Real-World Adoption of Adjuvant Immune Checkpoint Inhibition in Stage IIB/IIC Melanoma Following FDA Approval.

Abstract

Background: Adjuvant immune checkpoint inhibition (ICI) for stage IIB/IIC melanoma was approved in December 2021 based on recurrence-free survival benefit without mature overall survival data. Given uncertainty regarding the risk-benefit balance in this population, we evaluated real-world utilization of adjuvant ICI in the first year following FDA approval and compared uptake with historical patterns observed in stage III melanoma.

Methods: The National Cancer Database (NCDB) and Mayo Clinic Cancer Registry were queried for patients with stage IIB/IIC melanoma diagnosed in 2019-2020 (pre-approval) and 2022 (post-approval). Utilization was compared with historical patterns for stage III melanoma surrounding its December 2017 FDA approval. Multivariable logistic regression identified factors associated with receipt of adjuvant ICI.

Results: Among 7039 patients with stage IIB/IIC melanoma in NCDB, adjuvant ICI use increased from 5% pre-approval to 32% post-approval (P < .0001), with higher utilization in stage IIC (40%) than IIB (27%). Younger age was the only consistent patient-level factor associated with treatment. Within our tertiary care system, 21% of eligible patients received adjuvant ICI post-approval. By comparison, stage III utilization at NCDB sites increased from 27 to 58% in the first year following its FDA approval.

Conclusions: Adjuvant ICI use for stage IIB/IIC melanoma increased following FDA approval; however, most eligible patients did not receive therapy, and overall utilization remained lower than historical patterns observed for stage III disease, suggesting selective adoption driven by risk-benefit considerations.