V1,
This Bex+Flu data is indeed tremendous - congrats to you for (another) great call, made some time ago, that we should focus on these results, that they had the potential to be very significant. Indeed, it appears that the Bex "home run" scenario is in full swing - great data for first-line use, now with little or no HAMA (suppressed by the Fludara).
When these ASH abstracts were first published online, I got concerned that the complete response rate shown in the abstract was about 43%, inferior to reported CR rates for first-line Rit+CHOP (now reported as 63% by IDEC), and I privately passed along these concerns to a few folks as something to watch.
Well, as you mentioned here a few days ago, it was important to wait for updated results here at the conference, because the 43% CR reported in the abstract (three month followup) has become 71% CR at six-month followup. So I got antsy a little too early, should have remembered that Bex responses sometimes take many months to complete. Had a nice conversation at the poster session with study author Dr. Leonard, he mentioned that they have seen Bex patients who take as long as a year to reach their best response level - which to me hints that we might even see a few more complete responses roll in over the next 3-6 months that goose the 71% CR number a little higher.
Of course, this is an early, relatively small study, but the 71% CR beats the 63% CR reported for Rit+CHOP - I would say that round one for efficacy goes to Bex+Flu at this point. Also of course, they have longer followup data for Rit+CHOP and excellent numbers for progression-free survival after three-year followup, will be quite some time until we have Bex+Flu numbers of this sort that we can use for comparison. But Bex+Flu efficacy sure looks good based on what data we do have for both regimens at this time.
When you flip the coin to compare side effects, I am starting to believe that we will find Bex+Flu to be superior to Rit+CHOP in term of safety profile as well, especially in light of some discussions I've had today - more on that later (gotta get some shuteye now!)...
Well, I asked lotsa questions today, but didn't think to ask Dr. Leonard if they had done any PCR confirmation in this study. Drat! I've reviewed a printed copy of the poster that I brought back from the session, and there's no mention one way or the other. I'll hit the Coulter/SmithKline booth tomorrow and see if someone knows...
Cheers,
Gordon |
