That is why a drug such as Opdivo can be approved - and on an accelerated basis - with just a two month MOS increase over best historical SOC results. So of course Opdivo presents "no cure" for the malady - in this case lung cancer - but rather, just an incremental increase in overall survival - with its own set of AE's - and only for that small footprint of lucky folks who actually respond to the treatment.
No. In the entire population it showed a few months improvement. In the patients it worked well in, much more.
Yes, of course it is not a cure. Neither is Bavi.
And the AEs were not as bad as the chemo arm from a practical (patient QOL) perspective.
So if Bavi "performed as expected" as CJ reiterated, and achieving that expectation was designed by Dr. Garnick to allow the FDA to grant approval - as CJ also reiterated - then Bavi most certainly should be approved.
So bavi added to chemo did not live longer than chemo, therefore it should be approved because Opdivo (w/o chemo) only lived 2 months longer than chemo. That argument is a bit illogical.
Re your "futility" statement above: If the Sunrise trial had simply seen a control arm result {9.4 months} exactly the same as seen in the Opdivo trial, do you have any doubt that Bavi would not be approved RIGHT NOW ?
It is a certainty it would NOT be approved right now.
Even in the rosy hypothetical of 11.5 months vs 9.5 it could not possibly be approved before next year. The first look had no efficacy halt built in. The second would have data right about now, and it takes months to get through the process. And I doubt 2 months would have triggered the 2nd look anyway.
Reality:
Bavi failed in SUNRISE. If running an auto race at 185mph is "performed as expected" but came in last, it is not good.
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