BeiGene, Ltd. said its investigational drug zanubrutinib was effective in separate trials in patients with certain types of blood cancer.
Mantle cell lymphoma
The company said a phase 2 trial evaluating zanubrutinib in 86 Chinese patients with mantle cell lymphoma, a rare and aggressive form of non-Hodgkin lymphoma, whose cancer had returned or who did not respond to treatment showed that the drug reduced the cancer in 84% of the patients.
In addition, 59% of the patients on zanubrutinib, an inhibitor of the Bruton's Tyrosine Kinase, or BTK, protein saw no detectable cancer after treatment.
BeiGene plans to submit an application for approval of zanubrutinib in China later this year to treat this patient population.
A phase 1 trial of zanubrutinib as a single therapy in 51 evaluable patients with Waldenström macroglobulinemia showed that 47 patients saw a reduction in their cancer. At 12 months, 91% of the patients had lived without their disease worsening.
Waldenström macroglobulinemia is a type of non-Hodgkin lymphoma in which cancer cells make large amounts of an abnormal protein called a macroglobulin.
The company is conducting a phase 3 study comparing zanubrutinib to Johnson & Johnson's Imbruvica in patients with the disease and plans to submit an application in the U.S. in 2019 for approval of the drug to treat this patient population.
In addition, BeiGene said pooled analysis from four ongoing trials of zanubrutinib as a stand-alone therapy for treating certain B-cell lymphomas showed that the drug was well-tolerated and can achieve complete and sustained BTK inhibition.