BeiGene announces Phase 1b results of zanubrutinib with Gazyva
BeiGene announced results from an ongoing Phase 1b clinical study of its investigational BTK inhibitor zanubrutinib in combination with Gazyva in patients with relapsed/refractory or treatment naive chronic lymphocytic leukemia or small lymphocytic lymphoma, and patients with R/R follicular lymphoma. The open-label, Phase 1b trial of zanubrutinib in combination with obinutuzumab in patients with B-cell malignancies is being conducted in Australia, the United States, and South Korea, and consists of a dose-escalation phase and a dose-expansion phase in disease-specific cohorts, including patients with TN or R/R CLL/SLL and patients with R/R FL. Of the 20 patients with TN CLL/SLL, the overall response rate was 100%; the complete response rate was 30.0%; and the partial response rate was 70.0%. Median follow-up for these patients was 28.8 months. Of the 25 patients with R/R CLL/SLL, the ORR was 92.0%; the CR was 28.0%; and the PR was 64.0%. Median follow-up for these patients was 28.9 months. "These updated data provide further evidence for the rational combination of zanubrutinib and obinutuzumab, and build upon the foundation supporting our global pivotal Phase 2 trial comparing obinutuzumab plus zanubrutinib to obinutuzumab alone as a treatment for patients with R/R follicular lymphoma. It is our hope that we will continue to see deep and durable responses for these patients," said Jane Huang, M.D., Chief Medical Officer, Hematology, at BeiGene.