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Positive Results from Previous Phases

Phase 1 and 2 studies have shown that either alone, or in combination with an anti-CD20 monoclonal antibody, Zanubrutinib is generally well tolerated.

 

Zanubrutinib for R / R MZL
Based on efficacy results from two single-arm clinical studies, both of which used the objective response rate (ORR) as evaluated by the Independent Review Committee (IRC) as the primary end point, Zanubrutinib received accelerated approval from the FDA for the treatment of adult patients with R / R MZL who had received at least one anti-CD20-based regimen. The IRC-assessed ORR for those with MZL in Phase 2 of the clinical study was 68.2 percent, with responses observed in all MZL subtypes. 

The ORR and CR for the subtypes were:

Extranodal

ORR, 64 percent;
CR, 40 percent

Nodal

ORR, 76 percent;
CR, 20 percent

Splenic

ORR, 66.7 percent;
CR, 8.3 percent

Unknown Subtypes

ORR, 50 percent;
CR, 25 percent

Zanubrutinib and Obinutuzumab for R/R FL

A combination of Zanubrutinib and Obinutuzumab (ZO) was recently evaluated in a Phase 2 study of patients with R/R FL. In this study, ZO demonstrated superior efficacy to Obinutuzumab alone, had a favorable benefit-risk profile and represented a potential combination therapy for patients with R/R FL. 

The ORR among FL patients treated with ZO was 68.3 percent compared to 45.8 percent with Obinutuzumab alone, and the complete response (CR) rate for ZO was 37.2 percent compared to 18.2 for Obinutuzumab alone. After a median follow-up of 33.9 months, median PFS was 10.4 months.

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MED-US-BGB-3111-2400010