Avid Bioservices Inc (CDMO)

[freethemice]

Abraxane in Advanced Pancreatic Cancer (APC). Also see my post on Abraxane in NSCLC
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=83655317

Combination of Abraxane and gemcitabine improves survival of patients with pancreatic cancer
Published on November 17, 2012
A new cancer drug combination demonstrated significant improvement in overall survival of late-stage pancreatic cancer patients compared to those receiving standard treatment, according to results of a Phase III clinical trial led by physicians from Scottsdale Healthcare's Virginia G. Cancer Center Clinical Trials, a partnership with the Translational Genomics Research Institute (TGen).
Physicians at the Virginia G. Piper Cancer Center at Scottsdale Healthcare were first to design a clinical trial to determine the safety, tolerability and effectiveness of nab-paclitaxel (Abraxane) in combination with the standard drug gemcitabine in patients with advanced pancreatic cancer. Results of that multicenter study chaired by Dr. Daniel Von Hoff were encouraging enough that it led to one of the largest international studies ever done in pancreatic cancer, with 861 patients. Full results are expected to be presented at the American Society of Clinical Oncology (ASCO) 2013 Gastrointestinal Cancers Symposium in Jan. 24-26 in San Francisco.
http://www.news-medical.net/news/20121117/Combination-of-Abraxane-and-gemcitabine-improves-survival-of-patients-with-pancreatic-cancer.aspx

Tomorrow we will find out what the survival numbers look like. I thought I would look at the phase I/II trial of Abraxane in APC which led to the phase III trial.
Gemcitabine plus nab-paclitaxel is an active regimen in patients with advanced pancreatic cancer: a phase I/II trial.
Von Hoff DD, Ramanathan RK, Borad MJ, Laheru DA, Smith LS, Wood TE, Korn RL, Desai N, Trieu V, Iglesias JL, Zhang H, Soon-Shiong P, Shi T, Rajeshkumar NV, Maitra A, Hidalgo M.
http://www.ncbi.nlm.nih.gov/pubmed/21969517

The first thing to note is that the phase I/II trial was a single-arm, non-randomized, open-label trial, with a total of 67 patients.
At the dose selected for the phase III trial, 125 mg/m^2, there were 44 patients. Of those 44 patients 50% had PS = 0, and 50% had PS = 1.
From the paper:
Efficacy Results
Survival. In patients treated at the MTD of 125 mg/m2 of nabpaclitaxel
(n  44), the median PFS was 7.9 months (95% CI, 5.8 to
11.0 months), median OS was 12.2 months (95% CI, 8.9 to 17.9
months; Fig 1A), and the 1-year survival was 48%.

The last paragraph from the paper:

Although the results of this clinical phase I/II study are promising,
as with any nonrandomized study, patient selection may have
influenced the outcome, and validation by a larger randomized trial is
necessary. Given the favorable safety profile and the encouraging
antitumor activity of the nab-paclitaxel plus gemcitabine regimen, a
phase III study comparing gemcitabine plus nab-paclitaxel and gemcitabine
alone has been initiated.

We will see how this MOS translates to the phase III trial, which is a open-label, randomized trial of Abraxane + gemcitabine vs. gemcitabine.
http://www.clinicaltrials.gov/ct2/show/NCT00844649?term=abraxane+pancreatic+cancer&no_unk=Y&rank=19