15-ICML: Final Data From ALCANZA: Brentuximab Vedotin for CD30-Positive CTCL
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 Data
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).
Safety
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.
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