 2 cycles n = 358 | N 360 mg Q3W + C Q3W, 4 + cycles n = 547 | |
| 0–6 | 4.8 | 7.0 | 6.1 | 2033 | 3155 | 3715 |
| 7–12 | 4.0 | 3.1 | 5.2 | 1650 | 1157 | 3328 |
| 13–24 | 2.5 | 2.2 | 2.7 | 944 | 1080 | 2374 |
| 25–48 | 1.7 | 1.7 | 1.2 | 1057 | 1423 | 1180 |
| 49+ | 1.5 | 1.1 | 1.0 | 875 | 676 | 1134 |
| Overall | 2.6 | 2.5 | 2.5 | 6560 | 7492 | 11,731 |
aPer PY (defined as the total exposure time [time between date of first dose and the earliest among last dose date + 30 days, cutoff date, and date of death] for each patient at risk of AE); bPer patient. 1 cycle = 3 wks; Q2W, every 2 wks; Q3W, every 3 wks; Q6W, every 6 wks.
Conclusions
Higher incidence of AEs and AE costs associated with N + I + LC and N + C vs N + I correlated with the time when chemo was administered during tx; toxicities and costs declined over time after chemo was completed. Results imply an overall lower AE cost burden with 1L N + I compared with IO + chemo-based tx regimens for aNSCLC.
Clinical trial identification
NCT02477826 (CheckMate 227); NCT03215706 (CheckMate 9LA).
Editorial acknowledgement
Writing and editorial assistance was provided by Vidya Rajagopalan, PhD, of Envision Pharma Group funded by Bristol Myers Squibb; Analysis Group, Inc. provided the first draft as part of their role as authors.
Legal entity responsible for the study
Bristol Myers Squibb, Princeton, NJ, USA.
Funding
Bristol Myers Squibb, Princeton, NJ, USA.
Disclosure
L. Schwartzberg: Financial Interests, Personal, Advisory Board: AstraZeneca, Sanofi, Bristol Myers Squibb, Napo, Spectrum, Seagen, Lilly, Pfizer, Coherus, AbbVie, Genentech, Novartis; Financial Interests, Personal, Speaker’s Bureau: Seagen, Pfizer, Coherus, Merck; Financial Interests, Personal, Principal Investigator: Genentech; Financial Interests, Personal, Stocks/Shares: OneOncology; Financial Interests, Personal, Advisory Role: OneOncology. A. Wu: Financial Interests, Personal and Institutional, Full or part-time Employment: Analysis Group, Inc.; Financial Interests, Institutional, Other, Institution received consulting fees for this work: Bristol Myers Squibb. J. Hartman: Financial Interests, Personal, Full or part-time Employment: Bristol Myers Squibb; Financial Interests, Personal, Stocks/Shares: Bristol Myers Squibb. T. Wang: Financial Interests, Personal and Institutional, Full or part-time Employment: Analysis Group, Inc.; Financial Interests, Institutional, Other, Institution received consulting fees for this work: Bristol Myers Squibb. X. Yin: Financial Interests, Personal, Full or part-time Employment: Bristol Myers Squibb. J. Chen: Financial Interests, Personal and Institutional, Full or part-time Employment: Analysis Group, Inc.; Financial Interests, Institutional, Other, Institution received consulting fees for this work: Bristol Myers Squibb. K.A. Betts: Financial Interests, Personal, Full or part-time Employment: Analysis Group, Inc.; Financial Interests, Institutional, Other, Institution received consulting fees for this work: Bristol Myers Squibb. S.J. Lubinga: Financial Interests, Personal, Full or part-time Employment: Bristol Myers Squibb; Financial Interests, Personal, Stocks/Shares: Bristol Myers Squibb.