Merck and Moderna: mRNA melanoma vaccine extends remission in key study
Merck and Moderna announced positive initial phase three results for a melanoma vaccine, with shares of both companies rising in premarket trading.
Merck and Moderna announced positive initial phase three results for a melanoma vaccine, with shares of both companies rising in premarket trading.
Merck and Moderna announced positive initial results from a phase three clinical trial of a personalized mRNA cancer vaccine on Wednesday, marking a crucial step toward filing for regulatory approval of the therapy in the U.S. The study involved over 1,100 patients with high-risk or advanced melanoma, all of whom had their visible tumors completely surgically removed beforehand. Specifically, the trial enrolled 1,137 high-risk patients with stage IIB to IV melanoma.
Following the announcement, Merck's shares rose more than one percent in premarket trading, while Moderna's shares surged over ten percent. According to market data, Moderna's stock jumped as much as 60 percent within the first hour of trading, at one point reaching $103.60. Merck rose 7.5 percent in premarket. The combination of the personalized vaccine and Merck's immunotherapy Keytruda met the study's key objectives, significantly extending the period without melanoma recurrence compared to treatment with Keytruda alone. The therapy also further reduced the likelihood of cancer spreading to distant parts of the body. The companies did not disclose exact figures for the improvement in recurrence-free survival but confirmed that the trial met both its primary and secondary endpoints.
Jane Healy, head of early oncology development at Merck, emphasized that patients often face a lingering fear of cancer recurrence after diagnosis and surgery. "It is particularly important that the combination of the vaccine and Keytruda showed a clinically significant improvement over Keytruda alone, which represents the standard of care for certain melanoma patients," Healy said. Professor Georgina Long, the study's lead investigator and medical director of the Melanoma Institute Australia, stated: "Today's results represent a pivotal moment for adjuvant melanoma treatment. This is the first phase 3 study to show that intismeran, a treatment designed based on the unique mutational 'fingerprint' of a patient's tumor, in combination with pembrolizumab, can reduce the risk of disease recurrence or death compared to Keytruda alone."
These results build on positive findings from the phase two trial that the companies presented earlier this year, which also demonstrated benefits of combining the personalized vaccine with Keytruda in high-risk melanoma patients after surgery. In January, the companies announced that in the mid-stage trial, the combination of the vaccine and Keytruda reduced the risk of recurrence or death by 49 percent after five years. The phase three study will continue to evaluate other outcomes, with overall survival being particularly significant.
Melanoma accounts for only about one percent of all skin cancers but is responsible for the vast majority of deaths related to this group of diseases. According to the American Cancer Society, approximately 112,000 people are diagnosed with melanoma annually in the U.S., and about 8,500 die from the disease. A particular concern is the possibility of recurrence after surgery. Most melanoma recurrences occur within the first two to three years after initial treatment and tumor removal.
The vaccine is custom-made for each patient, targeting specific mutations found in the tumor. Moderna analyzes the mutations in an individual patient's tumor and produces a personalized mRNA vaccine based on them, which is then administered in combination with Keytruda. The goal is to teach the immune system to recognize specific markers on tumor cells and attack them. This immune response is then combined with Keytruda, a drug that helps the immune system better recognize and attack cancer cells. In the trial, patients received up to nine doses of the personalized vaccine over approximately one year, and the companies noted that no new safety concerns were reported.
For Moderna, the outcome of this study also carries significant business implications. Leerink Partners analyst Mani Foroohar described the phase three results as a potentially pivotal event for the company's stock. Barclays analysts estimate that the therapy could generate around $3 billion in revenue from melanoma treatment alone by 2035. After significant growth during the COVID-19 pandemic, Moderna is trying to demonstrate that its mRNA platform can be successfully applied much more broadly than just infectious disease vaccines. The company recently received FDA approval for a flu vaccine and is developing experimental vaccines against norovirus, Lyme disease, and other diseases.
Merck and Moderna are also testing the same vaccine in other tumor types, such as non-small cell lung cancer, bladder cancer, and kidney cancer. If positive results are replicated in other cancers, this technology could open up an entirely new category of personalized therapies for oncology. For Merck and Moderna, the next key steps are full efficacy data, overall survival results, and regulatory decisions. According to estimates, the vaccine could receive approval as early as 2027, depending on regulatory review.
Merck and Moderna plan to present more detailed results at one of the upcoming international medical conferences, while it is not yet known when they might file for approval of the therapy in the U.S.
