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March 18, 2024
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Article

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

Publicated to: Journal Of Clinical Oncology. 41 (33): 5107-+ - 2023-11-20 41(33), DOI: 10.1200/JCO.23.00775

Authors: Zinzani, PL; Mayer, J; Flowers, CR; Bijou, F; De Oliveira, AC; Song, YQ; Zhang, QY; Merli, M; Bouabdallah, K; Ganly, P; Zhang, HL; Johnson, R; Garcia-Sancho, AM; Pulla, MP; Trneny, M; Yuen, S; Tilly, H; Kingsley, E; Tumyan, G; Assouline, SE; Auer, R; Ivanova, E; Kim, P; Huang, S; Delarue, R; Trotman, J

Affiliations

Barts Hlth NHS Trust, St Bartholomews Hosp, London, England - Author
BeiGene Shanghai Co Ltd, Shanghai, Peoples R China - Author
BeiGene Switzerland GmbH, Basel, Switzerland - Author
BeiGene USA Inc, San Mateo, CA USA - Author
Calvary Mater Newcastle, Waratah, NSW, Australia - Author
Christchurch Hosp, Dept Haematol, Christchurch, New Zealand - Author
CHU Bordeaux, Hop Haut Leveque, Pessac, France - Author
Comprehens Canc Ctr Nevada, Las Vegas, NV USA - Author
Harbin Med Univ Canc Hosp, Harbin, Peoples R China - Author
Henri Becquerel Ctr, Rouen, France - Author
Hosp Barcelona, Inst Catala Oncol, Hosp Duran & Reynals, Barcelona, Spain - Author
Hosp Univ Puerta Hierro Majadahonda, Madrid, Spain - Author
Hosp Univ Salamanca, Dept Hematol, CIBERONC, IBSAL, Salamanca, Spain - Author
Inst Bergonie, Bordeaux, France - Author
Masaryk Univ, Dept Internal Med Hematol & Oncol, Brno, Czech Republic - Author
McGill Univ, Jewish Gen Hosp, Montreal, PQ, Canada - Author
NN Blokhin Russian Canc Res Ctr, Moscow, Russia - Author
Peking Univ Canc Hosp & Inst, Beijing, Peoples R China - Author
St James Univ Hosp, Leeds Teaching Hosp NHS Trust, Leeds, W Yorkshire, England - Author
Tianjin Med Univ Canc Inst & Hosp, Tianjin, Peoples R China - Author
Univ Bologna, Dipartimento Sci Med & Chirurg, Bologna, Italy - Author
Univ Bologna, Ist Ematol Seragnoli, IRCCS Azienda Osped Univ Bologna, Bologna, Italy - Author
Univ Hosp Osped Circolo, Hematol, Varese, Italy - Author
Univ Hosp, Brno, Czech Republic - Author
Univ Insubria, Fdn Macchi ASST Sette Laghi, Varese, Italy - Author
Univ Sydney, Concord Repatriat Gen Hosp, Concord, NSW, Australia - Author
Univ Texas MD Anderson Canc Ctr, Dept Lymphoma Myeloma, Houston, TX USA - Author
Vseobecna Fak Nemocnice Praze, Nove Mesto, Czech Republic - Author
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Abstract

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.

Keywords

AdultAgedAlkylating agentAllogeneic hematopoietic stem cell transplantationAnemiaAnthracyclineAntibodies, monoclonal, humanizedAntineoplastic agentAntineoplastic combined chemotherapy protocolsAstheniaAtrial fibrillationBackacheBendamustineCancer immunotherapyCancer patientCancer recurrenceCancer survivalCd20 antibodyChronic lymphocytic-leukemiaClinical trialCombination drug therapyConference paperCopanlisibCyclophosphamideDrug efficacyDrug safetyDrug withdrawalDyspneaErythrocyte transfusionFatigueFebrile neutropeniaFemaleFeverFollicular lymphomaFollow upGa101Granulocyte colony stimulating factorHemoptysisHerpes zosterHumanHumansHypertensionIbrutinibInfectionInfusion related reactionInhibitionLenalidomideLine of treatmentLymphoma, follicularMajor clinical studyMaleMedian survival timeMonoclonal antibodyMonotherapyMulticenterMultiple cycle treatmentNeutropeniaNon-hodgkin-lymphomaObinutuzumabOpen-labelOverall response rateOverall survivalPetechiaPhase 1 clinical trialPhase 2 clinical trialPhosphatidylinositol 3 kinase inhibitorPiperidine derivativePiperidinesPneumoniaProgression free survivalPyrazole derivativePyrazolesPyrimidine derivativePyrimidinesRandomized controlled trialRefractory cancerRetroperitoneal hematomaRituximabSurvivalSystemic therapyThrombocytopeniaTreatment responseUrinary tract infectionZanubrutinib

Quality index

Bibliometric impact. Analysis of the contribution and dissemination channel

The work has been published in the journal Journal Of Clinical Oncology due to its progression and the good impact it has achieved in recent years, according to the agency WoS (JCR), it has become a reference in its field. In the year of publication of the work, 2023, it was in position 6/322, thus managing to position itself as a Q1 (Primer Cuartil), in the category Oncology. Notably, the journal is positioned above the 90th percentile.

From a relative perspective, and based on the normalized impact indicator calculated from World Citations provided by WoS (ESI, Clarivate), it yields a value for the citation normalization relative to the expected citation rate of: 3.99. This indicates that, compared to works in the same discipline and in the same year of publication, it ranks as a work cited above average. (source consulted: ESI Nov 13, 2025)

This information is reinforced by other indicators of the same type, which, although dynamic over time and dependent on the set of average global citations at the time of their calculation, consistently position the work at some point among the top 50% most cited in its field:

  • Weighted Average of Normalized Impact by the Scopus agency: 2.78 (source consulted: FECYT Mar 2025)

Specifically, and according to different indexing agencies, this work has accumulated citations as of 2025-12-13, the following number of citations:

  • WoS: 22
  • Scopus: 20
  • Europe PMC: 6

Impact and social visibility

From the perspective of influence or social adoption, and based on metrics associated with mentions and interactions provided by agencies specializing in calculating the so-called "Alternative or Social Metrics," we can highlight as of 2025-12-13:

  • The use, from an academic perspective evidenced by the Altmetric agency indicator referring to aggregations made by the personal bibliographic manager Mendeley, gives us a total of: 51.
  • The use of this contribution in bookmarks, code forks, additions to favorite lists for recurrent reading, as well as general views, indicates that someone is using the publication as a basis for their current work. This may be a notable indicator of future more formal and academic citations. This claim is supported by the result of the "Capture" indicator, which yields a total of: 52 (PlumX).

With a more dissemination-oriented intent and targeting more general audiences, we can observe other more global scores such as:

  • The Total Score from Altmetric: 50.
  • The number of mentions on the social network Facebook: 1 (Altmetric).
  • The number of mentions on the social network X (formerly Twitter): 22 (Altmetric).
  • The number of mentions in news outlets: 5 (Altmetric).

It is essential to present evidence supporting full alignment with institutional principles and guidelines on Open Science and the Conservation and Dissemination of Intellectual Heritage. A clear example of this is:

  • The work has been submitted to a journal whose editorial policy allows open Open Access publication.

Leadership analysis of institutional authors

This work has been carried out with international collaboration, specifically with researchers from: Australia; Canada; China; Czech Republic; France; Italy; New Zealand; Russia; Switzerland; United Kingdom; United States of America.

Awards linked to the item

The authors thank study patients, their supporters, and investigators and clinical research staff at study centers. Medical writing and editorial assistance were provided, under the direction of the authors, by Maryann Obiorah, PhD, and Miriam Cohen, PhD, ISMPP CMPP of Bio Connections, LLC (Chicago, IL), supported by BeiGene.