Merck and Moderna have ‘lot of exploring to do’ after initial cancer vaccine success — SkimNews
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- Merck and Moderna announced in August that their personalized mRNA cancer vaccine (intismeran autogene) significantly delayed recurrence and metastatic disease in melanoma patients in a large Phase 3 trial, and are preparing to file for approval.
- Moderna President Stephen Hoge said at the STAT Summit that the companies "have a lot of exploring to do and need to prioritize where we explore," as Merck R&D chief Dean Li outlined a strategy targeting "hot tumors" where Keytruda has historically worked best.
- The vaccine works in combination with Merck's blockbuster immunotherapy Keytruda and is manufactured by sequencing individual tumors and using an algorithm to select up to 34 mutant proteins to flag to the immune system.
- Merck and Moderna are running adjuvant trials in lung, kidney, and bladder cancer, with small studies underway in pancreatic and gastric cancer, and are exploring standalone use in very early-stage tumors.
- Dean Li contrasted the companies' approach with "other people" who "may not have the advantage" of their expertise and chose to pursue cold or metastatic tumors — an apparent reference to mRNA rival BioNTech, which has some early promising data but also notable failures.
- Hoge said Moderna and Merck could improve the vaccine's algorithm by analyzing the immune systems of the "now several thousand people" in their Phase 3 program, calling it "a real privilege to have all that information."
- Patient Gary Keblish, a public school teacher diagnosed with melanoma in 2019, is still teaching after receiving the vaccine in a trial, and spoke at the summit via video comparing the experience to Ms. Frizzle's Magic School Bus.
Why it matters: With intismeran autogene headed for filing after melanoma success, Merck and Moderna plan to expand into lung, kidney, and bladder cancers — settings where Keytruda already works. Their choice to avoid cold tumors, where BioNTech has stumbled, trades potential reach for a clearer regulatory path built on Keytruda's 15 years of trial data.
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