Open, randomized, multicenter phase III study to compare the efficacy of the combination of zanubrutinib (BGB-3111) and anti-CD20 antibodies versus the combination of lenalidomide and rituximab in patients with relapsed/refractory follicular lymphoma or marginal zone lymphoma

Résumé de l'étude

The purpose of this study is to determine whether the experimental drug called zanubrutinib (also known as BGB-3111 or Brukinsa®), when administered with obinutuzumab to treat follicular lymphoma (FL), or with rituximab to treat marginal zone lymphoma (MZL), can help control the disease and prolong the duration of complete or partial remission compared to a commonly used treatment combination: lenalidomide + rituximab. The study will compare not only efficacy but also safety, tolerability, and quality of life between the experimental treatment and the standard treatment. Several countries or regions have approved zanubrutinib for the treatment, in adults, of different types of cancers affecting lymphocytes. In this study, zanubrutinib is still considered an experimental drug because it has not yet been approved by regulatory agencies to treat FL or MZL in combination with obinutuzumab or rituximab. The objective of this study is to compare the efficacy of the combination ZO, zanubrutinib + obinutuzumab, with that of the combination R2, lenalidomide + rituximab, in patients with relapsed/refractory FL (R/R) and to compare the efficacy of the combination ZR, zanubrutinib + rituximab, with that of the combination R2 in patients with R/R MZL.

(BASEC)

Intervention étudiée

Follicular lymphoma (FL) is a blood cancer (non-Hodgkin lymphoma) that occurs when white blood cells (called lymphocytes, cells that circulate in the body to help it fight infections) proliferate excessively. This disease is called follicular lymphoma because abnormal B lymphocytes usually appear in small clusters, the follicles, located within the lymph nodes. The diseased blood cells can circulate and reach many parts of the body, such as organs, bone marrow, and lymph nodes (pea-sized glands located in the neck, groin, and armpits; they are part of the immune system).

Marginal zone lymphoma (MZL) is also a blood cancer (non-Hodgkin lymphoma) that occurs when white blood cells proliferate excessively. There are three types of marginal zone lymphomas: the mucosa-associated lymphoid tissue (MALT) lymphoma, which develops in lymphoid tissue outside the lymph nodes; the nodal marginal zone lymphoma, which develops in the lymph nodes; the splenic marginal zone lymphoma, which develops in the spleen.

Follicular lymphoma and marginal zone lymphoma generally have a slow course but can be more aggressive in some individuals. It can occur at any age but is more common after age 60. Treatment usually yields satisfactory results, but at some point, the lymphoma reappears and must be treated again to remain under control.

(BASEC)

Maladie en cours d'investigation

Patients must have a diagnosis assessed by the investigator of recurrent/refractory indolent lymphoma, defined in this study as Follicular Lymphoma (grade 1, 2, or 3a) or Marginal Zone Lymphoma (MALT type, Mucosae Associated Lymphoid Tissue, nodal, or splenic), must have been previously treated with at least one line of systemic treatment including an anti-CD20 monoclonal antibody (≥ 4 consecutive doses in monotherapy or ≥ 2 consecutive doses in combination therapy), present documented failure to achieve at least a partial response during the most recent systemic treatment or documented progression after the most recent systemic treatment, require treatment, and their bone marrow, liver, and kidney functions must be adequate.

(BASEC)

Sponsor

BeiGene Switzerland GmbH (Note: Company plans to change its name to BeOne Medicines Ltd.) Aeschengraben 27 CH-4051 Basel, Switzerland

(BASEC)