Abstract
Background
Many patients with classical Hodgkin lymphoma show increased programmed death-1 ligand expression in Reed–Sternberg cells. We report the final results of a phase II study of nivolumab, an anti-programmed death-1 monoclonal antibody, in Japanese patients with relapsed or refractory classical Hodgkin lymphoma.
Methods
Japanese patients with previously treated classical Hodgkin lymphoma (aged ≥ 20 years) were administered nivolumab (3 mg/kg on Day 1 of 14-day cycles) until progressive disease, an unacceptable adverse event, or another clinically relevant reason. Treatment could continue beyond progressive disease at the investigator’s discretion in selected patients.
Results
Seventeen patients (median age: 63.0 years) were enrolled. The median follow-up was 38.8 months. One patient with non-Hodgkin lymphoma was excluded from efficacy analyses. The centrally assessed overall response rate in 16 classical Hodgkin lymphoma patients was 87.5% (95% confidence interval = 61.7–98.4%) and the disease control rate was 93.8% (95% confidence interval = 69.8–99.8%). The median (95% confidence interval) duration of response and progression-free survival were 8.5 (2.4–12.6) and 11.7 (1.8–42.3) months, respectively. The 3-year overall survival rate was 80.4% (95% confidence interval = 50.6–93.2%). Nivolumab was continued beyond progressive disease in seven patients; six were alive at the data cut-off. Adverse drug reactions occurred in all 17 patients with grades 3–4 adverse drug reactions in eight patients and no grade 5 adverse drug reactions. Pulmonary toxicities occurred in five patients; four of these occurred ≥17 months after starting nivolumab.
Conclusion
Nivolumab is effective and tolerable in Japanese relapsed or refractory classical Hodgkin lymphoma patients. Continued monitoring may be necessary to detect late-onset pulmonary toxicities.
Clinical trial registration
JapicCTI-142755 (Japan Pharmaceutical Information Center).
Multicenter phase II study of nivolumab in Japanese patients with relapsed or refractory classical Hodgkin lymphoma
