Landmark moment for cancer treatment as drug curbs melanoma in large trial

WASHINGTON — US drugmakers Merck and Moderna on Wednesday announced encouraging results from a large clinical trial testing a new, personalized cancer treatment for melanoma, a serious form of skin cancer. The treatment has shown success in reducing the recurrence of melanoma tumors in a late-stage trial hailed by experts as a “breakthrough.”The treatment, called intismeran autogene, is made individually for each patient using their own tumor’s DNA. It’s designed to teach the immune system to recognize and attack cancer cells unique to that person.The drug is based on the same messenger RNAtechnology behind Covid-19 vaccines.In the trial, patients who had melanoma surgically removed were given intismeran together with an existing immunotherapy drug called Keytruda. Compared to patients who received Keytruda alone, those who got both treatments were less likely to have their cancer come back or spread.Researchers have for years been trying to apply mRNA treatments against cancer, but this was the first time such a drug showed positive results in a large, late-stage clinical trial.“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 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 — the current standard-of-care drug — 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.Lennard Lee, an 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.”Oncologist Marco Gerlinger, a professor at London’s Barts Cancer Institute, added that beyond being good news for patients with melanoma, it was “proof of principle that personalized cancer vaccines work.”“I think it is fair to call it a breakthrough in the development of new cancer immunotherapies,” he added, while also noting the press release was short on details.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.