ASH Preview: R-Squared

Next up in previewing some of the research that I find interesting at ASH: some stuff about R-Squared.

R-Squared, if you're new to this, is the combination of Revlimid (also known as Lenalidomide) and Rituxan. A few months ago, the FDA approved R-Squared for some patients with previously-treated Follicular Lymphoma. And just yesterday, the Committee for Medicinal Products for Human Use recommended that the European Commission approve R-Squared for the same group of patients. That decision should come in about two months.

R-Squared is a big deal because it's the first combination approved for FL that does not involve some kind of traditional chemotherapy. Chemo can be very effective on FL, but with some side effects that can also damage a lot of healthy cells in the process. R-Squared is more targeted -- it spares healthy cells more than chemo does, but it also has a different bunch of side effects, sometimes also severe.

It's one of those treatments that oncologists get very excited about. It shows that there is promise for Follicular Lymphoma treatments that are not chemo.

There's still a lot of R-Squared research going on, particularly for patients with FL who have not yet received treatment. A fairly safe, effective, non-chemo treatment for first treatment would be another great option.

Two of the ASH presentations that I found interesting looked at just this issue.

The first is called "A Phase II Study of Lenalidomide Plus Rituximab in Patients with Newly Diagnosed Follicular Lymphoma: An Interim Analysis." This presentation is an "interim analysis" -- the phase II study isn't finished yet, but they're giving us some results. The researchers are from China, as are the patients. So far there have been 86 patients in the trial. Interestingly, the median age of the patients is 48, and the range of ages is 22 to 73. It's a fairly young group, compared to the typical age for someone diagnosed with FL, which is about 65. The results have been good so far, with 64 patients being evaluated. There is an Overall Response Rate of 90% (58 of 64), and a Complete Response rate of 81% (52 of 64). The side effects are manageable, and seem in line with the side effects in the previously-treated FL group.

A second interesting presentation on FL and R-Squared is "Predictive Factors of Response and Survival of Lenalidomide and Rituximab As Initial Treatment of Follicular Lymphoma." This study looked back at 98 FL patients who had been given R-Squared as a first treatment. Response rates were similarly great -- 98% Overall Response Rate, and a 90% Complete Response Rate, after 6 months. After 88 months (a little more than 7 years), 31 patients progressed or died. Only 3 patients had transformed disease, and 2 patients died (one from disease progressing, and one fro unrelated health issues).

The news looks good for R-Squared as a possible first treatment. There is a growing body of evidence (including these two reports) that shows good effectiveness with manageable side effects.

The weeks following a big conference like ASH often have announcements of FDA applications. The research gets presented at the conference, and pretty soon, the process starts for getting the treatment its official approval.

I don't now if that's the plan right now (the first one I looked at above is a study from China, and the second looks back at patients, rather than showing trial results), but my guess is the approval will be sought by someone soon.