News Feature | December 10, 2014

Roche To Present Data For Gazyvaro And MabThera At ASH 2014

By Estel Grace Masangkay

Roche announced that it will present new data for two of its approved hematology drugs Gazyvaro (obinutuzumab) and MabThera/Rituxan (rituximab), along with other medicines at the 56th American Society of Hematology (ASH) Annual Meeting in San Francisco.

Gazyvaro is a novel monoclonal antibody (mAb) that targets and binds the B cell protein CD20 to help the body’s immune system fight cancer cells. The drug is currently undergoing review in the EU and received a positive recommendation from the CHMP as treatment for CLL earlier this year. MabThera is also an anti-CD20 drug indicated for the treatment of non-Hodgkin lymphoma. MabThera received approval for the indication in the EU in April.

Roche will present data from the maintenance phase of the early-stage study GAUDI investigating Gazyvaro in combination with chemotherapy or bendamustine in follicular lymphoma. Preliminary results from the Phase 3B study GREEN of Gazyvaro as monotherapy or in combination with chemotherapy for treatment-naïve r/r CLL will also be included. The company will present findings for MabThera subcutaneous in treatment-naïve CLL in addition to updated data of the drug in CLL.

Aside from the company’s anti-CD20 drugs, findings from several other studies will be presented at the meeting, including those for investigational BCL-2 inhibitor venetoclax across a range of blood cancers. Data for the investigational MDM2 antagonist RG7388 and updated information on the anti-CD79b antibody drug conjugate polatuzumab vedotin will also be presented. Finally, results from the Phase 1B study of investigational bispecific antibody ACE910 in hemophilia A will also be presented at the meeting.

Sandra Horning, Roche’s CMO and head of global product development, said, “We are excited about our contribution to ASH this year because we are presenting data across a range of diseases and treatment settings, including combinations with Gazyva in a variety of blood cancers.”

In October, Roche announced that it has entered into partnership with Pharmacyclics to conduct a late-stage study of Gazyvaro and Imbruvica as a combination cancer therapy.