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Re: antihama post# 2667

Thursday, 10/03/2019 7:01:35 AM

Thursday, October 03, 2019 7:01:35 AM

Post# of 3283
A Zenith20 nugget from Cantor Global HCC's CC was when Ms Young asked if the trial will have some variability from MDACCs trial and one of the changes discussed was the addition of antidiarrheal prophylactic treatment. Lo and behold, Puma Biotechnology issued a PR after hours yesterday that they got a Nerlynx label addition for antidiarrheal prophylactic treatment. Keeping patients from dropping out of the trial due to severe diarrhea can only help the outcome of the Zenith 20 cohort.

The other changes to the Z20 trial as you know was getting a scan at one month which will help both ORR and Duration (just from this change Duration will be a month longer) and step down in dose from the 4mg per dose step down from 16mg in the MDACC trial to 2mg per dose in the Z20 trial. The one obvious change that they indicated may cause variability in results is having patients at multi-sites instead of just going to one site at MDACC. I discussed w Ville awhile back that I thought multi sites patients may benefit by getting more personal treatment but he didn't think so. I guess he was more correct (I still don't believe that concept totally). Anyhows, its good to know that Z20 patients are getting antidiarrheal prophylactic treatment from the getgo.