KEY TAKEAWAYS
- The phase 3 CheckMate-9LA trial aimed to compare the adverse event (AE) rates and expenditures over time for N + I alone or with LC; for up to 6 wks and N + C; 12+ wks therapy for 1L aNSCLC.
- Individual patient data from CheckMate-227 Parts 1 and 2 and CheckMate-9LA trials were used to determine EAERs and calculate AE expenses per patient.
- The EAERs of all-cause grade 3-5 AEs per patient-year (PY) were lower with N + I than N + I + LC and N + C at weeks 0-6 and more down with N + I and N + I + LC than N + C at weeks 7-12.
- Toxicities and expenses peaked when chemotherapy was administered, especially for N + I + LC and N + C compared to N + I, and gradually decreased once chemotherapy ended.
- The findings suggest that 1L N + I has a lower AE cost burden than IO + chemo-based tx regimens for aNSCLC.
There are now new 1L therapy (tx) options for aNSCLC, including nivolumab + ipilimumab (N + I) alone or with limited chemo (LC; up to 6 weeks [wks]). However, the relative contributions of the individual agents to the AE profile over time have not been examined. For 1L aNSCLC, researchers compared the AE rates and expenditures throughout time for N + I, N + I + LC, and N + chemo (C; 12+ wks) tx. Individual patient data from the CheckMate-227 Parts 1 and 2 and the CheckMate-9LA trials (minimum follow-up: 48, 38, and 23 months, respectively) were used to determine exposure-adjusted event rates (EAERs) as the number of occurrences of all-cause grade 3-5 AEs per patient-year (PY). To evaluate the effect of tx on AE burden, researchers compared EAERs for the entire trial duration and at 5 pre-specified time intervals (weeks 0-6, 7-12, 13-24, 25-48, and 49+). The unit hospitalization costs for AE management were acquired from the 2019 US Healthcare Cost and Utilization Project National Inpatient Sample database. The rates of grade 3-5 AEs (with any-grade occurrence of 15%) were multiplied by those rates to determine AE expenses per patient.
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 period were similar in the N + I (2.6), N + I + LC (2.5), and N + C (2.5) tx groups (Table). In the following weeks, EAERs decreased further in all three tx groups. Similar patterns emerged throughout periods, with N + I costing $6,560 and N + I + LC costing $7,492 compared to N + C’s $11,731. Toxicities and expenses peaked when chemotherapy was provided, especially for N + I + LC and N + C compared to N + I, gradually decreasing once chemotherapy ended. The findings suggest that 1L N + I has a lower AE cost burden than IO + chemo-based tx regimens for aNSCLC.
Source: https://oncologypro.esmo.org/meeting-resources/esmo-congress/adverse-event-ae-burden-of-nivolumab-based-immuno-oncology-io-therapy-with-without-chemotherapy-chemo-for-first-line-1l-advanced-non-small
Clinical Trial:https://clinicaltrials.gov/ct2/show/NCT03215706
L.S. Schwartzberg, A. Wu, J. Hartman, T. Wang, X. Yin, J. Chen, K.A. Betts, S.J. Lubinga/Adverse event (AE) burden of nivolumab-based immuno-oncology (IO) therapy with/without chemotherapy (chemo) for first-line (1L) advanced non-small cell lung cancer (aNSCLC)/Annals of Oncology (2022) 33 (suppl_7): S448-S554. 10.1016/annonc/annonc1064
