Moderna‑Merck melanoma vaccine shows Phase 3 success as FDA greenlights mRNA flu shot
A late‑stage trial involving more than 1,000 patients with surgically removed melanoma reported that a personalized mRNA vaccine given with Merck's Keytruda produced a statistically significant increase in recurrence‑free survival compared with Keytruda alone. The vaccine is created from each patient’s tumor tissue and its genetic code is assembled by an algorithm that selects tumor‑specific neoantigens. Shortly after the trial results, Moderna announced a $2 billion convertible‑debt offering.
Earlier in August, the FDA approved Moderna’s mRNA influenza vaccine for adults 50 and older. Analysts note the potential impact on oncology while also raising questions about cost and access.
How this was covered
- Centrist coverage is the most divided on this story
Why it matters
The results could broaden the role of mRNA and AI‑driven personalization in cancer treatment and add a new therapeutic option for melanoma patients.
How this story developed
- Aug 19 Moderna shares soar as experimental melanoma vaccine shows promising results
- Aug 19 Moderna’s stock surged after the trial data were released.
- Aug 20 Interim Phase 3 data indicated the vaccine satisfied the primary endpoint of recurrence‑free survival and a key secondary endpoint of distant metastasis‑free survival.
- Aug 24 Moderna’s share price dropped more than 25% after an earlier surge following the trial announcement.
- Aug 28 Companies announced positive topline results from the ongoing phase‑3 trial of the personalized mRNA melanoma vaccine with Keytruda.
- Aug 31 The FDA approved Moderna’s mRNA influenza vaccine for adults 50 and older.
