Thursday, June 29, 2017

Two Excellent R-Squared Studies for Follicular Lymphoma

It seems to me that the combination treatment that has gotten the most excitement from researchers in the last 5 years has been R-squared -- Rituxan + Revlimid (also known as Lenalidomide). Even when research results seem kind of mediocre to me, researchers comment on how great R-Squared is.

And now there are a couple more reasons for them to be excited. Both came from research that was presented this month at the 2017 International Conference on Malignant Lymphoma in Luagano, Switzerland.

The first study looked at R-Squared in Follicular Lymphoma patients who had not had any previous treatments. Results were excellent, with 95% of the 66 patients getting a response, and 72% of them getting a Complete Response. More importantly, The 5 year Progression Free Survival rate was 70%.

Seems like something that worth getting excited about.

The other study looked at a different population -- FL patients who had been heavily treated, with some of the 160 Follicular Lymphoma patients in the study having already received up to 9 previous treatments.
2017 International Conference on Malignant Lymphoma210

For this study, patients received R-Squared, and were then given maintenance of either straight Rituxan, or more R-Squared.

Results were, again, very strong, especially since this group was either double refractory to immunochemotherapy (both Rituxan and traditional chemo had stopped working), or had "high risk" FL, or had relapsed early (within 2 years after diagnosis and first treatment).

Of the 50 FL patients who were double refractory, the Overall Response was 45%, with a 21% Complete Response rate. The 1 year PFS for this group was 65%.

Of the 52 FL patients who relapsed early, the Overall Response was 47%, also with a 21% Complete Response rate. The 1 year PFS for this group was 49%.

Of the 60 FL patients who were considered High Risk, the Overall Response was 66%, and the 1 year PFS for this group was 70%.

This second study was a phase III clinical trial, which means it could be ready for FDA approval soon.

It is worth noting that, for all the excitement R-Square creates, it has not been approved yet by the FDA for any Follicular Lymphoma patients. there have been concerns about Lenalidomide/Revlimid's toxicity for a while. In this second study, there were several side effects, including several types of low white blood cell counts that could lead to higher risk of infection, fever, and blood clots. 

But overall, these studies seem to add to the happy feelings that lymphoma researchers have about the combination.  Another arrow in the quiver -- perhaps soon.

[Note: I usually give links to the conference abstracts for something like this, but I'm having trouble accessing them, so you're getting links to reports about them instead.]
The 1-year progression-free survival (PFS) rate was 70% with rituximab and lenalidomide. In the double refractory and early relapse groups, the 1-year PFS rates were 65% and 49%, respectively. In the early relapse group, the 1-year PFS was similar in those who received frontline rituximab/chemotherapy (n = 39; 52%) and those received a non-rituximab chemotherapy regimen (n = 13; 44%). In high-risk patients, the 1-year PFS rate was 70%.


The 1-year progression-free survival (PFS) rate was 70% with rituximab and lenalidomide. In the double refractory and early relapse groups, the 1-year PFS rates were 65% and 49%, respectively. In the early relapse group, the 1-year PFS was similar in those who received frontline rituximab/chemotherapy (n = 39; 52%) and those received a non-rituximab chemotherapy regimen (n = 13; 44%). In high-risk patients, the 1-year PFS rate was 70%

3 comments:

Anonymous said...

Personally I missed out on trial in the UK because my healthcare team have a fixation on watch and wait.
The Doctor said that drug has horrible side effects, it’s a cousin of thalidomide.
The trial filled up very quick.
I think the drug is around 26k a shot in the UK.
I just recently finished a trial between Rituximab and a bio similar 4 doses over 4 weeks.
I will not know what I got, but I am now in remission.
The scan in November will tell me how good it is.
But my symptoms have gone plus others that I didn’t know for sure were symptoms but guessed they might be.

Lymphomaniac said...

Congratulations on the remission. Sounds like you were placed in a pretty good trial anyway. Good luck with the scan in November -- give us an update.
Bob

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