ROSEWOOD: A Phase II Randomized Study of Zanubrutinib Plus
Obinutuzumab Versus Obinutuzumab Monotherapy in Patients With
Relapsed or Refractory Follicular Lymphoma

J 2023

ROSEWOOD: A Phase II Randomized Study of Zanubrutinib Plus Obinutuzumab Versus Obinutuzumab Monotherapy in Patients With Relapsed or Refractory Follicular Lymphoma

ZINZANI, Pier Luigi, Jiří MAYER, Christopher R FLOWERS, Fontanet BIJOU, Ana C De OLIVEIRA et. al.

Basic information

Original name

ROSEWOOD: A Phase II Randomized Study of Zanubrutinib Plus Obinutuzumab Versus Obinutuzumab Monotherapy in Patients With Relapsed or Refractory Follicular Lymphoma

Authors

ZINZANI, Pier Luigi, Jiří MAYER (203 Czech Republic, belonging to the institution), Christopher R FLOWERS, Fontanet BIJOU, Ana C De OLIVEIRA, Yuqin SONG, Qingyuan ZHANG, Michele MERLI, Krimo BOUABDALLAH, Peter GANLY, Huilai ZHANG, Roderick JOHNSON, Alejandro Martín GARCÍA-SANCHO, Mariano Provencio PULLA, Marek TRNĚNÝ, Sam YUEN, Herve TILLY, Edwin KINGSLEY, Gayane TUMYAN, Sarit E ASSOULINE, Rebecca AUER, Elena IVANOVA, Pil KIM, Sha HUANG, Richard DELARUE and Judith TROTMAN

Edition

Journal of Clinical Oncology, PHILADELPHIA, LIPPINCOTT WILLIAMS & WILKINS, 2023, 0732-183X

Other information

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30205 Hematology

Country of publisher

United States of America

Confidentiality degree

není předmětem státního či obchodního tajemství

References:

URL

Impact factor

Impact factor: 45.300 in 2022

RIV identification code

RIV/00216224:14110/23:00132497

Organization unit

Faculty of Medicine

DOI

http://dx.doi.org/10.1200/JCO.23.00775

UT WoS

001112781400018

Keywords in English

Zanubrutinib; Obinutuzumab; Refractory Follicular Lymphoma

Abstract

V originále

Purpose: The 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). Methods: Patients with R/R FL who had received ≥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. Results: A 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. Conclusion: The 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.

Citovat

ZINZANI, Pier Luigi, Jiří MAYER, Christopher R FLOWERS, Fontanet BIJOU, Ana C De OLIVEIRA, Yuqin SONG, Qingyuan ZHANG, Michele MERLI, Krimo BOUABDALLAH, Peter GANLY, Huilai ZHANG, Roderick JOHNSON, Alejandro Martín GARCÍA-SANCHO, Mariano Provencio PULLA, Marek TRNĚNÝ, Sam YUEN, Herve TILLY, Edwin KINGSLEY, Gayane TUMYAN, Sarit E ASSOULINE, Rebecca AUER, Elena IVANOVA, Pil KIM, Sha HUANG, Richard DELARUE and Judith TROTMAN. ROSEWOOD: A Phase II Randomized Study of Zanubrutinib Plus Obinutuzumab Versus Obinutuzumab Monotherapy in Patients With Relapsed or Refractory Follicular Lymphoma. Journal of Clinical Oncology. PHILADELPHIA: LIPPINCOTT WILLIAMS & WILKINS, 2023, vol. 41, No 33, p. 5107-5117, 13 pp. ISSN 0732-183X. Available from: https://dx.doi.org/10.1200/JCO.23.00775.

@article{2348897,
   author = {Zinzani, Pier Luigi and Mayer, Jiří and Flowers, Christopher R and Bijou, Fontanet and Oliveira, Ana C De and Song, Yuqin and Zhang, Qingyuan and Merli, Michele and Bouabdallah, Krimo and Ganly, Peter and Zhang, Huilai and Johnson, Roderick and GarcíaandSancho, Alejandro Martín and Pulla, Mariano Provencio and Trněný, Marek and Yuen, Sam and Tilly, Herve and Kingsley, Edwin and Tumyan, Gayane and Assouline, Sarit E and Auer, Rebecca and Ivanova, Elena and Kim, Pil and Huang, Sha and Delarue, Richard and Trotman, Judith},
   article_location = {PHILADELPHIA},
   article_number = {33},
   doi = {http://dx.doi.org/10.1200/JCO.23.00775},
   keywords = {Zanubrutinib; Obinutuzumab; Refractory Follicular Lymphoma},
   language = {eng},
   issn = {0732-183X},
   journal = {Journal of Clinical Oncology},
   title = {ROSEWOOD: A Phase II Randomized Study of Zanubrutinib Plus Obinutuzumab Versus Obinutuzumab Monotherapy in Patients With Relapsed or Refractory Follicular Lymphoma},
   url = {https://ascopubs.org/doi/10.1200/JCO.23.00775},
   volume = {41},
   year = {2023}
}

TY  - JOUR
ID  - 2348897
AU  - Zinzani, Pier Luigi - Mayer, Jiří - Flowers, Christopher R - Bijou, Fontanet - Oliveira, Ana C De - Song, Yuqin - Zhang, Qingyuan - Merli, Michele - Bouabdallah, Krimo - Ganly, Peter - Zhang, Huilai - Johnson, Roderick - García-Sancho, Alejandro Martín - Pulla, Mariano Provencio - Trněný, Marek - Yuen, Sam - Tilly, Herve - Kingsley, Edwin - Tumyan, Gayane - Assouline, Sarit E - Auer, Rebecca - Ivanova, Elena - Kim, Pil - Huang, Sha - Delarue, Richard - Trotman, Judith
PY  - 2023
TI  - ROSEWOOD: A Phase II Randomized Study of Zanubrutinib Plus Obinutuzumab Versus Obinutuzumab Monotherapy in Patients With Relapsed or Refractory Follicular Lymphoma
JF  - Journal of Clinical Oncology
VL  - 41
IS  - 33
SP  - 5107-5117
EP  - 5107-5117
PB  - LIPPINCOTT WILLIAMS & WILKINS
SN  - 0732183X
KW  - Zanubrutinib
KW  - Obinutuzumab
KW  - Refractory Follicular Lymphoma
UR  - https://ascopubs.org/doi/10.1200/JCO.23.00775
N2  - Purpose: The 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). Methods: Patients with R/R FL who had received ≥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. Results: A 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. Conclusion: The 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.
ER  -

ZINZANI, Pier Luigi, Jiří MAYER, Christopher R FLOWERS, Fontanet BIJOU, Ana C De OLIVEIRA, Yuqin SONG, Qingyuan ZHANG, Michele MERLI, Krimo BOUABDALLAH, Peter GANLY, Huilai ZHANG, Roderick JOHNSON, Alejandro Martín GARCÍA-SANCHO, Mariano Provencio PULLA, Marek TRNĚNÝ, Sam YUEN, Herve TILLY, Edwin KINGSLEY, Gayane TUMYAN, Sarit E ASSOULINE, Rebecca AUER, Elena IVANOVA, Pil KIM, Sha HUANG, Richard DELARUE and Judith TROTMAN. ROSEWOOD: A Phase II Randomized Study of Zanubrutinib Plus Obinutuzumab Versus Obinutuzumab Monotherapy in Patients With Relapsed or Refractory Follicular Lymphoma. \textit{Journal of Clinical Oncology}. PHILADELPHIA: LIPPINCOTT WILLIAMS \&{} WILKINS, 2023, vol.~41, No~33, p.~5107-5117, 13 pp. ISSN~0732-183X. Available from: https://dx.doi.org/10.1200/JCO.23.00775.

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