The FDA announced on Friday that it had approved an Obinutuzumab combination for untreated Follicular Lymphoma.
Specifically, the approval is for Obinutuzumab plus chemotherapy (CHOP, CVP, or Bendamustine), followed by Obinutuzumab Maintenance. A similar combination with maintenance was already approved for FL patients who could no longer take a Rituxan-based treatment.
The approval came because of results from the GALLIUM trial, which compared the Obinutuzumab + chemo + maintenance to Rituxan + chemo + maintenance. In the trial, Obinutuzumab showed better Progression Free Survival than Rituxan. Overall Response rate was slightly better as well.
Given the results, it seems appropriate that Obinutuzumab gained FDA approval. The numbers do show that, in the circumstances tested, Obinutuzumab outperformed Rituxan. It's another option for us.
At the same time, though, when the results of the trial were published about a month ago, some experts questioned whether or not Obinutuzumab really was superior. The doses of the two treatments weren't same (Obinutuzumab's was higher), and the adverse events (bad side effects) were higher for Obinutuzumab as well. Lots of experts thought this meant there was not as clear a reason to switch from Obinutuzumab to Rituxan as it might seem at first.
But the approval is there now. Time will tell if oncologists make the switch.
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Updated results from the GALLIUM trial will be presented at ASH next month.
It looks like there are several presentations about data from the GALLIUM trial.
One that really stands out to me is called "Early Disease Progression Predicts Poorer Survival in Patients with Follicular Lymphoma (FL) in the GALLIUM Study."As part of the analysis of the GALLIUM data, researchers looked at POD24 -- patients who had Progression of Disease within 24 months after receiving immunochemotherapy (which would include patients in both the Obinutuzumab and Rituxan arms of the GALLIUM trial). It's been known for a few years now that this particular group of patients (about 20% of those with FL) has a lower Overall Survival that other Follicular Lymphoma patients.
The researchers found that the Obinutuzumab patients had a better chance of not being in the POD24 group (about a 33% better chance). However, overall, the study confirmed the idea that POD24 was an issue -- patients who have had immunochemotherapy whose disease returns or gets worse within 24 months have a lower Overall Survival rate.
While the whole idea of POD24 concerned FL experts, it also gave them some hope. Identifying this group of patients meant that they could start working on identifying them early and finding treatments that would be effective.
I'm working my way through those abstracts and trying to find a way to make sense of them all.
If you're in that group, stay hopeful -- a greater chance of something doesn't mean it's guaranteed. And some of the ASH research of POD24 seems to provide more reasons to be hopeful. That problem isn't solved, but it's clear that there are a lot of smart people who are looking into it.
More ASH stuff soon.
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9 comments:
Hi, Bob.
24 months after the diagnosys or after the mantence?
Thanks.
Rodrigo
Brazil
Bob,
What are your feelings about maintenance? It seems there are many pros and cons even with Rituxan maintenance. I just finished 6 cycles of Bendamustine and Rituxan and have decided to forgo maintenance at this point, even though my largest node is still at 3.2cm (originally at 7.7cm). Advice?
Thanks,
Teri
Rodrigo,
Typically, in a study involving treatments, like this one, they will measure time from the date of the first treatment. That would make sense in this case.
Other studies have different goals and different time measurements. If it was a study about how long people watch and wait, for example, they would probably measure starting at diagnosis.
Bob
Hi Teri.
I have mixed feelings about maintenance, because the research is so mixed. The latest I have seen is that it seems to work best with patients who had a Complete Response to Immunochemotherapy (like B + R). But "the latest" isn't "the best" with something like maintenance, because it seems like the research goes back and forth about its value. So I can't really give you a good answer. If you wanted to forgo maintenance and your onc didn't insist that you do it, I guess that's a good sign that it was a good choice for you. I'm sure you're staying vigilant and working with your onc about what your next steps would be in different scenarios.
[And since you asked for "advice," I'm going to remind you and everyone that I'm not an oncologist, and not a cancer researcher, so any "advice" I give is just my own un-expert thoughts. Your oncologist is the best person to seek advice from.]
Good luck, Teri. Keep us updated.
Bob
Thanks, Bob.
But my question is: Is rituximab maintenance considered "treatment" or just the R-CHOP, in my case?.
For example, I finished R-CHOP in august 2012, being in complete remission since then. But I had 2 years of rituximab maintenance, and finished it in november 2014.
When I start the counting? In august 2012 or november 2014?
Thanks again!
Rodrigo
Rodrigo, for the POD24, you would start counting on the date of your first treatment -- August 2012.
Thanks for the "advice" Bob...I really appreciate and respect your "un-expert" thoughts! I, too, feel the research is very mixed on this issue and when I started to express my concern with my oncologist, he basically said "I am not here to twist your arm on having maintenance"...so he didn't "insist" but I think it is just a "standard" practice with them. He reminds me a little of your Dr. K...
Thanks again!!
Teri
Teri and Bob: I too recently completed six cycles of BR - finishing in Sept 2017. I have opted for the R Mtnc (planned every 8 weeks for 2 years). It is a tough decision. I was swayed by the fact my mother who also had FL (at age 90) had undergone Rituxan mono therapy followed by Mtnc and done very well and also I believe the Canadian guidelines recommend maintenance. My onc left the decision to me - she indicated she wouldn't have strongly recommended it for me (age 58) as someone relatively young who may have subsequent treatment courses down the road, but would recommend it for older patients to hopefully defer any subsequent treatments.
So, whatever route you're most comfortable with is most likely the best choice. If we're looking for certainty in treatment regimens and outcomes I guess that went out the door at the time of our diagnosis!
Hi Bob,
After 6 rounds of RCHOP in 2013, my Onc. recommended 2 year R-Maintenance. We discussed how some studies showed a longer remission period but that there were mixed results. In the end, we decided to do it and I'm glad I did. In my case, I was stage 4 at diagnosis with severe B symptoms, bone marrow and blood involvement . The disease and chemo were so tough on my body, that if there is a chance that I can have a few extra years in remission, I'll take it. I realize that some people experience side affects during R Maintenance, but for me it was a piece of cake, especially compared to the chemo.
It truly is a personal decision, as long as the decision is an informed one.
Lilly
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