Moderna shares more than doubled Wednesday after its personalized mRNA cancer vaccine, developed with Merck, succeeded in a late-stage melanoma trial, delivering one of the most important clinical milestones in the company’s post-Covid pipeline.
MRNA stock surged about 155% to $160.46, after earlier jumping more than 100%, lifting Moderna’s market value above $60 billion. Merck shares also gained about 10.6% to $149.44.
The Phase 3 INTerpath-001 trial tested Moderna’s intismeran autogene, formerly known as mRNA-4157 or V940, together with Merck’s blockbuster cancer drug Keytruda in patients whose high-risk melanoma had been surgically removed.
Moderna Cancer Vaccine Clears Major Phase 3 Test
The combination met the study’s primary endpoint of recurrence-free survival and a key secondary endpoint measuring survival without the cancer spreading to distant parts of the body.
Moderna and Merck said both improvements were statistically significant and clinically meaningful compared with Keytruda alone. No new safety signals emerged. The study enrolled 1,137 patients with stage IIB-IV melanoma.
The companies have not yet released detailed Phase 3 figures, meaning investors still do not know the precise reduction in recurrence or how large the benefit was between the treatment and control groups. The study will continue to assess overall survival, and full results are expected to be presented at a future medical meeting.
Intismeran is individually manufactured for each patient. Tumor tissue is sequenced to identify mutations, and an mRNA therapy coding for as many as 34 neoantigens is then produced to train the immune system to recognize cancer cells.
Earlier Data Set a High Bar for the Phase 3 Trial
The positive result builds on encouraging Phase 2b data. At five years of follow-up, intismeran plus Keytruda reduced the risk of recurrence or death by 49% and the risk of distant metastasis or death by 59% compared with Keytruda alone.
Those results had already raised expectations for the larger Phase 3 study, but confirmation in a late-stage trial substantially reduces clinical-development risk.
For Moderna, the result is especially important as the company looks beyond its Covid vaccine business for durable growth. The company has been cutting costs and developing several new products while maintaining a goal of reaching cash breakeven around 2028.
The cancer program could become a major new franchise. Moderna and Merck currently have nine Phase 2 and Phase 3 studies evaluating intismeran across melanoma, lung, bladder and kidney cancers.
The next major test will be the full Phase 3 dataset. Moderna and Merck said they plan to discuss the results with regulators, potentially moving the personalized cancer vaccine closer to its first commercial approval.
