{Reference Type}: Journal Article
{Title}: Phase II single-arm study of brentuximab vedotin in Chinese patients with relapsed/refractory classical Hodgkin lymphoma or systemic anaplastic large cell lymphoma.
{Author}: Song Y;Guo Y;Huang H;Li W;Ke X;Feng J;Xu W;Miao H;Kinley J;Song G;Dai Y;Wang H;Zhu J;
{Journal}: Expert Rev Hematol
{Volume}: 14
{Issue}: 9
{Year}: Sep 2021
{Factor}: 2.819
{DOI}: 10.1080/17474086.2021.1942831
{Abstract}: <B>UNASSIGNED: </B>Relapsed/refractory (R/R) classical HL (cHL) and systemic anaplastic large-cell lymphoma (sALCL) treatment options are limited in China. There is a need for new therapies.<BR><B>UNASSIGNED: </B>This single-arm, open-label, multicenter, Phase II study assessed efficacy, safety, and pharmacokinetics of single-agent brentuximab vedotin in Chinese patients with R/R cHL or sALCL. Patients received brentuximab vedotin 1.8 mg/kg by intravenous infusion on Day 1 of 3-week cycles (maximum 16 cycles).<BR><B>UNASSIGNED: </B>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%), with 27 patients achieving objective responses (complete response: n = 11 [28%]; partial response: n = 16 [41%]). 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. Brentuximab vedotin was well tolerated with no on-study deaths. AEs were generally manageable and reversible. No new safety signals were identified. Pharmacokinetics were consistent with those previously described in Western populations.<BR><B>UNASSIGNED: </B>Brentuximab vedotin had a positive benefit-risk profile for Chinese patients with R/R cHL or sALCL, confirming it as a potential treatment option.<BR><B>UNASSIGNED: </B>www.clinicaltrials.gov identifier is NCT02939014.