DR SEHN: So the trial was designed to evaluate the addition of obinutuzumab to patients who were known to be rituximab refractory, primarily with indolent lymphoma although focused on follicular lymphoma, which was the majority of patients enrolled in the trial. So patients, by definition, had to have had a prior rituximab-containing regimen and had to either not respond to it or relapse within 6 months of receiving it.

They were then randomized to either the bendamustine alone or the combination of bendamustine/obinutuzumab. And for nonprogressers, they went on to get 2 years of obinutuzumab maintenance. So that trial basically revealed that the patients who received the combination treatment actually had a marked improvement in terms of their progression-free survival, so virtually a doubling of progression-free survival that increased from approximately 15 months to about 30 months.

At the initial time of evaluation, which was still fairly early, because this trial actually was stopped at an interim analysis based on that profound improvement, at the initial snapshot there was no difference in overall survival, although there had been a trend for improving overall survival for the obinutuzumab and bendamustine arm. But this trial — updated at the ASH meeting. And I think there’s some very interesting data demonstrating even survival advantage.

DR LOVE: And there’s a press release that’s out there talking about a big trial looking also at obinutuzumab in the up-front setting. What do you know about that at this point?

DR SEHN: So based on the efficacy of obinutuzumab that’s been shown in CLL, as you mentioned, and also in the GADOLIN trial, it seemed logical to move that up front and to test it against rituximab head to head in the up-front setting. So that trial you’re referring to is called the GALLIUM trial.

We haven’t seen the full data of that trial yet, but it has, as you mentioned, been at least hinted in the press release that the trial was found to be positive. So this was a direct comparison of rituximab and chemotherapy versus obinutuzumab and chemotherapy in the up-front setting. And based on what we know, the trial met its endpoint, which was an improved progression-free survival with the obinutuzumab and chemotherapy. So we look forward to seeing the results of that trial, but it’s quite possible that, based on these results, we might find a shift in the up-front standard of care shortly.

Non-Hodgkin lymphoma (NHL), Hodgkin lymphoma and chronic lymphocytic leukemia (CLL)

Acute and chronic leukemias and myeloproliferative neoplasms

Multiple myeloma (MM)