The new analysis included 119 patients from another CheckMate-142 cohort who received nivolumab along with ipilimumab; the combination is already approved for use in metastatic melanoma. In this cohort, 76% of patients had received at least two prior systemic therapies, and they were followed for a median of 13.4 months. Results were published online ahead of print on January 20 in the Journal of Clinical Oncology.
A total of 65 patients (54.6%) achieved an objective response, including four complete responses (3.4%) and 61 partial responses (51.3%). Disease control for at least 12 weeks was achieved in 80% of patients, and 12% of patients had progressive disease as their best response. The median time to response was 2.8 months, and responses were durable; 94% had an ongoing response at the time of data cutoff. The median duration of response was not reached, and 83% had responses that lasted at least 6 months. Median progression-free survival (PFS) was not reached, and the 12-month PFS rate was 71%. Median overall survival (OS) was also not yet reached, with a 12-month OS rate of 85%.
The study also included patient-reported outcome (PRO) questionnaires. While on study, at least 60% of patients maintained functioning and global health status/quality of life (QOL) without worsening of symptoms based on the European Organisation for Research and Treatment of Cancer quality of life questionnaire C30 (EORTC QLQ-C30). Significant and clinically meaningful improvements from baseline were seen with regard to symptoms, functioning, and global health status/QOL by week 13 or earlier.
Treatment-related adverse events (TRAEs) were reported in 73% of patients, with 27% experiencing grade 3 TRAEs and 5% experiencing grade 4 TRAEs. The most common grade 3/4 TRAEs included elevated AST and/or ALT, elevated lipase, anemia, and colitis. TRAEs led to discontinuation of therapy in 13% of patients.