The Moderna headquarters is seen on Nov. 30, 2020, in Cambridge, Massachusetts. Moderna has applied for FDA approval to authorize its COVID-19 vaccine for emergency use.
The long-awaited cancer vaccine revolution is getting a little closer to reality. New data from Moderna Inc. and Merck & Co. suggest that after decades of failures, researchers are finally figuring out the right way to design a vaccine that can teach immune cells how to recognize and combat tumors.
In December, the companies said that when used in concert with Merck’s cancer immunotherapy Keytruda, Moderna’s mRNA cancer vaccine reduced the risk of certain skin cancers from returning or patient deaths by 44% compared with Keytruda alone.
That number justly generated a lot of excitement. It’s the first time an mRNA-based cancer vaccine has proven itself in a randomized study, and with an unambiguously positive outcome. If that result holds up in larger trials, it would be a huge advance both for the mRNA technology behind COVID vaccines and for the field of cancer vaccines in general.
But there are a lot of steps between achieving early, positive data for a subset of melanoma patients and developing a widely accessible, cost-effective treatment. Among the more daunting challenges: The vaccine needs to be tailored to the genetic makeup of an individual patient’s tumors.
The study was small, enrolling just 157 people at high risk of their late-stage skin cancer returning. Still, even if the results are slightly less dramatic in a bigger study, the vaccine could make a difference for patients. “That would be a substantial change,” translating into long-term remissions, says Julie Bauman, director of the George Washington University Cancer Center. Bauman led an earlier study of Moderna’s cancer vaccine.
The study enrolled melanoma patients who had undergone surgery to remove any signs of their cancer. Unlike vaccines the public is used to taking — mass-produced shots that aim to prevent people from catching a contagious disease like the flu or polio, Moderna’s cancer vaccine instead is intended to keep the disease from returning. It does that by training immune cells to recognize as dangerous proteins found on a patient’s own tumor cells.
The hope was that the vaccine would amplify the already substantial benefit of Keytruda, which blocks a method that cancer cells use to hide from the immune system. Amazingly, the combination worked.
There are nearly 100,000 cases of melanoma annually in the United States, according to the American Cancer Society. While most cases are curable when detected early, more than 7,500 people die every year of the disease.
Bringing down the “needle-to-needle” time between biopsy and immunization will be critical to ensuring the treatment isn’t just promising, but practical and accessible to anyone who might benefit from it.
Perhaps the biggest question right now is whether the effect seen in melanoma can be extended to other types of cancer. Moderna Chief Executive Officer Stephane Bancel told CNBC recently that the company is moving aggressively into Phase 3 studies with the belief that “anywhere Keytruda works, this should work.”
Keytruda, meanwhile, is approved to treat a long list of cancers beyond melanoma—so many, in fact, that it’s expected to bring in more than $24 billion in sales in 2023. Bancel suggested that the vaccine might even make possible responses in tumors where Keytruda has failed, either on its own or by acting synergistically with Merck’s drug.
That’s an optimistic claim — worth studying, but a feat that has eluded other cancer immunotherapies. Melanoma is what’s known as a “hot” tumor, or one that features many mutations and has plenty of immune cells milling about, ready to be pushed into doing their cancer-killing job. It’s reasonable to be hopeful that Moderna’s vaccine could extend Keytruda’s benefits in other hot tumors, such as those found in lung cancer.
But “cold” tumors, or ones without that crowd of immune cells ready to be activated, are a much tougher proposition. In an earlier small study of the Moderna vaccine in solid tumors, for example, none of the patients with colon cancer — a notoriously “cold” tumor — responded, Bauman says.
Another immense challenge is the very high likely cost of a personalized therapy on top of Keytruda, which on its own carries a list price of around $185,000 per year. The only upside to that hefty price tag is that the companies will be motivated to answer these questions as quickly as possible. Indeed, Bancel has said that Moderna plans to aggressively invest in cancer.
All that money flowing into Moderna’s cancer vaccine will teach the field not just about that one product, but how to design, test and use other ones. Let’s hope that’s the catalyst for the true cancer vaccine revolution, one that could convert cancer from a potentially lethal illness into a chronic, stable disease.
Lisa Jarvis is a Bloomberg Opinion columnist covering biotech, health care and the pharmaceutical industry. ©2022 Bloomberg. Distributed by Tribune Content Agency.
Originally published at Lisa Jarvis