DR BROWN: So it was a Phase IB study and center-selected enrollment for their center. So there were 20 patients per arm. In the bendamustine/obinutuzumab arm, neutropenia was significantly higher than has been previously reported with BR. Around 55% of the patients had Grade 3/4 neutropenia. That being said, the majority got through 6 cycles. Median was 5.7 cycles. And response rate was 90%. And the complete remission or complete remission with incomplete count recovery rate was 45%, with the caveat that there were only 20 patients on the study. Looks promising. There were a couple of early discontinuations for cytopenias.

On the FC/obinutuzumab arm, the described rate of Grade 3/4 neutropenia was 48%, which is not so dissimilar. It’s actually lower than CLL10. More growth factors were used, though. There were several patients who discontinued early in the setting of cytopenias, and it’s unclear if that was related to the regimen or that there might have been an element of patient selection. I think it’s hard to know whether that regimen may induce more cytopenias than a rituximab-based regimen. And I wouldn’t recommend it for general practice use. The efficacy was quite high in terms of clearing bone marrow. The response rate, as reported, looked low at 62% because response rate was based on an intention-to-treat analysis and there were a number of patients not evaluable due to coming off early or not getting the required evaluations.

DR LOVE: Where do you see these combinations heading?

DR BROWN: I think they need to be studied further in order to understand them. The bendamustine/obinutuzumab regimen, while more myelotoxic, is relatively manageable. I’m not sure yet, based on the 20 patients from the FC/obinutuzumab, how manageable that regimen is.

Chronic Lymphocytic Leukemia (CLL)

Chronic Myeloid Leukemia (CML)

Acute Myeloid Leukemia (AML) and Acute Promyelocytic Leukemia (APL)

Myelodysplastic Syndromes (MDS)

Acute Lymphocytic Leukemia (ALL)