Real Live Time at ASH 2012

I am posting this from the lecture hall at ASH with Jan Burger from MDACC speaking on ibrutinib and rituximab.

Forgive typos and possible errors. This is unedited and I may have made mistakes, so it is not gospel.

Here it is as it happens:

Study was in high risk CLL either 17 p or 11q del or < 3 yr response to FCR

Prior trial of ibrutinib alone good responses including the high risk patients, so more research.

This trial added R to see if helped, weekly x 4, then monthly x 6 months

Ibrutinib was given orally daily.

Enrollment criteria were these HR patients
Most patients Rai 3 or 4
Had average of 2.5 prior RXs
B2M elevated
50% 17p
33% 11q
80% unmutated

FINDINGS

As expected ALC showed rise at first then fell after months
Hgb climbed
Only 2 patients off study, or 38 of the 40 patients are still on study
Dramatic shrinking of nodes within weeks.
At 3-6 months more than 50% decrease in node size. No difference in 17p responses.
Same with shrinking spleen
At 3-6 month, 1 CR, ORR was 83%, 2 with SD
ADVERSE EVENTS:
20% diarrhea
Bone achy, No increased infections.
BIOMARKERS
CCL3 CCL4  too high at start, fell with Rx

That's it.

38 out of 40 doing well in the highest risk patients. That's amazing.