Results of combined nivolumab and ipilimumab therapy in patients with cancer

Abstract

Introduction. The discovery of immune checkpoints and immune checkpoint inhibitors (ICI) became a breakthrough in medical oncology. Currently a search for most effective and safe schemes of ICI therapy for different cancers is ongoing.Aim. To evaluate the efficacy and tolerability of a combination of nivolumab and ipilimumab in cancer patients in real-life clinical practice.Materials and methods. The study included 30 patients: 13 patients with melanoma, 10 patients with renal cell carcinoma (RCC) and 7 patients with colorectal cancer (CRC). All patients underwent 4 courses of combined immune therapy (melanoma - nivolumab 1 mg/kg + ipilimumab 3 mg/kg; RCC, CRC – nivolumab 3 mg/kg + ipilimumab 1 mg/kg once per 21 days). Nivolumab monotherapy was continued after the achievement of disease control. Objective tumor response was registered in cases of partial or complete tumor regression. Treatment response was determined using iRECIST criteria.Results. Treatment effect assessment was performed in 91 patients. Complete response (CR) was registered in 1 (5%) patient, partial response (PR) – in 3 (16%) patients, disease stabilization – in 8 (42%) patients, unconfirmed progression – in 7 (37%) patients. No cases of disease progression were registered. Thus, objective response rate was 21%; disease control was achieved in 63% of patients. The most significant immune-mediated adverse effects (imAEs) were gastric toxicity (20%), 1–2 grade fatigue (13%) and 2–3 grade hepatotoxicity (10%).Conclusions. Combined nivolumab and ipilimumab therapy in patients with melanoma, CRC and RCC is associated with a high rate of disease control with acceptable toxicity profile.