As reported by Armand and colleagues in the Journal of Clinical Oncology, extended follow-up of the phase II CheckMate 205 trial continues to show benefits and good tolerability of nivolumab (Opdivo) treatment in relapsed or refractory classical Hodgkin lymphoma after failure of autologous hematopoietic cell transplantation (HCT). The trial supported the 2016 approval of nivolumab in classical Hodgkin lymphoma.
In CheckMate 205, 243 patients with relapsed/refractory disease after autologous HCT enrolled between August 2014 and August 2015 were categorized into three cohorts according to treatment history: brentuximab vedotin (Adcetris)-naive (cohort A, n = 63), failure of post–autologous HCT brentuximab vedotin treatment (cohort B, n = 80), and brentuximab vedotin treatment before and/or after autologous HCT failure (cohort C, n = 100). All patients received nivolumab at 3 mg/kg every 2 weeks until disease progression or unacceptable toxicity; a protocol amendment allowed patients to continue treatment beyond investigator-assessed progression if ongoing clinical benefit was observed.
The primary endpoint was objective response rate assessed by independent radiology review committee.
After median follow-up of 18 months, 40% of patients continued to receive treatment. The objective response rate was 69% overall, including 65% in cohort A, 68% in cohort B, and 73% in cohort C.
Median time to first objective response was 2.1 months among all patients. Median duration of response was 16.6 months overall, including 20.3, 15.9, and 14.5 months in cohorts A, B, and C, respectively.
Median progression-free survival was 14.7 months, including 18.3, 14.7, and 11.9 months in cohorts A, B, and C, respectively. A total of 70 patients were treated beyond conventional disease progression; among 51 with evaluable postprogression data, 61% exhibited stable or reduced target tumor burden.
The most common grade 3 or 4 drug-related adverse events were increased lipase (5%), neutropenia (3%), and increased alanine transaminase levels (3%). Serious drug-related adverse events occurred in 12% of patients, including infusion-related reactions (2%), pneumonitis (1%), pneumonia (1%), pleural effusion (1%), and pyrexia (1%). The most common immune-mediated adverse events of any grade were hypothyroidism/thyroiditis (12%) and rash (9%).
Drug-related adverse events led to treatment discontinuation in 7% of patients, with the most common causes being pneumonitis (2%) and autoimmune hepatitis (1%). No treatment-related deaths were reported.
The investigators concluded, “With extended follow-up, responses to nivolumab were frequent and durable. Nivolumab seems to be associated with a favorable safety profile and long-term benefits across a broad spectrum of patients with relapsed/refractory [classic Hodgkin lymphoma].”
The study was supported by Bristol-Myers Squibb.
Philippe Armand, MD, of Dana-Farber Cancer Institute, is the corresponding author for the Journal of Clinical Oncology article.
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