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ASCO 2022: Zanubrutinib Plus Obinutuzumab Versus Obinutuzumab Monotherapy in Follicular Lymphoma

By: Vanessa A. Carter, BS
Posted: Friday, June 24, 2022

Pier Luigi Zinzani, MD, of the Institute of Hematology “Seràgnoli,” University of Bologna, Italy, and colleagues conducted the phase II randomized ROSEWOOD trial to assess the safety and efficacy of the Bruton’s tyrosine kinase (BTK) inhibitor zanubrutinib plus the monoclonal antibody obinutuzumab versus obinutuzumab monotherapy in patients with relapsed or refractory follicular lymphoma. It was concluded that the combination therapy demonstrated superior efficacy to the monotherapy in this population, and these results were presented during the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract 7510).

The investigators focused on 217 patients with relapsed or refractory follicular lymphoma who received two or more prior lines of therapy that included an alkylating agent and an anti-CD20 antibody. Participants were randomly assigned 2:1 to receive either zanubrutinib plus obinutuzumab (n = 145) or obinutuzumab alone (n = 72) until 20 doses, progressive disease, or unacceptable toxicity. Individuals with progressive disease on monotherapy were allowed to cross over to combination therapy.

The median follow-up was 12.5 months, and patients received a median of three prior lines of therapy; 28% given zanubrutinib plus obinutuzumab and 25% given obinutuzumab alone had received more than three prior lines of therapy. The objective response, complete response, and 18-month duration of response rates among patients on combination therapy and monotherapy were 68.3% versus 45.8%, 37.2% versus 19.4%, and 70.9% versus 54.6%, respectively.

The median progression-free survival among individuals treated with zanubrutinib plus obinutuzumab was 27.4 months, which was higher than the 11.2-month median survival of those treated with obinutuzumab alone (P = .004). For patients who crossed over to combination therapy, the objective response rate was 24.1%. Additionally, the 18-month overall survival probability was 85.4% and 72.6% with the combination therapy and the monotherapy, respectively. The most common adverse events of any grade were thrombocytopenia and neutropenia, and the incidence of treatment-emergent adverse events leading to death was slightly higher among those given obinutuzumab (9.9%) than for patients given zanubrutinib plus obinutuzumab (5.6%).

Disclosure: For full disclosures of the study authors, visit coi.asco.org.


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