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Msg  18231 of 18357  at  2/23/2023 3:20:44 PM  by


The following message was updated on 2/23/2023 3:30:33 PM.

More on cancer vaccine

Following is a clip from SA transcript of 4Q CC. Hoge speaking. Red from me.
As you noted, the Phase 2b study that we’ve run is a randomized study compared against, really, the standard of care with KEYTRUDA alone, and has already shown a quite significant benefit of 44% reduction of the rate of recurrence and – or death. And that study is ongoing, and so we’re continuing to follow over time and conduct additional interim analyses. And it’s possible that those – in fact, we would hope that those data mature and continue to get stronger and stronger. And so it is entirely possible that in our discussions under breakthrough with the FDA and others that we will come up with a path forward for beginning the filing process based on that Phase 2 and potentially proceeding with accelerated approval.
Well the first red highlight is directed at results getting stronger with the passage of time. Note how he started the second sentence: "And it's possible that those..." Then he changed the start to..., "in fact, we would hope..".   I believe they already know it gets stronger because they have a subset of participants who were already at two years post treatment when the last participant completed the first year, which triggered the first read.
The second red highlight indicates that FDA may allow the approval process to start with the P2 trial. Later on in the transcript, Hoge talked about FDA wanting a confirmatory P3 trial under way to act on P2 data, but I got the impression that if the P2 data is compelling enough and a P3 was under way, approval based on P2 is not impossible.
There is more to the Keytruda/mRNA trial than has been publicly released.

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Msg # Subject Author Recs Date Posted
18232 Re: More on cancer vaccine dar200 0 2/23/2023 3:42:17 PM
18236 Re: More on cancer vaccine dar200 2 3/1/2023 11:08:23 AM

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