Gazyva obinutuzumab: Phase Ib data

Data from 19 evaluable patients with relapsed or refractory follicular B cell lymphoma in the Phase Ib portion of the open-label, European Phase Ib/II GALEN trial showed that IV obinutuzumab plus Revlimid lenalidomide led to 7 complete responses, 3 unconfirmed complete responses and 3 partial responses. The combination was well tolerated with neutropenia, constipation, asthenia, upper respiratory tract infection, rash/cutaneous eruption, cough, diarrhea and fever reported as the most common adverse events. The maximum tolerated dose (MTD) was not reached and the recommended dose of Revlimid was 20 mg. Patients received 1,000 mg IV obinutuzumab on days 8, 15, and 22 of the first 28-day cycle and on day 1 of cycles 2-6 in combination with once-daily 10, 15, 20 or 25 mg oral Revlimid on days 1-21 of the first cycle and on days 2-22 of cycles 2-6. Data were presented at the American Society of Hematology meeting in San Francisco. The Phase II portion of the trial is evaluating the combination in patients with relapsed/refractory follicular lymphoma and relapsed/refractory diffuse large B cell lymphoma (DLBCL) and mantle cell lymphoma (MCL). ...