- Moderna and Merck released detailed Phase 3 results for the mRNA-based personalized cancer vaccine intismeran autogene after partial data leaked on social media earlier the same day.
- The vaccine reduced the risk of melanoma recurrence or death by 42% when given with Merck's Keytruda versus Keytruda alone, in a trial of roughly 1,100 patients whose tumors were removed by surgery.
- The combination reduced the risk of cancer spreading to distant parts of the body or death by 38% compared with immunotherapy alone.
- Six melanoma specialists told CNBC the results represent a clinically meaningful advance that could become a standard of care for patients who undergo surgery first and have not received immunotherapy before surgery.
- The stock market reaction was negative, contrasting with the positive assessment from oncologists.
- Moderna CEO Stéphane Bancel said the company is finishing a filing with regulators and aims to get the drug fully approved next year.
- Open questions remain on whether the combination extends overall survival, the durability of benefit over longer periods, and which patients benefit most.
Quotes
“This has the potential to be a major breakthrough in melanoma treatment and also cancer immunotherapy in general that will open the door to greater outcomes for patients”
“this is the first time we're seeing that when you add something to immunotherapy, you actually boost the efficacy of the immunotherapy.”
“It's a very, very happy moment for the field, for patients”