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

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.