The CEO of Moderna, Inc., Stephane Bancel, said last week that his company may introduce a new mRNA (messenger ribonucleic acid) biologic to treat melanoma cancer as early as 2025. Moderna has been working in partnership with Merck, Inc. to develop a mRNA-based shot that targets skin cancer cells. The product, mRNA-4157 (V940), would be used in combination with Merck’s PD-1 inhibitor cancer drug Keytruda (pembrolizumab).1 2
Phase 2b Clinical Trial Results Reported
On June 3, 2024, Moderna and Merck announced the results of a phase 2b clinical trial using RNA-4157/Keytruda as an adjuvant therapy. The randomized trial, which consisted of 157 high-risk melanoma cancer patients, reportedly showed a “clinically meaningful improvement in recurrence-free survival,” reducing the risk for recurrence of or death from melanoma by 49 percent, versus using Keytruda alone. It also reportedly showed that the patients had a survival rate of 96 percent, compared with 90.2 percent with Keytruda alone. Additionally, some 75 percent of the patients survived without cancer recurrence after receiving the mRNA-4157/Keytrudo combo shot, compared with 55.6 percent of melanoma cancer patients who only received Keytruda.2 3 4
With regard to the safety of RNA-4157/Keytruda, the most commonly reported side effect of the combi shot was fatigue—a grade 3 adverse event reported by 61 percent of the patients. The U.S. Department of Health and Human Services (HHS) defines grade 3 adverse events as…
Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL.5
ADL stands for Activities of Daily Living, which refers to bathing, dressing and undressing, feeding self, using the toilet, taking medications, and not bedridden. Grade 4 adverse events are “life-threatening consequences; urgent intervention indicated.”5
Kyle Holen, MD, senior vice president of Moderna, noted, “The KEYNOTE-942/mRNA-4157-P201 study was the first demonstration of efficacy for an investigational mRNA cancer treatment in a randomized clinical trial and the first combination therapy to show a significant benefit over pembrolizumab alone in adjuvant melanoma.”2
The National Cancer Institute (NCI) defines adjuvant therapy as…
Additional cancer treatment given after the primary treatment to lower the risk that the cancer will come back. Adjuvant therapy may include chemotherapy, radiation therapy, hormone therapy, targeted therapy, or biological therapy.6
Phase 3 Clinical Trial Underway
On July 26, 2023, Moderna and Merck announced the launch of a phase 3 trial to assess the mRNA-4157/Keytruda combo shot. The trial aims to enroll 1,089 high-risk melanoma cancer patients, with final results due in 2029. The mRNA-4157/Keytruda combo is also being evaluated in several phase 3 trials to study its effect on non-small cell lung cancer and cutaneous squamous cell carcinoma.2 3 7
Data analytics and consulting firm GlobalData plc of England projects that RNA-4157/Keytruda will be launched in 2027 and will be licensed for use in the United States. The company estimates revenue for Moderna and Merck from sales of the product will surpass $1 billion by 2030.3
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Click here to view References:1 Yoshida K. Moderna to launch skin cancer vaccine as soon as 2025: CEO. Nikkei Asia Sept. 13, 2024.
2 Gervais GB. Coming Soon: The First mRNA Vaccine for Melanoma? Medscape Jan. 17, 2024.
3 GlobalData. ASCO24: Moderna/MSD’s cancer vaccine may transform melanoma landscape. Pharmaceutical Technology June 4, 2024.
4 Reuters. Moderna-Merck skin cancer vaccine shows survival benefit in long-term follow-up. Reuters June 3, 2024.
5 U.S. Department of Health and Human Services. Common Terminology Criteria for Adverse Events (CTCAE). Nov. 27, 2017.
6 National Cancer Institute. Adjuvant Therapy.
7 Carvalho T. Personalized anti-cancer vaccine combining mRNA and immunotherapy tested in melanoma trial. Nature Medicine Aug. 16, 2023.
5 Responses
I’d rather die than take any mRNA poisons.
What is your opinion of the mRNA platform technology being used like this? I’ve heard that platform delivery system is part of the problem and what causes people to have reduced immunity overall and is dangerous.
A “biologic” to treat cancer by using the concept that giving you a little cancer via mRNA will stimulate your immune system to attack more cancer. Gee, what could go wrong?
I have mixed feelings about this. Could we see a complete list of ingredients please?
Sharing a bit of historical understanding from my years of following healthcare trends. As many already know, monoclonal antibodies have been overall very helpful in extending life for cancer patients with relatively low side effects compared to conventional chemotherapy. For close to two decades, attempts to develop mRNA treatments for cancer in human clinical trials (over 2000 published) were unsuccessful, often setback by horrendous side effects that were at times life threatening. A pro-industry scientific review paper published in 2018 suggested that finding ways to use mRNA for vaccination was desirable as much lower doses would be used compared to cancer treatment, thus potentially overcoming one of the setbacks. This news about pairing mRNA with monoclonals makes sense as a strategy to get mRNA into cancer treatment protocols riding on the coattails of monoclonals. I imagine the target mRNA dose for the combination therapy is much lower than the original standalone trials. FWIW, the first early example of using an individual’s immune system to clear out a cancer was accomplished by a physician mixing their melanoma tissue with their white blood cell fractions and then reinjected which was successful in only a few cases but shockingly good for a terminal patient. Perhaps this method could have been improved yet the establishment was seeking an industrial application so that’s how the funding was allocated. A similar industrial-driven scenario occurred in autologous stem cell treatments as described in a lecture by Dr Arnold Caplan the “father of mesenchymal stem cell research” who passed away earlier this year in January at the age of 82.