Final analyses from the ALCANZA study, a phase III trial investigating brentuximab vedotin vs physician’s choice for the treatment of CD30-positive cutaneous T-cell lymphoma (CTCL), were presented by Horwitz et al at the 15th International Conference on Malignant Lymphoma (ICML; Abstract 232).
ALCANZA Initial Data
Adults with previously treated CD30-positive mycosis fungoides or primary cutaneous anaplastic large cell lymphoma were randomly assigned 1:1 to receive treatment with either brentuximab vedotin or physician’s choice. The original analysis of ALCANZA data, published by Prince et al in The Lancet, showed improvements in objective response and progression-free survival with brentuximab vedotin treatment vs physician’s choice.
Final trial data were presented at ICML.
Final results demonstrated improved efficacy with brentuximab vedotin vs physician’s choice. Median progression-free survival was 16.7 months with brentuximab vedotin vs 3.5 months with physician’s choice (P < .0001). Median time to next therapy was 14.2 months in the brentuximab vedotin arm vs 5.6 months in the physician’s choice arm (hazard ratio [HR] = 0.269, 95% confidence interval [CI] = 0.171–0.424, P < .001). Seventy-eight percent of patients in the brentuximab vedotin arm received subsequent antineoplastic therapy vs 75% in the physician’s choice arm; 24% of patients were retreated with brentuximab vedotin and 69% received brentuximab vedotin after physician’s choice. The probability of not requiring subsequent anticancer therapy was 65.5% at 1 year and 23.6% at 2 years in the brentuximab vedotin arm.
There were 23 deaths in the brentuximab vedotin arm and 25 in the physician’s choice arm (HR = 0.754, 95% CI = 0.421–1.318, P = .310).
Sixty-seven percent of patients treated with brentuximab vedotin experienced peripheral neuropathy; most events were grade 1 or 2. Eighty-six percent of patients who had a peripheral neuropathy event had complete resolution or improvement, compared with 82% in the original ALCANZA analysis.
The researchers concluded, “Final analyses from ALCANZA confirm improved, durable responses and longer progression-free survival with brentuximab vedotin vs physician’s choice in CD30-positive cutaneous T-cell lymphoma. Brentuximab vedotin demonstrated extended time to next treatment vs physician’s choice, suggesting that durable brentuximab vedotin responses were clinically meaningful. Peripheral neuropathy is ongoing in 27% of patients treated with brentuximab vedotin, but is all grade 1/2.”
Disclosure: For full disclosures of the study authors, visit lymphcon.ch.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.