TY - JOUR
T1 - ROSEWOOD
T2 - A Phase II Randomized Study of Zanubrutinib Plus Obinutuzumab Versus Obinutuzumab Monotherapy in Patients with Relapsed or Refractory Follicular Lymphoma
AU - Zinzani, Pier Luigi
AU - Mayer, Jiå
AU - Flowers, Christopher R.
AU - Bijou, Fontanet
AU - De Oliveira, Ana C.
AU - Song, Yuqin
AU - Zhang, Qingyuan
AU - Merli, Michele
AU - Bouabdallah, Krimo
AU - Ganly, Peter
AU - Zhang, Huilai
AU - Johnson, Roderick
AU - Martín García-Sancho, Alejandro
AU - Provencio Pulla, Mariano
AU - Trněný, Marek
AU - Yuen, Sam
AU - Tilly, Herve
AU - Kingsley, Edwin
AU - Tumyan, Gayane
AU - Assouline, Sarit E.
AU - Auer, Rebecca
AU - Ivanova, Elena
AU - Kim, Pil
AU - Huang, Sha
AU - Delarue, Richard
AU - Trotman, Judith
N1 - Publisher Copyright:
© American Society of Clinical Oncology.
PY - 2023/11/20
Y1 - 2023/11/20
N2 - PURPOSEThe combination of zanubrutinib plus obinutuzumab (ZO) was found to be well tolerated with an early signal of efficacy in a phase Ib study. ROSEWOOD is a phase II, randomized study that assessed the efficacy and safety of ZO versus obinutuzumab in patients with relapsed/refractory (R/R) follicular lymphoma (FL).METHODSPatients with R/R FL who had received â ‰¥2 lines of therapy, including an anti-CD20 antibody and an alkylating agent, were randomly assigned 2:1 to receive ZO or obinutuzumab (O). The primary end point was overall response rate (ORR) by independent central review (ICR). Secondary end points included duration of response (DOR), progression-free survival (PFS), overall survival, and safety.RESULTSA total of 217 patients were randomized (ZO, 145; O, 72). Median study follow-up was 20.2 months. The study met its primary end point: ORR by ICR was 69% (ZO) versus 46% (O; P =.001). Complete response rate was 39% (ZO) versus 19% (O); 18-month DOR rate was 69% (ZO) versus 42% (O). Median PFS was 28.0 months (ZO) versus 10.4 months (O; hazard ratio, 0.50 [95% CI, 0.33 to 0.75]; P <.001). The most common adverse events with ZO were thrombocytopenia, neutropenia, diarrhea, and fatigue; incidences of atrial fibrillation and major hemorrhage were 3% and 1%, respectively.CONCLUSIONThe combination of ZO met its primary end point of a superior ORR versus O, and demonstrated meaningful activity and a manageable safety profile in patients with R/R FL. ZO had a favorable benefit-risk profile compared with O, and represents a potential combination therapy for patients with R/R FL.
AB - PURPOSEThe combination of zanubrutinib plus obinutuzumab (ZO) was found to be well tolerated with an early signal of efficacy in a phase Ib study. ROSEWOOD is a phase II, randomized study that assessed the efficacy and safety of ZO versus obinutuzumab in patients with relapsed/refractory (R/R) follicular lymphoma (FL).METHODSPatients with R/R FL who had received â ‰¥2 lines of therapy, including an anti-CD20 antibody and an alkylating agent, were randomly assigned 2:1 to receive ZO or obinutuzumab (O). The primary end point was overall response rate (ORR) by independent central review (ICR). Secondary end points included duration of response (DOR), progression-free survival (PFS), overall survival, and safety.RESULTSA total of 217 patients were randomized (ZO, 145; O, 72). Median study follow-up was 20.2 months. The study met its primary end point: ORR by ICR was 69% (ZO) versus 46% (O; P =.001). Complete response rate was 39% (ZO) versus 19% (O); 18-month DOR rate was 69% (ZO) versus 42% (O). Median PFS was 28.0 months (ZO) versus 10.4 months (O; hazard ratio, 0.50 [95% CI, 0.33 to 0.75]; P <.001). The most common adverse events with ZO were thrombocytopenia, neutropenia, diarrhea, and fatigue; incidences of atrial fibrillation and major hemorrhage were 3% and 1%, respectively.CONCLUSIONThe combination of ZO met its primary end point of a superior ORR versus O, and demonstrated meaningful activity and a manageable safety profile in patients with R/R FL. ZO had a favorable benefit-risk profile compared with O, and represents a potential combination therapy for patients with R/R FL.
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U2 - 10.1200/JCO.23.00775
DO - 10.1200/JCO.23.00775
M3 - Article
C2 - 37506346
AN - SCOPUS:85179075207
SN - 0732-183X
VL - 41
SP - 5107
EP - 5117
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 33
ER -