Moderna's Cancer Vaccine Candidate Shines, In Melanoma Combo Trial With Keytruda... Likely Material Good News For Rahway.

This result was reported out at ASCO, but is probably not getting the full attention it deserves. The "loud part, being said softly, here" is that even if -- by some improbably dark magic, a generic clears all the US baffles to reach market before 2030 with a bio-similar to Keytruda, this all-branded combo has breakthrough clearance coming at FDA (on the strength of this data) -- and since the FDA clearance will relate exclusively to the twin brandeds, in combination. . . Merck will very likely sail into 2035 or so, largely not seriously challenged in the US markets, by any generic.

[Many know that this had been my long held view, on a likely-coming Merck "evergreening" strategy. We may leave for another day the discussion of whether this is a wise way for public policy to work, but it is how the laws and regulations function, at present. This will be deemed a new invention. Just one of my backgrounders, here.]

That is, this sort of "step-wise approvaling approach" effectively stretches out the duration of Merck's patents, since it is now clear that the combo improves efficacy -- and the FDA clearance will be for only the branded combination at first. [Thus my long offered conjecture, toward 2035 for a real US generic threat, to pembrolizumab. That conjecture is now becoming. . . fact.]

Here is Fierce on it all:

. . .During ASCO, Merck and Moderna publicly presented three-year data on the joint cancer vax in a phase 2b trial for resected melanoma. The update comes from KEYNOTE-942, a trial assessing the individualized neoantigen therapy (INT) in combination with Keytruda for 157 patients with high-risk melanoma (stage 3/4) after complete resection.

At a median follow-up of 34.9 months, mRNA-4157 and Keytruda reduced the risk of recurrence or death by 49% compared to Keytruda by itself. This compares to the two-year top-line data that found a 44% recurrence-free survival rate.

“These data are very important, because they provide a strong efficacy and durable efficacy for patients,” Barr said. “This is a therapy designed for immunologic resetting, where you're trying to create anti-tumor immune responses that are very vigorous and can be used for long-term control of the tumor.”

When examining long-term efficacy, the key is to watch for any late relapses that could occur, Barr said. Relapses would indicate that the vaccine’s initial benefit stops or dissipates over time. That hasn’t been the case for mRNA-4157 in KEYNOTE-942. . . .

Now you know -- and the stock is up, smartly, on the NYSE -- in response. And so, onward, smiling.

नमस्ते