The Japan Times - Merck and Moderna's tailored cancer drug curbs melanoma recurrence in trial

Called "intismeran autogene," it is based on the same messenger ribonucleic acid (mRNA) technology behind Covid-19 vaccines.

Researchers have been working on developing mRNA treatments against cancer, but this is the first time one has shown positive results in a Phase 3 trial, the drugmakers said.

When delivered along with pembrolizumab, an immunotherapy drug and the current standard of care, intismeran autogene prevented melanoma recurrence and prevented the cancer from spreading to other organs, the companies said in a statement.

"Today marks an extraordinary milestone for Moderna, for mRNA science and, most importantly, for patients with cancer," Moderna CEO Stephane Bancel said in a statement.

The news sent shares in Moderna soaring 129 percent to $144 while Merck's stock was up more than 10 percent to $150.

The trial lasted approximately a year and involved 1,137 patients who, following surgical removal of their cancers, were randomized into groups, with two-thirds receiving the new treatment plus pembrolizumab, while the rest received pembrolizumab alone.

The companies said they would present their data at an upcoming international conference and begin filings with regulators for approval.

- 'Proof of principle' -

Lennard Lee, a consultant medical oncologist and assistant professor at the University of Oxford who was not involved in the trial, called the results "very encouraging," adding: "We should now look forward to seeing the complete data."

Marco Gerlinger, a consultant medical oncologist and professor at London's Barts Cancer Institute, added that beyond being good news for patients with melanoma, it was "proof of principle that personalised cancer vaccines work," but also said the press release was short on details.

It is also not yet known whether the recurrence rate will increase over a longer period, for example three years, Gerlinger said.

The treatment works by taking a sample of the patient's tumor and identifying its unique mutational signature, or "fingerprint," then using mRNA technology to fight it.

Messenger RNA technology uses synthetic molecular instructions encased in tiny fat bubbles that temporarily enter cells, causing them to produce targets that train the body’s immune system.

The technology was first conceived decades ago but came to the fore during the Covid-19 pandemic, when Moderna and Pfizer developed vaccines that were highly effective against serious forms of the illness.

Melanoma is one of the deadliest forms of skin cancer, with more than 330,000 new cases diagnosed worldwide in 2022.

"Together with Merck, we are now studying intismeran in combination with pembrolizumab and other anti-cancer therapies, and as a monotherapy, across multiple tumor types and stages of disease, including melanoma, lung, bladder and kidney cancers," said Bancel.

K.Yamaguchi--JT