Tuesday, September 1, 2015

R-Squared: Phase II Trial Success

I've seen reports and articles on a bunch of Follicular Lymphoma research in the past couple of weeks, and I'm very slowly getting around to reading it.

Up first: results from a phase two trial of Rituxan and Lenolidomide (also know as Revlimid, making this combination R + R, or R-squared).

The combo has been around for a few years, and there has been some excitement in the lymphoma community about it, based on early results from the trial. The Journal of Clinical Oncology spells out the details in "Randomized Trial of Lenalidomide Alone Versus Lenalidomide Plus Rituximab in Patients With Recurrent Follicular Lymphoma: CALGB 50401 (Alliance)."

(Before I get to those details, check out the link and look at the Lymphoma Rock Stars in the authors' list, including John Leonard, Myron Czuczman, and Bruce Cheson. Damn. You know you're a Cancer Nerd when you see the authors list on a medical journal article and you squeal like a 14 year old girl who has seen that 5 Seconds of Summer, One Direction, and Fall Out Boy are performing live on the Grammy Awards telecast. And I say that as the father of a music-loving 14 year old girl.....)

Anyway, as the article explains, the trial compared Revlimid/Lenolidomide on its own with Revlimid combined with Rituxan (the R-Squared). The trial involved 91 patients, roughly half of them receiving each of the treatments. Revlimid/Lenolidomide on its own resulted in a 53% Overall Response Rate (20% Complete Response), while the R-Squared combo had a 76% Overall Response Rate, with 39% achieving a Complete Response.

The Conclusion to the phase II trial is that the R-Squared combination was successful enough to justify a phase III trial, with a larger number of patients.

These results were first reported in 2012, and have finally been reviewed by other experts to show that the results are as good as they seem. This is one of a bunch of studies on Revlimid and R-Squared that are going on now (here's another one). We won't see results from the phase III trial for a while, but we've seen enough people with positive results to call this an unofficial success.

Looking forward to it being official.

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