Dr. Danilov on the Safety Profile of Entospletinib Plus Obinutuzumab in CLL

Alexey V. Danilov, MD, PhD, associate director, Toni Stephenson Lymphoma Center, professor, Division of Lymphoma, Department of Hematology and Hematopoietic Cell Transplantation, City of Hope, discusses the safety profile of entospletinib plus obinutuzumab (Gazyva) in chronic lymphocytic leukemia (CLL).

The final results of a phase 1/2 trial (NCT03010358) evaluating entospletinib, an investigational SYK inhibitor, in combination with obinutuzumab demonstrated an overall response rate of 67% in patients with relapsed/refractory CLL.

Regarding safety, entospletinib was generally well tolerated. Of 23 patients treated, one patient developed recurrent aspartate aminotransferase (AST) and alanine aminotransferase (ALT) abnormalities and required treatment discontinuation. Although it is not fully understood why these abnormalities occur, they are commonly observed with SYK inhibitors, Danilov explains.

Expected toxicities of obinutuzumab, such as transient cytopenias and infusion-related reactions, were observed. Ultimately, the combination demonstrated an acceptable safety profile, Danilov concludes.