Moderna, Merck Cancer Vaccine Succeeds in Trial

Moderna, Merck Cancer Vaccine Succeeds in Trial

Engraving of a vaccine vial and syringe

The News

Merck and Moderna said Wednesday that their personalized mRNA cancer vaccine, given alongside Merck's immunotherapy Keytruda, met its main goal in its first-ever late-stage trial in melanoma patients.

The combination significantly extended the time patients lived without their melanoma returning, compared with Keytruda alone, and also cut the risk of the cancer spreading to distant parts of the body, the companies said.

Investors moved fast. CNN reported Moderna shares up 60% in premarket trading, at $103.60, with Merck up 7.5%; CNBC, reporting earlier in the premarket session, had Moderna up more than 10% and Merck up more than 1%.

The Trial

The phase three study enrolled 1,137 high-risk patients with stage IIB-IV melanoma whose detectable cancer had been completely removed by surgery, according to CNN. CNBC put the enrollment at more than 1,100 patients with higher-risk or advanced melanoma.

Patients were randomized to receive up to nine doses of Keytruda plus the personalized vaccine — called Intismeran — or Keytruda alone, over roughly one year. The companies said no new safety signals emerged.

The vaccine is built to order: it is based on an analysis of the mutations found in each patient's own tumor, rather than a single one-size-fits-all shot.

Timeline

January 2026

Merck and Moderna announced mid-stage results showing the regimen reduced the risk of recurrence or death by 49% after five years.

Earlier in 2026

The companies presented five-year phase two data on the same regimen, the foundation for the late-stage study.

Wednesday, August 19, 2026

The companies announced that the phase three trial met its primary goal of reducing recurrence and its secondary goal of preventing the cancer from spreading. Moderna's stock jumped in premarket trading.

Reactions

Dr. Jane Healy, Merck's head of oncology early development, told CNBC that melanoma patients are "stuck having to deal with the new gravity of that diagnosis and then undergo uncomfortable treatments like surgery, and after that, they're worried about their cancer coming back."

Healy called it "very exciting" that the therapy delivered a "clinically meaningful improvement" over Keytruda — the current standard of care for melanoma — and said it was well tolerated, with side effects similar to vaccines people routinely get for other diseases.

"We think [the results are] very meaningful for patients with this disease and really the potential of what it can mean for other patients for cancer in future trials with this particular new class of therapy," she said.

Wall Street had flagged the readout as decisive. Leerink Partners analyst Mani Foroohar wrote in a June note that the phase three results were a make-or-break event for Moderna's stock, CNBC reported. Barclays analysts said last month they expect the therapy could generate about $3 billion in melanoma sales by 2035, according to CNN.

What's Next

The trial is still running and will continue to measure other outcomes, including whether the combination helps patients live longer overall.

Merck and Moderna said they will present the full results at an upcoming international medical meeting and share them with regulators. It is not clear when they plan to file for approval in the United States.

The two companies are also testing the vaccine in trials against other tumors, including non-small cell lung cancer, bladder cancer and renal cell carcinoma.

More

Melanoma accounts for only about 1% of skin cancers but causes the large majority of skin cancer deaths, CNBC reported. Most recurrences show up in the first two to three years after initial treatment and surgery. More than 1.5 million people in the U.S. were living with melanoma in 2023, according to the National Cancer Institute.

For Moderna, the stakes run past this one disease. The company has been diversifying beyond its COVID-19 vaccine — adding an FDA-approved flu shot while developing experimental vaccines for norovirus and Lyme disease — and analysts say its valuation already assumes the personalized cancer vaccine eventually works in more than melanoma.

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