Give us an overview of the FCR study results you presented at iwCLL 2013 in the late-breaking session

The FCR regimen was developed at MD Anderson by Michael Keating and we initiated a clinical trial back in 1999.

So the first patient was treated on this trial in July of 1999 and over the subsequent several years, five years, we accrued about 300 patients into the first FCR trial.

It was the encouraging results that Michael reported for that trial early that led the German CLL study group to study it in a randomised trial.

The original FCR trial enrolled 300 patients and we followed those patients for a number of years.

The talk that I gave in the late breaking session was the long-term follow-up for those patients treated in the original FCR 300 trial.

Then Kirsten Fischer gave an update of the results of the CLL8 trial which is the randomised trial done by the German CLL study group comparing outcomes of patients treated in the front line setting with FCR versus FC.

That trial, as you probably know, showed a survival advantage for the chemo-immunotherapy regimen over the FC regimen.

The highlight for that session and the features for both of the studies that have created some discussion and that is the most important aspect of this update is that in our long-term follow-up from our original FCR experience where we have about 11½ years as our median follow-up we see a plateau on the progression free survival curve where we have long-term non-progressing patients.

Unfortunately we don’t have all the prognostic factors evaluated for the patients who went on that study because it was before some of them were reported but we’ve gone back retrospectively and evaluated things like IgVH mutation status and we’re working on doing retrospective testing for FISH.

But in terms of identifying groups that do exceptionally well treated with FCR we have identified that patients who have a mutated V gene, approximately 60% of them are progression free at nine year follow-up.

After the nine year follow-up the curve for progression free survival flattens out.

So that leads to the question about whether or not we’re appreciating a cure fraction with this treatment in a subgroup of patients treated with FCR.

The additional excitement came from a very similar observation in terms of long-term progression free survivors in the mutated group that the German CLL study group trial on the FCR arm has shown and is what Kirsten Fischer reported at this meeting at the late breaking session.