Patients with advanced melanoma may have good outcomes when treated with standard-dose pembrolizumab with 4 doses of reduced-dose ipilimumab, according to a study published in The Lancet Oncology.1
Previous studies demonstrated that combining standard-dose ipilimumab and reduced-dose nivolumab improved objective response (OR) and progression-free survival (PFS) in patients with advanced melanoma, but had increased toxicity.
The phase 1b KEYNOTE-029 trial (ClinicalTrials.gov Identifier: NCT02089685) enrolled 153 patients with advanced melanoma who were immune checkpoint inhibitor–naive to receive intravenous (IV) pembrolizumab 2 mg/kg plus IV ipilimumab 1mg/kg every 3 weeks for 4 doses, followed by IV pembrolizumab 2 mg/kg every 3 weeks for up to 2 years.
The primary outcomes were safety and tolerability, and secondary endpoints included objective response and overall survival (OS).
Of the 153 patients, 72% received all 4 doses of the pembrolizumab plus ipilimumab combination, and 42% remained on pembrolizumab therapy. Forty-five percent of patients experienced grade 3 to 4 treatment-related adverse effects (AE), which led to discontinuation in 14% of patients. Ipilimumab was discontinued by only 8% of patients, and pembrolizumab was discontinued by only 9% of patients due to AEs.
OR was observed in 61% (95% CI, 53%-69%) of patients. One-year OS was 89% (95% CI, 83%-93%); 1-year PFS was 69% (95% CI, 60%-75%).
No treatment-related deaths were observed.
The authors concluded that “standard-dose pembrolizumab plus reduced-dose ipilimumab might be a tolerable, efficacious treatment option for patients with advanced melanoma.”
- Long GV, Atkinson V, Cebon JS, et al. Standard-dose pembrolizumab in combination with reduced-dose ipilimumab for patients with advanced melanoma (KEYNOTE-029): an open-label, phase 1b trial. Lancet Oncology. 2017 Jul 17. doi: 10.1016/S1470-2045 [Epub ahead of print]