Aims: In a phase 3 trial (CheckMate 067), NIVO and IPI combination showed longer progression-free survival in patients with MEL, although treatment-related grade 3/4 adverse events (AEs) were more common with NIVO+IPI than with NIVO or IPI. We report safety data from an EAP of NIVO+IPI in MEL patients (CheckMate 218).
Methods: Patients received NIVO 1 mg/kg + IPI 3 mg/kg Q3W x 4, then NIVO 3 mg/kg Q2W until progression or up to 48 weeks. Assessments included incidence of treatment-related AEs and select (immune-related) AEs from the first 6 months (database lock: November 2015).
Results: Among 252 patients, median age was 59 years, 68% were male, 29% received ≥1 prior therapy, 98% had ECOG PS of 0-1, 77% had stage IV MEL, and 50% had M1c. Median number of NIVO and IPI doses received were 3.5 (1-22) and 3 (1-4), respectively. After treatment with NIVO+IPI, 39% patients continued to receive NIVO alone. 106/252 pts (42%) are still on treatment. Treatment-related AEs of any grade were reported in 93% patients and grade 3/4 in 52%. The most common grade 3/4 select AEs were gastrointestinal (18%) and hepatic (14%). Less common were skin (3%), renal (2%), and endocrine (2%) AEs; pancreatitis and pneumonitis occurred at <1%. No treatment-related deaths were reported. Median time to onset for treatment-related grade 3/4 gastrointestinal and hepatic AEs was 6.6 (0.4-16.1) and 8.6 (1.0-17.0) weeks, respectively. Treatment-related grade 3/4 AEs leading to discontinuation were reported in 23% patients.
Conclusions:In this EAP, patient demographics were similar to those reported in CheckMate 067, except that there were patients in the EAP who received prior therapies for MEL. The overall safety profile was consistent with prior clinical trial.