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Did Merck Make a Mistake With a Key FDA Filing?

By Keith Speights and Brian Orelli, PhD - Feb 21, 2021 at 7:03AM

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The FDA doesn't think too highly of the big drugmaker's submission for a new indication for Keytruda.

Merck (MRK 1.58%) has won multiple U.S. Food and Drug Administration (FDA) approvals for its blockbuster cancer drug Keytruda. However, the big drugmaker seems to have run into a roadblock with its latest regulatory submission for the immunotherapy. In this Motley Fool Live video recorded on Feb. 10, 2021, Motley Fool contributors Keith Speights and Brian Orelli discuss whether or not Merck made a mistake by moving forward too quickly with its FDA filing. 

Keith Speights: So an advisory committee met yesterday on Tuesday to review Merck's supplemental BLA, that's Biologics License Application, for their blockbuster immunotherapy, Keytruda, and it's in treating triple-negative breast cancer. Well, the FDA seems absolutely dead set against approving Keytruda for triple-negative breast cancer, in their briefing document, they said this, this is interesting, I'll read it here, "The FDA has repeatedly expressed concerns about the KEYNOTE-522 trial design and results to the applicant discouraged submission of the Marketing Applications."

So they discouraged Merck from even submitting this sBLA. Well, yesterday the Advisory Committee voted unanimously to defer the decision till Merck has more data. So Brian, do you think Merck should have done anything differently in the situation instead of just forging right ahead in view of the FDA's seeming adamant against approving it?

Brian Orelli: Yeah. I think it might be an issue of just timing of the data that the FDA wants versus how long it's going to take to get that data. The issue here is that Merck wanted to use pathological complete response. They are looking at really early stage breast cancer patients that are having surgery. The recurrence is going to take a long time. Then if you're going to measure survival, fortunately, for the breast cancer patients, it could take a really long time.

A difference between surgery plus then taking Keytruda versus surgery on its own, I think the issue is Merck just didn't want to wait. They were trying to get a surrogate endpoint beforehand that would give them enough data that they could convince the FDA to approve it. Then when the data didn't look that great, now you're at the point where it's only a few million dollars to submit the application so maybe we give it a whirl.

It seems like there were throwing away money at that point once the FDA is discouraging them from submitting in a marketing application. Probably it's not really worth your effort at that point. But in the large scheme of things, in the billions of dollars that Merck is earning each year, the cost of submitting an application is only a few million so maybe it's not that big of a deal to gamble. I think that's basically when it was.

They were gambling that maybe there will be enough pressure on the FDA to see that pathological complete response was enough to approve a drug. Even though I think the FDA's argument and advisory committee's agreement is that evidence for pathological complete response resulting in a better pathological complete response, result in better overall survival is not good enough for us to justify approving it with just pathological complete response.

Speights: We should note that even if the FDA gives a thumbs down, it doesn't mean that Merck can't later get approval for Keytruda in this indication. It's still a possibility that they could come back with more data and get approval.

Orelli: Yeah. I think the clinical trial might still be going on. They're still going to follow the patients and look at overall survival. I think the issue here is just that Merck was in like a waiting stage, waiting for that other data. Do you just roll the dice, and they rolled the dice and came up crap, so they'll move on and roll the dice again when their overall survival data comes in.

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