Moderna is developing a cancer vaccine that is expected to dramatically cut cancer survivors’ risk of death or recurrence. At least, trial data indicates that this is the case.
To treat melanoma — the type of skin cancer with the highest death rate — doctors start by surgically removing as much of the cancer as possible. Afterwards, they often do another treatment, such as chemo or radiation therapy, to kill any cancer cells they missed.
“Even if a person is cancer-free after this, there’s always a chance of the melanoma coming back, and certain types are considered high-risk for recurrence, including ones that are particularly thick or that had metastasized (spread to other parts of the body) prior to treatment,” notes Freethink.
To deal with that problem, Moderna and drugmaker Merck are developing an mRNA-based cancer vaccine, mRNA-4157 (V940), for those patients who have had high-risk melanomas removed:
The vaccine works by instructing the body to make up to 34 “neoantigens.” These are proteins found only on the cancer cells, and Moderna personalizes the vaccine for each recipient so that it carries instructions for the neoantigens on their cancer cells.
The idea behind the vaccine is that, by prompting the body to make these proteins, it can prepare the immune system to quickly identify and attack any new cancer cells bearing them, preventing recurrence….In 2022, they reported that the combo therapy reduced high-risk patients’ risk of recurrence or death by 44% compared to only Keytruda in the two years after treatment.
They’ve now announced that people who received both therapies were 49% less likely to experience recurrence or death a median of three years after treatment compared to people in the Keytruda-only group. They were also 62% less likely to experience distant metastasis or death.
“The durability of the responses is really strong — they’re essentially rock solid through this time,” says Moderna President Stephen Hoge. “This is a pretty significant improvement, a pretty dramatic improvement over standard of care with just Keytruda alone.”
“We think that in some countries the product could be launched under accelerated approval by 2025,” says Stephane Bancel.
The KEYNOTE-942 study was small, with fewer than 200 participants, but Moderna and Merck have already launched a phase 3 trial for the combination cancer therapy in which more than 1,000 people with high-risk melanoma will participate.
The firms are also looking to apply their discovery to other cancers, launching a phase 3 trial testing the cancer vaccine in people with non-small cell lung cancer — and if those trials have good results, it might not be long before the personalized therapy reaches patients in some countries.
But in the U.S., it will take longer to become available. America’s Food and Drug Administration can take many years to approve life-saving drugs and medical devices.
Jake Selliger describes how he is “dying of squamous cell carcinoma, and the treatments that might save [him] are just out of reach,” due to the FDA, which routinely takes many years to approve life-saving medical treatments.
“The FDA is responsible for more deaths on an annual basis than any other government agency. Here’s one of its victims,” noted Paul Matzko of the Cato Institute. Researchers are “curing multiple cancers right now,” yet “the FDA is acting like it’s business as usual” and dragging its feet on approving cures. Selliger’s demise shows how the “FDA is much more” harmful “than your political opponents you think you hate,” argues Richard Hanania of the University of Texas.
Here is one story of how the FDA needlessly delays the approval of lifesaving drugs, from “Why the FDA Has an Incentive to Delay the Introduction of New Drugs”:
“In the early 1980s, when I headed the team at the FDA that was reviewing the NDA for recombinant human insulin, . . . we were ready to recommend approval a mere four months after the application was submitted (at a time when the average time for NDA review was more than two and a half years). With quintessential bureaucratic reasoning, my supervisor refused to sign off on the approval—even though he agreed that the data provided compelling evidence of the drug’s safety and effectiveness. ‘If anything goes wrong,’ he argued, ‘think how bad it will look that we approved the drug so quickly.’”
FDA employees commonly take years to approve life-saving drugs. That results in the deaths of hundreds of thousands of people who could have been saved by earlier approval of those drugs. For example, at least a hundred thousand people died waiting for the FDA to approve beta blockers. One of the FDA officials involved in delaying their approval was John Nestor. Nestor was notorious for following rules in ways designed to frustrate and inconvenience other people. As the Journal of American Physicians and Surgeons notes:
Nestor had the unique habit of getting into the leftmost lane [on the highway] with his cruise control set at 55 mph, the posted speed limit. He would drive at this speed regardless of what came up behind him. Cars would zoom up close to his rear bumper; drivers would flash their lights and blast their horns,some swerving around him on the right while giving him the finger—none of this fazed Nestor in the least. As he explained it, 55 mph was the law, and he had a right to drive in whichever lane he chose: “Why should I inconvenience myself for someone who wants to speed?”
Nestor followed this rigid mindset in his work at the FDA. He was very good at using agency red tape, and minor risks or side effects of drugs, as an excuse to avoid approving life-saving drugs.
The FDA didn’t approve a home test for HIV until 24 years after it first received an application. According to an FDA advisory committee, the test “holds the potential to prevent the transmission of more than 4,000 new HIV infections in its first year of use alone.” That means thousands of people likely got infected with AIDS as a result of the delay in approving it. As Roger Parloff of Fortune notes, the FDA’s delay in approving the home HIV test is a “scandal.” It likely caused the deaths of thousands of people, given the mortality rate from AIDS. It may also have caused billions of dollars in additional costs for taxpayers, given that AIDS is a costly and debilitating disease to treat, resulting in treatment costs of perhaps $600,000 per AIDS sufferer.
The FDA keeps the most effective sunscreens off the U.S. market. The FDA blocks new innovations that will protect your skin. Insider reports that the “U.S. has awful sunscreen compared to Asia and Europe. Strict, decades-old FDA rules are to blame: European and Asian sunscreens boast stronger and smoother formulas than sunscreens found in the US. That’s because the FDA is slower to approve new UV filters compared to other countries.”
