Avid Bioservices Inc (CDMO)

[freethemice]

I don't think it was an oversight, or telling. I think it was simply a very small trial (70 patients) in a very nasty
disease. In all the trials that have been done in pancreatic cancer in the last 15 years only three have
shown a statistically significant increase in MOS. Nobody should have expected this small trial
to show such a result. It was obviously not designed to do so. There was a trial in 2007 that did
show statistical significance of a 0.33 month (10 days) increase in MOS. That was the Moore et al. trial
with Tarceva + gem vs. gem.
Erlotinib Plus Gemcitabine Compared With Gemcitabine Alone in Patients With Advanced Pancreatic Cancer:
A Phase III Trial of the National Cancer Institute of Canada Clinical Trials Group
Results
A total of 569 patients were randomly assigned. Overall survival based on an intent-to-treat
analysis was significantly prolonged on the erlotinib/gemcitabine arm with a hazard ratio (HR) of
0.82 (95% CI, 0.69 to 0.99; P
.038, adjusted for stratification factors; median 6.24 months v 5.91 months).
One-year survival was also greater with erlotinib plus gemcitabine (23% v 17%; P
.023). Progression-free
survival was significantly longer with erlotinib plus gemcitabine with an estimated HR of 0.77
(95% CI, 0.64 to 0.92; P
.004). Objective response rates were not significantly different between the arms,
although more patients on erlotinib had disease stabilization. There was a higher incidence of some
adverse events with erlotinib plus gemcitabine, but most were grade 1 or 2.
Conclusion
To our knowledge, this randomized phase III trial is the first to demonstrate statistically
significantly improved survival in advanced pancreatic cancer by adding any agent to gemcitabine.
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Here is the OS for the 100 mg cohort. For this group the increase in the MOS was 0.42 months with an HR = 0.81.

The other two trials were the FOLFIRINOX trial (342 patients) and the recent Abraxane trial (861 patients).
The FOLFIRINOX trial did not add the 4 chemo drugs to gem, rather it was those 4 drugs in the
treatment arm and gemcitabine in the control arm.