In a nutshell
This study aimed to investigate the combination of zanubrutinib (Brukinsa) and obinutuzumab (Gazyva) in patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) and follicular lymphoma (FL). This study concluded that this combination was well tolerated and had promising responses in these patients.
Zanubrutinib is a new generation tyrosine kinase inhibitor (TKI). It is more selective and has fewer off-target effects. TKIs are a type of targeted therapy used for the treatment of leukemia/lymphoma. Obinutuzumab is an immunotherapy drug used in combination with chemotherapy for the treatment of CLL/SLL and FL.
It was unknown if a combination of zanubrutinib and obinutuzumab would be safe and effective in patients with CLL/SLL or FL.
Methods & findings
This study involved 81 patients with CLL/SLL (45) and relapsed/refractory FL (36). All patients received obinutuzumab and zanubrutinib. Patients were followed up for an average of 29 months (CLL/SLL) and 20 months (FL).
Zanubrutinib was tolerable at 160mg twice daily or 320mg once daily combined with obinutuzumab. The overall response rate (ORR) was 100% in previously untreated patients with CLL/SLL and 92% in patients with relapsed CLL/SLL. The ORR was 72% in patients with relapsed/refractory FL.
Common side effects included upper respiratory tract infection, low white blood cell counts, bruising, cough, and tiredness. The most common severe side effect was low white blood cell count (31% of the CLL/SLL group and 14% of the FL group).
Five patients needed temporary dose reductions and 5 patients stopped treatment due to side effects.
The bottom line
This study concluded that the combination of zanubrutinib and obinutuzumab was generally well tolerated and showed promising responses in patients with CLL/SLL and relapsed/refractory FL.
The fine print
This was a small phase Ib clinical trial. Further, larger trials are needed. This trial was supported by BeiGene, the manufacturer of zanubrutinib.
Published By :
Oct 13, 2020
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