Informace o publikaci

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

Autoři	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
Rok publikování	2023
Druh	Článek v odborném periodiku
Časopis / Zdroj	Journal of Clinical Oncology
Fakulta / Pracoviště MU	Lékařská fakulta
Citace
www	https://ascopubs.org/doi/10.1200/JCO.23.00775
Doi	http://dx.doi.org/10.1200/JCO.23.00775
Klíčová slova	Zanubrutinib; Obinutuzumab; Refractory Follicular Lymphoma
Popis	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.