Nivolumab was associated with durable objective response rates (ORRs) in adults with relapsed or refractory classical Hodgkin lymphoma after autologous stem cell transplantation (ASCT), according to an extended follow-up analysis from the phase II CheckMate-205 clinical trial. The findings were presented at the 2017 International Conference on Malignant Lymphoma in Lugano, Switzerland.
“Treatment options are limited for patients with classical Hodgkin lymphoma after ASCT has failed, which is why the high objective response rates shown across cohorts of the CheckMate-205 study are encouraging,” said lead study author Michelle Fanale, MD, of the University of Texas MD Anderson Cancer Center in Houston. “The results are particularly welcome news, as patients experienced responses regardless of brentuximab vedotin treatment history or the depth of their Hodgkin lymphoma’s response to brentuximab vedotin.”
“Notably, with extended follow-up, both CRs [complete responses] and PRs [partial responses] remain durable,” they reported.
A total of 243 patients participated in the study in three cohorts; they received nivolumab 3 mg/kg every 2 weeks until tumor progression or unacceptable toxicity. Sixty-three patients were brentuximab vedotin–naïve (Cohort A). Cohort B included 80 patients administered brentuximab vedotin after ASCT. Cohort C included 100 patients administered brentuximab vedotin before ASCT, after ASCT, or both (n = 33, 58, and 9, respectively). In December 2016, at a median follow-up of 19, 23, and 16 months for the three cohorts, 40% of patients remained on treatment overall, the authors reported.
ORRs were 65% in brentuximab vedotin–naïve patients (Cohort A), compared with 68% in patients who received brentuximab vedotin after ASCT (Cohort B), and 73% in Cohort C. CR rates were 29%, 13%, and 12%, respectively.
Duration of response was 20 months, 16 months, and 15 months among patients in Cohorts A, B, and C.
“For patients with CR, duration of response was 20 months in brentuximab vedotin–naïve patients (Cohort A) and ≥ 15 months in brentuximab vedotin–treated patients (Cohorts B and C),” the authors reported.
Progression-free survival for cohorts A, B, and C were similar: 18.3 (95% CI, 11.1-22.4), 14.7 (95% CI, 10.5-19.6) and 11.9 (95% CI, 11.1-18.4). Overall survival was not yet calculable.
“The most common drug-related adverse events were fatigue (23%), diarrhea (15%), and infusion reactions (14%),” they reported.