Receiving a personalized mRNA-based cancer vaccine alongside immunotherapy lowered the risk of recurrence or death by 42% versus immunotherapy alone in a phase 3 clinical trial of patients with surgically resected stage 2B to 4 melanoma.
The vaccine, called intismeran autogene and jointly developed by Merck and Moderna, was tested in combination with Merck’s immunotherapy Keytruda after surgery as part of the phase 3 INTerpath-001 trial, according to an Oct. 22 news release from the companies. The trial enrolled 1,137 patients, about two-thirds of whom were randomly assigned to receive the vaccine. The vaccine is given in nine doses and is personalized to include up to 34 neoantigens, or proteins specific to each patient’s tumor, according to The New York Times.
The trial results were leaked online Oct. 22, The Wall Street Journal reported, two days before Merck and Moderna were expected to present the data at the European Society for Medical Oncology conference in Madrid. The leak prompted Merck, Moderna and ESMO to release the full data early.
Here are six notes on the trial results:
- In addition to lowering the risk of recurrence or death by 42%, intismeran plus Keytruda lowered the risk of distant metastasis or death by 38% compared with Keytruda alone.
- Outcomes in the vaccine group were similar to those for Keytruda alone during the first six months while patients completed the vaccine regimen. After six months, a sensitivity analysis showed a 58% lower risk of recurrence or death and a 50% lower risk of distant metastasis or death versus Keytruda alone.
- Results were generally consistent across patient subgroups, and no new safety signals emerged.
- Robert Vonderheide, MD, president-elect of the American Association for Cancer Research, told the Times the results are on par with “our biggest breakthroughs.” However, neither this trial nor an earlier phase 2 trial has yet shown whether the vaccine improves overall survival, the Times reported. Overall survival is considered the gold standard for determining whether a cancer treatment works and can be a requirement for regulatory approval.
- Merck plans to apply for regulatory approval as quickly as possible, Marjorie Green, MD, head of oncology clinical development, told the Times.
- Personalized cancer vaccines have also shown promise in small studies in pancreatic, kidney and brain cancers, but not all trials have succeeded. BioNTech ended a phase 2 colorectal cancer trial of its personalized vaccine in August after a recommendation from an independent data safety monitoring board.
Read more about the cancer vaccine landscape here.
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