Full R-Squared Results

Earlier this month, I wrote that the R-Squared combination is going to get Priority Review from the FDA for Follicular Lymphoma patients who have already received a treatment.

R-Squared is the popular name for the combination of Rituxan and Revlimid (also known as Lenalidomide).

The Priority Review decision was based on results from the phase III AUGMENT trial. The full write up of those results is now available from the Journal of Clinical Oncology. The article is called "AUGMENT: A Phase III Study of Lenalidomide Plus Rituximab Versus Placebo Plus Rituximab in Relapsed or Refractory Indolent Lymphoma."

The study involved 358 patients from several different countries. They all had either FL or Marginal Zone Lymphoma, another slow-growing, incurable lymphoma. All had already received at least one treatment (chemo, immunochemo, or immunotherapy, and two or more doses of Rituxan, and all had their lymphoma come back after treatment.

The patients were divided into two groups. 178 of them received R-Squared, and 180 received Rituxan plus a placebo. (This kind of direct comparison is important, and the best way to really test a new treatment against an already-established treatment. It allows the researchers to control the comparison, rather than comparing results with a study that happened 5 years before with patients that they didn't choose themselves.)

The endpoint for the study was Progression Free Survival -- essentially measuring how long it took for the disease to come back (or for the patient to die). The median PFS for the R-Squared group was 39.4 months (half of patients had an event before that, and half after that, or didn't have an event at all). For the Rituxan group, the PFS was 14.1 months. R-Squared was clearly superior.

While PFS was the main way of measuring the two treatments, there were some other endpoints for the study, and R-Squared was superior in all of them, too. Overall Survival results are "Still maturing," according to the researchers, which is good -- there haven't been enough deaths to say what the halfway point is.

As for safety, there were, of course, side effects. The R-Squared group had more patients with more serious side effects than the Rituxan group. These were already known, and seem typical (lower blood counts, nerve issues, digestive issues). there were two deaths in each group during the trial.

The conclusion to this study: R-Squared will provide another effective alternative for Follicular lymphoma patients who have had previous treatment.

As I said in my earlier post about the FDA review decision, I've been reading about R-Squared for a very long time (almost 10 years), and it's great to see the results of all the excitement that researchers have had about it for all that time.

The approval from the FDA will come sometime in the fall. Seems like chances are good for another arrow in the quiver.