Phase II single-arm study of brentuximab vedotin in Chinese patients with relapsed/refractory classical Hodgkin lymphoma or systemic anaplastic large cell lymphoma.

Background Relapsed/refractory (R/R) classical HL (cHL) and systemic anaplastic large-cell lymphoma (sALCL) treatment options are limited in China and there is a need for new therapies. Research design and methods This single-arm, open-label, multicenter, Phase II study assessed efficacy, safety, and pharmacokinetics (PK) of single-agent brentuximab vedotin in Chinese patients with R/R cHL or sALCL. Patients received brentuximab vedotin as a 1.8 mg/kg intravenous infusion on Day 1 of a 3-week cycle (maximum 16 cycles). Results Patients (N=39) received a median of 10 cycles (range: 2-16) of brentuximab vedotin. The objective response rate was 69% (95% CI: 52-83%). Median duration of response, progression-free survival and overall survival were 12.1 months, 13.5 months (95% CI: 6.8 months-not estimable) and not reached after a median follow-up of 16.6 months. Twenty seven (69%) patients achieved an objective response (complete response: n=11 [28%]; partial response: n=16 [41%]). Brentuximab vedotin was well-tolerated with no on-study deaths. AEs were generally manageable and reversible. No new safety signals were identified. PK were consistent with those previously described in Western populations. Conclusion Brentuximab vedotin had a positive benefit-risk profile for Chinese patients with R/R cHL or sALCL confirming it as a potential treatment option. Clinical trial registration www.clinicaltrials.gov identifier is NCT02939014.