Treatment of CD79B Mutant Relapsed/Refractory Diffuse Large B-Cell Lymphoma With Bruton Tyrosine Kinase Inhibitor Zanubrutinib

Prior treatment

• Participants had prior exposure to a Bruton's tyrosine kinase inhibitor.
• Participants had received any of the following treatments within the specified timeframe prior to the first dose of study drug:
  • Corticosteroids administered with antineoplastic intent within two weeks prior to study treatment. A short course (seven days or fewer) of systemic corticosteroids at doses of 20 milligrams per day or less of prednisone equivalent for control of lymphoma-related symptoms was permitted prior to enrollment, provided the corticosteroids were tapered off within five days after initiation of study treatment.
  • Chemotherapy or radiotherapy within two weeks.
  • Monoclonal antibody therapy within two weeks.
  • Investigational therapy within two weeks.
  • Chinese patent medicine administered with antineoplastic intent within two weeks.

Other illness

• Participants had a history of allogeneic stem cell transplantation or chimeric antigen receptor T-cell therapy.
• Participants had a history of other active malignancies within two years prior to study entry, with the exception of:
  • Adequately treated carcinoma in situ of the cervix;
  • Localized basal cell carcinoma or squamous cell carcinoma of the skin; or
  • A previous malignancy that was confined and treated locally (by surgery or other modality) with curative intent.
  • Note: Other protocol-defined inclusion and exclusion criteria may have applied.

Other

• Participants had non-Hodgkin lymphoma other than classical histology diffuse large B-cell lymphoma (not otherwise specified), including but not limited to:
  • Diffuse large B-cell lymphoma transformed from indolent lymphomas
  • Primary mediastinal (thymic) large B-cell lymphoma
  • Primary cutaneous diffuse large B-cell lymphoma
  • Primary effusion lymphoma
  • Central nervous system lymphoma

• Participants had histologically confirmed diffuse large B-cell lymphoma, based on the World Health Organization 2008 classification of tumors of hematopoietic and lymphoid tissue.
• Participants had a positive CD79B gene mutation, as confirmed by a central laboratory.
• Participants had previously received at least one line of adequate systemic therapy for diffuse large B-cell lymphoma, defined as anti-CD20 antibody-based chemoimmunotherapy administered for at least two consecutive cycles, unless disease progression occurred before completion of Cycle 2.
• Participants had relapsed or refractory disease prior to study entry, defined as either:
  • Recurrent disease after achieving disease remission, defined as a complete response or partial response, at the completion of the most recent treatment regimen; or
  • Stable disease or progressive disease at the completion of the most recent treatment regimen.
• Participants were ineligible for high-dose therapy and stem cell transplantation, defined as meeting at least one of the following criteria:
  • Presence of significant organ dysfunction, such as:
  • Left ventricular ejection fraction less than 50 percent as measured by echocardiogram or multiple gated acquisition scan;
  • Diffusing capacity of the lung for carbon monoxide less than 60 percent of the predicted value as measured by pulmonary function testing; or
  • Creatinine clearance less than 70 milliliters per minute as demonstrated by nuclear medicine scan or 24-hour urine collection; or comorbid conditions that precluded the use of high-dose therapy and stem cell transplantation due to an unacceptable risk of treatment-related morbidity.
  • Failure to achieve a complete response or partial response following salvage therapy.
  • Failure to collect stem cells or inability to undergo stem cell collection, as assessed by the investigator.