A combination of Moderna’s personalised cancer vaccine, intismeran autogene, and MSD’s stalwart oncology drug, Keytruda (pembrolizumab), has significantly extended recurrence-free survival (RFS) in patients with melanoma post-resection in a Phase IIb study.
This is evidenced by the five-year data collected from the mid-stage KEYNOTE-942 trial (NCT03897881), in which the mRNA cancer vaccine plus Keytruda slash the risk of recurrence or death by 49% compared with Keytruda alone.
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This positive effect on RFS was observed in patients with high-risk melanoma who were given intismeran autogene plus Keytruda following surgical tumour removal.
The five-year outcome of the KEYNOTE-942 trial mirrors the results observed at three years, as the combination also reduced the risk of recurrence or death by 49% at this timepoint.
William Blair analyst Myles Minter noted that this is likely due to intismeran autogene’s impact on the adaptive immune response, meaning that responders at three years will “continue to show tumour control in year five”.
“We view the maintenance of tumour regression protection as a signal of durable tumour control, but we will need to wait for a full data presentation to verify this conclusion,” Minter added.
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By GlobalDataBoth Moderna and MSD, known as Merck & Co in the US, will present further data from the KEYNOTE-942 study at a future medical conference.
To further progress intismeran autogene-Keytruda’s clinical development, MSD is running the global Phase III V940-001 study (NCT05933577), which is currently assessing the combination’s potential in the adjuvant melanoma setting.
mRNA cancer vaccines edge closer to market
If intismeran autogene were to gain US regulatory approval, it would become the first mRNA cancer vaccine on the market for melanoma – marking a potential shift in the treatment paradigm for this indication.
According to Biswajit Podder, oncology and haematology analyst at GlobalData, if the combination’s benefit were to be confirmed in Phase III, it would likely “evolve adjuvant care from anti-PD-1 therapy towards a combination of anti-PD-1s and personalised immune priming strategy” amongst the high-risk population.
However, if the combination were to make it to market, Podder noted that its uptake would be heavily influenced by real-world feasibility and access, which could be impacted by the cancer vaccine’s individualised nature, as well as the limited window post-surgery in which it can be administered.
Political tensions leave future of mRNA vaccines uncertain
Though mRNA vaccines have displayed promise in the oncology field, their road to market may not be straightforward. This is due to the growing scepticism around their safety amongst high-ranking US health agency employees – including the US Health Secretary, Robert F Kennedy Jr (RFK Jr).
In August 2025, RFK Jr took steps to deprioritise mRNA vaccine research by revoking $500m in funding awarded by the Biomedical Advanced Research and Development Authority (BARDA). This move impacted 22 mRNA vaccine development programmes.
This decision was met with praise from the US Food and Drug Administration’s (FDA) lead biologics regulator, Vinay Prasad, who called RFK Jr’s call to deprioritise mRNA vaccine research “wise” due to his concerns around the long-term safety of drugs in this modality.
In conversation with Clinical Trials Arena’s sister publication, Pharmaceutical Technology, experts warned that these shifts could mark the politicisation of decisions around mRNA jabs, despite the technology becoming a “breakthrough” in the world of vaccinations.
Despite the growing fear around US regulatory challenges for mRNA vaccine developers, GlobalData forecasts that intismeran autogene will become a blockbuster seller for Moderna, bringing in $2.3bn in 2031.
GlobalData is the parent company of Clinical Trials Arena.
