Skin cancer is both common and deadly. Pharmaceutical companies are racing to develop new therapies to target melanoma, a form of skin cancer, using mRNA technology. And now, in a “landmark” trial, Merck and Moderna have revealed that a combined therapy using mRNA can effectively prevent melanoma from returning and meaningfully improve survival rates, according to a joint statement.
Merck and Moderna conducted a phase 3 clinical trial of a combined therapy based on two separate drugs to treat melanoma—Merck’s immunotherapy drug Keytruda (also known as pembrolizumab), and intismeran autogene, a form of mRNA therapy that works by prompting the body’s immune system to destroy cancer cells.
More than 2 percent of people will be affected by melanoma at some point in their lives. While very treatable when caught early, catching the disease in its later stages can be fatal: the five-year survival rate can drop to between 16 percent and 35 percent if it isn’t caught by the time the cancer begins to spread to other parts of the body.
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Scientists increasingly believe messenger RNA, or mRNA, technology could be a game changer in cancer treatment. The technology has become the basis of numerous proposed cancer treatments and vaccines. The drugs work by introducing pieces of mRNA that can instruct the body to build proteins that boost immunity. In the case of intismeran autogene, the therapy is highly personalized to the patient. DNA from the person’s tumor is sampled and sequenced to identify specific mutations, and then, using those data, clinicians can develop individualized mRNA drug to target the strings of amino acids that lie on a cancer cell’s surface. That prompts an immune response primed to kill the cancer cells.
Merck and Moderna said the good results mark the first successful phase 3 trial for an mRNA-based cancer treatment of this kind. The trial results, however, are yet to be published, and the drug will need to be reviewed by the U.S. Food and Drug Administration for approval before it can be deployed in the clinic.
“Today’s results represent a landmark moment for adjuvant melanoma treatment,” said Georgina Long, an oncologist at Melanoma Institute Australia and the trial’s principal investigator, in the statement. “This is the first Phase 3 study to show that intismeran, a treatment designed based on the unique mutational ‘fingerprint’ of a patient’s own tumor, given in combination with pembrolizumab can reduce the risk of recurrence or death in patients with completely resected stage IIB-IV melanoma compared to Keytruda alone.”
The announcement comes after the companies in June published the results of a five-year phase 2 trial in the Journal of Clinical Oncology in which patients with an advanced form of melanoma given both medications had better rates of the cancer going away with no recurrence, and of the cancer not spreading to other locations in their bodies, as well as increased overall survival times, compared with those given Keytruda alone.
Merck is currently recruiting participants for another phase 2 clinical trial in which some people with stage 3 or 4 melanoma will receive intismeran autogene along with Keytruda, while a different group will receive only Keytruda. The hope is to see if giving both drugs together can stop advanced melanoma from spreading or growing and if it can extend the lifespan compared to Keytruda alone.
Even with the successful trials, the drug still needs Food and Drug Administration approval. In May the agency declined to approve another treatment for advanced melanoma that showed similar promise in clinical trials.