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md1225

11/18/15 7:17 AM

#243091 RE: exwannabe #243081

ex Bavi will be used in combo to make the PD-1 more efficacious in my opinion we are NOT competing but if we were the data we need to best is the intent-to-treat (ITT) population, Opdivo significantly improved OS compared to docetaxel. Treatment with Opdivo resulted in a 27 per cent reduction in the risk of death, amounting to a 2.8-month difference at the median (12.2 months vs. 9.4 months).

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nuke661

11/18/15 9:48 AM

#243102 RE: exwannabe #243081

ex,

I respectively disagree with your statement:

Opdivo was 17 months O/S in the entire population



Per the FDA approval letter for Opdivo:

Those treated with Opdivo lived an average of 12.2 months compared to 9.4 months in those treated with docetaxel. 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.



The way I read this FDA letter is that the entire population was 12.2 months not 17 months as you stated. The population that strongly expresses PD-1, they are the ones that had an average of 17 months.

The way I see it, based on the original Phase II data, Bavi + chemo alone has an excellent chance to equal and/or beat Opdivo when looking at an entire NS-NSCL treatment population without winnowing the population to just have strongly expressed PD-1 patients.