Avid Bioservices Inc (CDMO)

[nuke661]

ex,
Thanks for responding. I'm glad we are on the same page. It bothers me when I think I know something to be correct and then have someone with your experience say something to the contrary.

With respect, I sorta kinda do and sorta kinda don't agree with your statement:

...the 17 was not within the responder group. It was in the PD-L1 positive group.

The FDA Opdivo approval letter clearly stated this:

Additionally, 19 percent of those treated with Opdivo experienced a complete or partial shrinkage of their tumors, an effect that lasted an average of 17 months, compared to 12 percent among those taking docetaxel, which lasted an average of six months.

It seems clear to me that the FDA letter is stating that the ENTIRE Opdivo trial arm had 19% responders (complete or partial response) and to have a duration of response you first must have a response. So only responders can have a duration of response. Therefore the 17 month average duration of response number can only be applied only to the responder group. Whether the responders were due to strongly expressed PD-1 or not really doesn't matter when applying the 17 month number. However, I would agree that Opdivo's MOA indicates that the responders were more than likely responders due to their strongly expressed PD-1.

In summary this is how I see the Opdivo vs. SOC (Docetaxel) data. Opdivo clearly and impressively outperformed Docetaxel in the duration of response (Opdivo's 17 months vs Docetaxel's 6 months) for those that show a response but the number of responders was "slightly, marginally, a little bit more, a whole lot more, etc..." (anyone can chose their descriptor, it's a subjective thing anyway) because the percentage of responders in the Opdivo arm was only 7% greater (19% Opdivo vs 12% Docetaxel). Or, to say it a more typical pharmaceutical horn blowing way, Opdivo had a 60% (19/12=1.6) increase in number of responders. IMO, for 2nd line NSCLC ANY increase is great. Opdivo also had a clear and significant increase in MOS over Docetaxel 12.2 months vs. 9.4 months.

However, when you compare the Opdivo data to Bavi phase II data Opdivo can only be said to be equivalent or only SLIGHTLY superior to Bavi not superior. Bavi's response rate was 16% vs. Opdivo's 19% and Bavi's MOS was trending in the 12 to 13 month range prior to having to butcher it all up conservatively to mend the damage done by CSM's sabotaging of the phase 2 trial and proceed to Phase 3. Even after doing that the Bavi MOS was in the 11.? something month range, not that far from the Opdivo published 12.2 month MOS. It seems very clear to me that Opdivo ought to be shaking in its boots because Bavi+Docetaxel is clearly a threat all by themselves to equal Opdivos MOS numbers and if Bavi delivers on its pre-clincal ability to induce inate immunity to cancer then Opdivo's numbers are going to fade fast in impressiveness (all IMO).

The important thing for patients is not Bavi vs Opdivo but, as Steve King keeps saying, is how many more patients can be turned into responders from non-responders and how can we increase the duration of survival.