Avid Bioservices Inc (CDMO)

[freethemice]

While we wait for the second-line NSCLC survival I thought I would get back to the first-line NSCLC trial.
It brings up a topic I have mentioned before. Avastin had no survival benefit for women in this trial,
the primary trial used for approval, even though almost half of the patients were women. Lung cancer
is now the biggest cancer killer of women. I think this could be an advantage for Bavi if it can confirm
the 12.4 month MOS reported from the phase IIa trial (equal to Avastin + CP) but work as well for women as for men.

This is from the National Cancer Institute on Avastin in first-line NSCLC http://www.cancer.gov/cancertopics/druginfo/fda-bevacizumab

First-Line Treatment of Non-Small Cell Lung Cancer (NSCLC)
On October 11, 2006, the FDA granted approval for a labeling extension for bevacizumab (Avastin®, Genentech, Inc.), administered in combination with carboplatin and paclitaxel, for the initial systemic treatment of patients with unresectable, locally advanced, recurrent, or metastatic, non-squamous, non-small cell lung cancer. This recommendation is based on the demonstration of a statistically significant improvement in overall survival (OS) in patients receiving bevacizumab with carboplatin and paclitaxel compared to those receiving carboplatin and paclitaxel alone.

The primary trial (E4599) supporting this approval was a randomized, active controlled, open label, multi-center clinical trial evaluating bevacizumab plus carboplatin and paclitaxel (n=434) versus carboplatin and paclitaxel alone (n=444). (See the protocol summary.)

Patients with squamous histology, mixed cell tumors with predominant squamous cell histology, central nervous system metastases, gross hemoptysis (>1/2 tsp red blood), or unstable angina and those receiving therapeutic anticoagulation were excluded from the trial. Patients with squamous cell histology were excluded based on four patients with life-threatening or fatal hemoptysis among 13 patients with squamous cell histology enrolled in a randomized, active-control, phase II study (AVF0757g) who received chemotherapy with bevacizumab.

Among the 878 randomized patients, the median age was 63, 46 percent were female, no patients had received prior chemotherapy, 76 percent had stage IV disease, 12 percent had stage IIIB disease with malignant pleural effusion, 11 percent had recurrent disease, and 40 percent had an ECOG performance status of 0.

OS, the primary endpoint, was significantly longer in patients receiving bevacizumab in combination with paclitaxel and carboplatin as compared to those receiving paclitaxel and carboplatin alone (median OS 12.3 vs 10.3 mos; hazard ratio 0.80, p=0.013 stratified log rank test). Although a consistent effect was observed across most subgroups, in an exploratory analysis, evidence of a survival benefit was not observed in women (HR 0.99; 95 percent CI 0.79, 1.25).