In the phase I/II CheckMate 032 study, nivolumab (Opdivo) alone and with ipilimumab (Yervoy) demonstrated activity in patients with small cell lung cancer (SCLC) progressing after at least one previous platinum regimen, as reported in The Lancet Oncology by Antonia et al.
Study Details
In the SCLC cohort of the open-label study, 216 patients with limited-stage or extensive-stage disease received nivolumab at 3 mg/kg every 2 weeks (n = 98) or combinations of nivolumab at 1 mg/kg plus ipilimumab at 1 mg/kg (n = 3); nivolumab at 1 mg/kg plus ipilimumab at 3 mg/kg (n = 61); and nivolumab at 3 mg/kg plus ipilimumab at 1 mg/kg (n = 54) every 3 weeks for 4 cycles followed by nivolumab at 3 mg/kg every 2 weeks.
Response Rates
The objective response was observed in 10 of 98 patients (10%) receiving nivolumab at 3 mg/kg, 1 of 3 patients (33%) receiving nivolumab at 1 mg/kg plus ipilimumab at 1 mg/kg, 14 of 61 patients (23%) receiving nivolumab at 1 mg/kg plus ipilimumab at 3 mg/kg, and 10 of 54 patients (19%) receiving nivolumab at 3 mg/kg plus ipilimumab at 1 mg/kg. The median duration of response was not reached in the nivolumab monotherapy group, 7.7 months in the nivolumab at 1 mg/kg plus ipilimumab at 3 mg/kg group, and 4.4 months in the nivolumab at 3 mg/kg plus ipilimumab at 1 mg/kg group. In total, 16 patients had responses > 6 months.
Toxicity
Grade 3 or 4 treatment-related adverse events occurred in 13% of patients in the nivolumab 3 mg/kg group, 30% of the nivolumab 1 mg/kg plus ipilimumab 3 mg/kg group, and 19% of the nivolumab 3 mg/kg plus ipilimumab 1 mg/kg group, with the most common being increased lipase (0%, 8%, 0%) and diarrhea (0%, 5%, 2%). Treatment was discontinued due to adverse events in 6%, 11%, and 7% of patients. Death due to treatment-related adverse events occurred in two patients in the nivolumab at 1 mg/kg plus ipilimumab at 3 mg/kg group and in one patient in the nivolumab at 3 mg/kg plus ipilimumab at 1 mg/kg group.
“The investigators concluded: Nivolumab monotherapy and nivolumab plus ipilimumab showed antitumour activity with durable responses and manageable safety profiles in previously treated patients with SCLC. These data suggest a potential new treatment approach for a population of patients with limited treatment options and support the evaluation of nivolumab and nivolumab plus ipilimumab in phase 3 randomised controlled trials in SCLC.”
The study was funded by Bristol-Myers Squibb. ■
Antonia SJ, et al: Lancet Oncol 17:883-895, 2016.
