Breakthrough Designation: Moderna + Merck’sKeytruda®, In Melanoma

This is outstandingly good news, and as the smaller company by market cap, Moderna ought to see the biggest pop (after the noise of the current poor quarter is cleared out of the baffles) -- but it will be nice for Rahway, as well. Cutting risk of death by 44 per cent is. . . just a grand slam.

As ever the prices will be steep, but the outcomes. . . may approach cures. Okay -- here's the dawn's great news -- without additional delay:

. . .The U.S. Food and Drug Administration (FDA) granted breakthrough therapy designation to Moderna and Merck's personalized mRNA cancer vaccine mRNA-4157/V940, in combination with Keytruda, for the adjuvant treatment of patients with high-risk melanoma after complete resection.

The FDA's decision was backed by data from a phase 2b trial, dubbed KEYNOTE-942/mRNA-4157-P201.

In the study, the combo helped cut the risk of recurrence or death by 44%, versus Keytruda alone, in patients with melanoma, a type of skin cancer. . . .

Yep -- excellent news, indeed. . . the Merck portion of this combo, several years ago -- gave former President Jimmy Carter at least seven more very healthy years, completely free from melanoma (and a variant that had metastasized to his brain). Now you know. . . how lucky we are to be alive in this era. Smile.

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