Cancer Conference Update: A Multimedia Review of Key Presentations from the 2016 American Society of Hematology Annual MeetingAbstract 470: Results of the Phase III GOYA study evaluating obinutuzumab or rituximab with CHOP in patients with previously untreated DLBCL
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TRANSCRIPTION:
DR LOVE: So we were talking about obinutuzumab in follicular lymphoma. And there was another paper, the so-called GOYA study, presented with obinutuzumab versus rituximab/chemo in large cell lymphoma. Can you talk about that? DR FLOWERS: Sure. So let me just pull up that abstract. So this was one of the Phase III trials that I alluded to in diffuse large B-cell lymphoma as being one of, unfortunately, several negative trials that we’ve seen trying to improve upon R-CHOP. So when you look at R-CHOP therapy, that has been an approach that has been the standard of care since several randomized controlled trials showed that the benefit of adding rituximab anti-CD20 antibody therapy to CHOP therapy had benefits over CHOP. Since that time, there have been a number of approaches that have tried to improve upon that. The 2 trials looked at the addition of bortezomib to CHOP therapy, to R-CHOP therapy, and showed no clear benefit for patients with the non-GCB subtype and another trial that showed no benefit overall in diffuse large B-cell lymphoma. There is an ongoing trial — or 2 ongoing trials that have completed accrual looking at lenalidomide plus R-CHOP versus R-CHOP that we’re awaiting results on. And then this trial was a trial looking at anti-CD20 antibody, obinutuzumab, with CHOP versus R-CHOP in a very similar fashion to the trial for follicular lymphoma. When you look at the diffuse large B-cell lymphoma trial, however, there really was no clear advantage to adding obinutuzumab to CHOP compared to the R-CHOP therapy. And this trial, they randomized more than 1,400 patients, 706 patients to the G-CHOP arm and 712 patients to the R-CHOP arm. These were trials that were relatively well balanced and fairly typical of the average patient with diffuse large B-cell lymphoma, having a median age of 62 years in this population, and focusing on patients with advanced-stage disease, with more than three quarters of those patients having advanced-stage disease, Stage III/IV disease, in the population. They also looked at the subsets of patients with diffuse large B-cell lymphoma that we commonly divide them into by cell of origin, with a little bit more than half of those patients falling into the GCB arm, as is typically seen with the ABC and GCB components, generally dividing about equally in most large studies where that’s been looked at. When you look at the outcomes of this trial, though, looking at 3-year progression-free survival, there really was no benefit to G-CHOP compared to R-CHOP, so no significant difference in 3-year progression-free survival for obinutuzumab/CHOP versus rituximab/CHOP. I think one of the other interesting things about this trial and about a number of the trials that I mentioned, particularly the trials that have looked at bortezomib plus R-CHOP, is that the R-CHOP control arm of all of those trials have tended to fare better than the historical arms of R-CHOP, either in the older German trials or the older French trials, or the older trials in the US that ultimately led to the demonstration of benefit of R-CHOP. Whether we’re more highly selecting patients to go onto these randomized Phase III trials because R-CHOP is available as the standard of care or there’s some other reason that the R-CHOP is faring better because of supportive care or other measures, I think it’s a little bit unclear. But clearly the standard of care bar is much higher than we’ve been able to achieve with any of these new advances. |