What he is discussing is a situation mostly relevant to Provenge. Now that Abi (Zytiga) moved into the pre-chemo space, Provenge's indication is getting pinched. Provenge and Zytiga are not generally considered compatable because Zytiga is administered with prednisone, an immune supressant. As Provenge depends on an immune response for efficacy, the two do not mix well. One of Dendreon's solutions is to expand the indication by encouraging potential patients to get scanned sooner with more sensitive tests. To be eligible for insurance coverage, Provenge users are required to have radiologically evident metasteses. Dendreon is trying to carve out enough space to get patients treated before they get put on Zytiga.
The better solution would have been to do an additional phase 3 to move Provenge into an earlier indication where it would not have to compete. Theoretically immunotherapies work best with an uncompromised system and a low disease burden. My suspicion is that DNDN did not have enough confidence in their drug to risk rolling the dice again. Help is on the way, Enzalutamide (MDV3100) does not require concommittant prednisone and should not present problems with Provenge coadministration.
How much weight do you figure we should attribute to this first readout on the Abi/Cabo combo?
As we already know the trial will further accommodate a pre-chemo setting, isn't it likely that we may not actually get too much info on efficacy, synergy, or integrative response other than a projected P2 ( hopefully P3) dosing schedule. The decision to move Cabo into pre-chemo along with the Abi upgrade can only be taken w/ positivity, right? Do you have any conceptual reservations w/ this?
BTW/FYI - I can't verify this at this writing...but I'm gonna pass it along anyway.
I have it on "fair" authority that the luncheon symposiums at the NCCN annual meeting may be webcast via satellite live-feed. I'll try further to verify, and -if possible - locate a website for sign-in.
I'm still awaiting verification...but I'm fairly sure it's gonna be a go...