Jam, I appreciated your comment and I also just now commented on that site. Here are my words:
While I have no doubt Halozyme will need ph3 results for any chance at registration, I also have no doubt the presented data is much more positive than what we knew about PAG in pancan last week. Last week we had stage 1 data from Higorani’s ASCO presentations. The data was weird and poor, especially with OS due, largely we presume, to 40% of the active cohort stopping PEG. There was also M&M associated with the increase in TEEs in the PAG arm. Those who follow this company were always ready to chuck the stage 1 data out the window. So, we waited for Stage2. Halozyme had to present the entire data set but AF and others perhaps don’t realize that only the new and cleaner data of stage 2 (on Lovenox) mattered much to shareholders.
Unfortunately, the n is nowhere near large enough with stage 2 to make stat-sig. But the numbers make sense in the context of historical data. Consider these generally accepted numbers: (RR/PFS/OS)
G alone: 7-9.4% / 3.3-3.7 mos / 6.8 mos
AG: 23% / 5.5 mos / 8.5 mos
Mod FOLFIRINOX: 32% / 6.4 mos / 11.1 mos
Now, know that these numbers are for all stage3/4 pancan and the third of patients who have high HA status consistently do less well than those with low HA.
The stage 2 PAG numbers we saw yesterday look excellent in light of what we knew last week. Thus, the increase in SP. I anticipate now more rapid enrollment in the ph 3 trial and have more confidence going forward in its outcome, both PFS and OS.
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