Avid Bioservices Inc (CDMO)

[Big On Tarvy]

Survival Data is the Key for Bavi Cancer.

Great find Mojo. Thanks so much for the link to Avastin’s survival chart. The conclusion of this Abstract is also worth repeating:

“Conclusions: Initial therapy of metastatic breast cancer with paclitaxel plus bevacizumab prolongs progression-free survival, but not overall survival, as compared with paclitaxel alone.” http://content.nejm.org/cgi/content/full/357/26/2666

IMO, Mgmt. will wait to do a Bavi BP license until enough time has passed to show that the survival line for GA and India Bavi patients is trending above the Avastin survival line shown in the chart Mojo posted yesterday.

Comparing the PFS trend lines for Bavi vs. Avastin may be intriguing, but the big money lies in proving that Bavi’s second MOA (i.e. stimulating an immune response to the tumor) results in longer survival times.

The rationale for insurance reimbursement of a drug like Avastin that only improves PFS but does not improve overall survival rates is already in serious question. Bavi’s big commercial bang will come from improving survival times as compared with Avastin, not from improving PFS times as compared with Avastin.

While I love the earlier PFS charts you have made, Mojo, and while it would temporarily appease my curiosity if Mgmt. would give us more of the Georgia PFS data that we know they have, having this PFS data could be quite misleading since the really big and certain indicator of Bavi’s potential to broadly replace Avastin in the marketplace will come only from long-term survival data.

In post 30156 I said that “Georgia Bavi results with Docetaxel are good (MAYBE as good as Avastin).” Realist interprets this as a negative remark. All I meant to say is that we won’t know whether Bavi is “commercially” superior to Avastin until the survival data starts to draw a trend line above the line in the Avastin chart Mojo posted yesterday.

As of the PR on July 2, 2008, 14 of 15 GA breast tumor patients had completed the 8 week protocol. As of late January and late June 2009, six-month and 12-month survival data will be available for these patients.

Thus, in first-half of 2009 we will see whether Bavi’s dual MOA results in superior survival times as compared to Avastin. Take another look at Mojo’s chart. If 100% of our 14 evaluable patients are still alive in January (the 6-month mark), and if 90% of these patients are still alive in late June (the 12-month mark), Bavi is on the way to becoming the new SOC for cancer.

This need to wait for 6-month and 12-month survival data is, IMO, the reason why S.K. said in his presentation this week, in Slide 34, that GA breast cancer results will be updated in 1H’09. Nothing else really matters.