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Merck and Moderna report higher melanoma-free survival with vaccine combination

Merck and Moderna said their personalized mRNA vaccine, when added to Keytruda, reduced the risk of melanoma recurrence and cancer-related death by 42% in newly released Phase 3 data. Two years after treatment, 82% of patients receiving the combination were cancer-free, compared with 70% receiving Keytruda alone.

AI-assisted synthesis · Based on 4 outlets' reporting · Article text read from 1 of 4 outletsHow it's made

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4 outletsLatest reporting 2 min read
Coverage: Mostly CenterL 1 · C 3 · R 0
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Photo: Fletcher / Wikimedia Commons (CC BY 4.0)

What happened

Key facts

  • Merck and Moderna said adding their personalized mRNA-based vaccine to Keytruda reduced the risk of melanoma recurrence and cancer-related death by 42%.
  • In the Phase 3 trial, 82% of patients receiving the vaccine combination were cancer-free two years after treatment, compared with 70% receiving Keytruda alone.
  • The trial included 1,137 adults with surgically removed stage 2B to 4 melanoma, according to Merck and Moderna.
  • The vaccine is customized to each patient's tumor and is intended to help the immune system identify and attack cancer cells remaining after surgery.
  • The vaccine has not been approved by the U.S. Food and Drug Administration; the companies plan to include the Phase 3 results in a submission to the agency.
  • The treatment could be approved in 2027 or later, according to the report.

The brief

Merck and Moderna said newly released Phase 3 results show that adding their personalized mRNA cancer vaccine to Keytruda reduced the risk of melanoma returning and cancer-related death by 42%. The findings concern adults whose melanoma had been surgically removed, and the companies plan to include the data in a submission to the Food and Drug Administration.

The trial included 1,137 adults with stage 2B to 4 melanoma. Two years after treatment, 82% of participants who received the vaccine alongside Keytruda were cancer-free, compared with 70% of those treated with Keytruda alone. The figures describe the two groups’ outcomes at that point in the study. Merck makes Keytruda, the immunotherapy drug used in both groups.

The vaccine, developed by Merck and Moderna, is tailored to an individual patient’s tumor. The companies say it is designed to help the immune system recognize and attack cancer cells that remain after surgery, with the aim of preventing the cancer from returning. The reported 42% reduction combines the risk of melanoma recurrence and cancer-related death.

The trial results also provide the separate two-year cancer-free proportions for the combination and Keytruda-only groups. The figures come from the companies’ account of the Phase 3 results. The companies will use the Phase 3 data in a package submitted to the FDA.

Approval is not established by the results themselves: the treatment could receive FDA approval in 2027 or later, according to the reported account. The FDA decision is therefore the next regulatory step identified. Melanoma kills about 8,000 people annually in the United States, according to the Centers for Disease Control and Prevention.

The reported trial findings concern patients with surgically removed stage 2B to 4 melanoma and compare adding the personalized vaccine with Keytruda alone; they do not describe outcomes for people outside the trial population.

Why it matters

  • For adults with surgically removed stage 2B to 4 melanoma, the reported comparison was 82% cancer-free at two years with the vaccine and Keytruda, versus 70% with Keytruda alone.
  • The companies reported a 42% reduction in the combined risk of melanoma recurrence and cancer-related death.
  • The CDC figure cited is about 8,000 melanoma deaths annually in the United States.
  • The vaccine is personalized to each patient's tumor and is intended to help the immune system identify cancer cells remaining after surgery.

What to watch next

  • Whether Merck and Moderna submit the Phase 3 results to the FDA as part of the treatment package.
  • Whether the FDA approves the treatment; the reported possible timing is 2027 or later.
  • How the FDA evaluates the reported two-year cancer-free rates: 82% with the combination and 70% with Keytruda alone.

How it's being covered

Coverage analysisShow details
5 source articles · 4 unique outlets
Outlet political mix: Mostly Center· 1 Left · 3 Center
Where the outlets are based: US/Canada 100%
Outlet political mix
Mostly Center
Left
Center
Right
1 outlet
3 outlets
0 outlets
The marker shows coverage balance: each unique outlet counts once.
Geography
Where the outlets covering this story are based.
4 unique outletsDominant coverage: US/Canada
Coverage imbalance
  • Coverage is currently concentrated among Center-rated outlets (3 of 4 rated sources); comparatively few Right-rated outlets have published on the event.
  • Coverage is currently concentrated among outlets based in US/Canada (4 of 4 geographically-identified sources).
How we measure coverage

How outlets' accounts compare

Updat3 does not yet have enough full reports to compare how outlets framed this story.

Timeline

Developments from this story's sources, dated background we compiled and fact-checked, and our earlier coverage. Each row says which.
  1. Katalin Karikó and Drew Weissman published research on nucleoside-modified mRNA that reduced innate immune activation.
    Background · compiled and fact-checked by Updat3
  2. The FDA approved ipilimumab for advanced melanoma.
    Background · compiled and fact-checked by Updat3
  3. The FDA granted accelerated approval to pembrolizumab (Keytruda) for advanced melanoma.
    Background · compiled and fact-checked by Updat3
  4. Moderna and Merck began their collaboration on personalized cancer vaccines in 2016.
    Background · from our historical context
  5. The FDA approved pembrolizumab as adjuvant treatment after surgery for certain patients with melanoma involving lymph nodes.
    Background · compiled and fact-checked by Updat3
  6. Moderna and Merck reported initial phase 2b results for their personalized mRNA vaccine with pembrolizumab after melanoma surgery.
    Background · compiled and fact-checked by Updat3
  7. The FDA granted breakthrough therapy designation to Moderna and Merck’s personalized mRNA cancer vaccine for melanoma.
    Background · compiled and fact-checked by Updat3
  8. Moderna and Merck announced the phase 3 INTerpath-001 trial of their personalized mRNA vaccine with pembrolizumab.
    Background · compiled and fact-checked by Updat3
  9. Merck and Moderna published KEYNOTE-942 findings in The Lancet.
    Background · compiled and fact-checked by Updat3

How we got here

In December 2023, Merck and Moderna published results from the randomized Phase 2b KEYNOTE-942 trial: among 157 people with high-risk melanoma removed by surgery, personalized mRNA-4157 (V940) plus pembrolizumab was associated with a 44% lower risk of recurrence or death than pembrolizumab alone after a median follow-up of about two years. The U.S.

Food and Drug Administration approved Keytruda for advanced melanoma in 2014, and in February 2019 approved it as adjuvant treatment after surgery for certain patients with melanoma involving lymph nodes. Moderna and Merck began their collaboration on personalized cancer vaccines in 2016.

Original sources

5 articles from 4 outlets · US/Canada · Show all

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