The Phase III GADOLIN Trial

Transcript:

Ian Flinn, MD: We’re also seeing updated data here, Pier Luigi, of the GADOLIN trial, Dr Laurie Sehn’s presentation of obinutuzumab-bendamustine.

Pier Luigi Zinzani, MD, PhD: Yeah, the data are really impressive. There was an update after 4 years on more than 400 patients. At the end of the day the time to the next treatment, the median time to next treatment comparing the standard of obinutuzumab as a single agent versus the study arm—obinutuzumab plus bendamustine—and then consolidation with obinutuzumab is really different. An advantage of the study arm is 3 months versus 18 months. So it’s really impressive. But at the end of the day, as we discussed also before, it depends on the frontline treatment of our patients, because, for example, in Europe, as I said before, most European countries are using bendamustine continuously in frontline, so it’s quite impossible to use this as a second-line, third-line treatment including bendamustine again.

Ian Flinn, MD: John, we have the same issue in the United States, right? Most people are using bendamustine-containing regimen. So how do the results of this study figure into your decision making about the long term, the sequencing of patients, your thoughts on that?

John Leonard, MD: Yeah, I don’t tend to retreat patients with bendamustine. It can be done, and there are probably occasional times I’ve done it. But in general I start to worry about the marrow toxicity and the cumulative cytopenias, etc. You know the idea of giving 6 cycles and then another 6 cycles later seems unlikely. Maybe I’ll give another 2 at some point, but it’s really more of a bridge to something else.

That said, I think the GADOLIN study informs me to use obinutuzumab a little more in the relapse setting than in the up-front setting. As I said earlier, I don’t tend to use it as part of my initial treatment, but I tend to use it particularly in a relatively refractory patient as part of their later-line therapy rather than rituximab.

Ian Flinn, MD: If you’re not using it, I worry about the tumor with the toxicity of bendamustine. But if you’re not using it with bendamustine, are you adding it to CHOP [cyclophosphamide, hydroxydaunorubicin hydrochloride, vincristine, prednisone]? What do you do?

John Leonard, MD: I would do that. I think that that’s a reasonable thing to do. Again, it’s an extrapolation, but you have data from the GALLIUM study saying that is a reasonable thing to do.

We’re also looking as part of the intergroup study that’s looking at the early progressor, follicular lymphoma patients. It’s a randomized SWOG-led study looking at early progressing follicular lymphoma, and basically it’s a randomized phase II. It’s a PI3 kinase inhibitor plus obinutuzumab-lenalidomide or obinutuzumab or a chemotherapy, either CHOP [cyclophosphamide, hydroxydaunorubicin hydrochloride, vincristine, prednisone] or BENDA [bendamustine], depending on what the patient had before with obinutuzumab. I think that decision was made for similar reasons.

Ian Flinn, MD: Building on what John was saying earlier about lenalidomide in combination with whatever antibody you’re using—if you’re using rituximab up front, if you were to use a combination—maybe it would pan out that using obinutuzumab with lenalidomide might make sense in that setting.

John Leonard, MD: Certainly in more resistant patients, definitely.

Ian Flinn, MD: Yeah. I guess we’ll have to wait really and truly for the data to come out to make the firm statements there.

Transcript Edited for Clarity