Photo Credit: yumiyum

The following is a summary of “Comparative Analysis of Intracranial Response Assessment Criteria in Patients With Melanoma Brain Metastases Treated With Combination Nivolumab + Ipilimumab in CheckMate 204,” published in the January 2025 issue of Oncology by Huang et al.

This exploratory analysis aimed to evaluate various intracranial (IC) response criteria to determine the most reliable surrogate for OS in patients with melanoma brain metastases (MBMs) treated with nivolumab and ipilimumab, as reported in the CheckMate 204 trial. In this trial, 119 patients with at least one unirradiated MBM received a combination of nivolumab and ipilimumab every three weeks for four doses, followed by nivolumab every two weeks for up to 24 months. The IC objective response rate (icORR) was assessed through several criteria, including modified RECIST (mRECIST), Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) with 5 mm and 10 mm cutoffs, and volumetric criteria with similar cutoffs. A six-week response landmark was used to compare IC progression-free survival (icPFS) and OS between responders and nonresponders

The results revealed that icORR was higher when assessed using mRECIST and volumetric criteria compared to RANO-BM or standard RECIST criteria. Additionally, mRECIST and volumetric responses exhibited stronger correlations with icPFS and OS. Notably, mRECIST responders who were nonresponders under the 5 mm RANO-BM criteria (n = 14) had OS outcomes comparable to those categorized as responders under RANO-BM 5 mm (n = 41). It was observed that clinical deterioration could influence RANO-BM icORR; however, when focusing solely on radiographic assessments without clinical deterioration, the RANO-BM 5 mm criteria performed similarly to mRECIST. Furthermore, among 41 patients with all target lesions measuring less than 10 mm, the icPFS and OS of responders were similar to those of the broader responder population, suggesting accurate response determination even in patients with smaller MBMs.

The findings of this analysis underscore the reliability of mRECIST and radiographic-only RANO-BM 5 mm as effective assessment scales in MBM trials. The strong correlation of volumetric response with survival outcomes supports its potential application in future trials. Moreover, the ability to accurately determine response in patients with MBMs less than 10 mm suggests that including patients with MBMs as small as 5 mm in future trials could be feasible and beneficial.

Source: ascopubs.org/doi/10.1200/JCO.24.00953