Moderna and Merck report Phase 3 success for personalized mRNA melanoma vaccine with Keytruda

A personalized mRNA melanoma vaccine developed by Moderna and Merck shows promise in reducing recurrence and spread. Iparraguirre Recio · Moment/Getty A late-stage trial found that a personalized mRNA therapy for melanoma outperformed Keytruda alone on two important measures of treatment success. The experimental treatment is tailored to the unique mutations in each patient’s tumor to help the immune system recognize and attack cancer cells. Experts say the findings are encouraging, but detailed results are still needed to understand the treatment’s potential benefits and safety. Moderna and Merck announced August 19 that a phase 3 trial of their experimental personalized mRNA cancer therapy, intismeran, in combination with Keytruda (pembrolizumab), met two key endpoints in people with high risk melanoma. The trial met its primary endpoint of recurrence-free survival, meaning the combination reduced the risk of melanoma returning or death compared with Keytruda alone. It also met a key secondary endpoint of distant metastasis-free survival, which measures the time before cancer spreads to another part of the body or death. The companies have not yet released detailed efficacy or safety results from the phase 3 trial. Previous phase 2b results found that intismeran plus Keytruda (pembrolizumab) was associated with a 49% lower risk of melanoma recurrence or death and a 59% lower risk of distant metastasis or death compared with Keytruda alone. “Today’s results represent a landmark moment for adjuvant melanoma treatment,” Georgina Long, AO, PhD, Medical Director of Melanoma Institute Australia (MIA) and the study’s principal investigator, said in a press release.   “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,” she said.  How does a personalized melanoma vaccine work?  Intismeran is an investigational, custom-made vaccine being studied in people with high risk, resected cutaneous melanoma. The vaccine is manufactured individually for each patient. Intismeran uses messenger RNA (mRNA) technology to encode up to 34 patient-specific neoantigens. Neoantigens are new proteins that form when mutations occur in tumor DNA. They are identified by sequencing each person’s tumor. The vaccine is designed to train T cells to recognize and target these neoantigens, priming the immune system. Keytruda is a PD-1 checkpoint inhibitor that helps the immune system recognize and attack cancer cells. One way to think about the combination is that Keytruda releases the brakes on the immune system, while intismeran gives it directions to find the cancer. The phase 3 trial is still ongoing, and intismeran remains investigational and has not been approved by the Food and Drug Administration (FDA). According to the Moderna and Merck press release, the companies plan to submit the findings to regulatory authorities and present the full results at an upcoming medical meeting. Implications for melanoma treatment While the phase 3 results are encouraging, more detailed data are needed to understand how much the combination could improve melanoma treatment. “These first Phase 3 findings for intismeran in combination with KEYTRUDA as adjuvant therapy reinforce the promise of a more personalized approach to cancer treatment,” Dean Y. Li, MD, president of Merck Research Laboratories, said in a press release. Kim Margolin, MD, medical oncologist and medical director of The Borstein Family Foundation Melanoma Program at Providence Saint John’s Cancer Institute in Santa Monica, CA, who was not involved in the study, said the announcement is encouraging, but cautioned that it is difficult to assess the clinical significance without seeing the detailed data. “Several important questions remain. First, we need to establish how much additional benefit the personalized mRNA therapy provides compared with established adjuvant immunotherapy. A statistically significant improvement is important, but the magnitude of the benefit and its durability are ultimately what matter to patients and clinicians,” Margolin said. “Safety is another major consideration. Immune-based treatments can produce immune-related adverse events because activation of the immune system can sometimes result in attacks against normal tissues. We would need to know whether adding an individualized neoantigen vaccine increases the frequency or severity of these toxicities, including potentially new autoimmune complications,” she added. The findings suggest that personalized mRNA therapies could eventually play a role in melanoma treatment. However, more detailed efficacy and safety data from the phase 3 trial are needed to determine the potential clinical benefits and risks.

Moderna and Merck are developing a treatment using an mRNA-based cancer vaccine called intismeran that is designed to be tailored to individual patients based on unique mutations within their tumors.

Moderna Merck Cancer Vaccine Clears Phase Trial How Personalised mRNA Tech Fights Melanoma

Moderna and Merck are developing a treatment using an mRNA-based cancer vaccine designed to be tailored to individual patients based on unique mutations within their tumors.

Moderna and Merck say their personalized mRNA melanoma vaccine significantly reduced both cancer recurrence and spread in a late-stage trial. The treatment could reach patients as soon as next year if regulators approve it. Reuters reports: Moderna developed the vaccine with Merck and tested it together with immunotherapy drug Keytruda, a widely used treatment for melanoma. [...] This is the first positive late-stage trial result for an mRNA cancer vaccine, which trains a patient's immune system to fight tumors by targeting specific mutations in those cells and the first such study to show that adding a treatment to Keytruda worked better than that therapy alone. Similar approaches are being tested against lung, breast and pancreatic cancers. [...] The cancer treatment combines Merck's Keytruda with a made-to-order mRNA vaccine from Moderna that is based on an analysis of mutations found in the patients' own tumors. The trial enrolled 1,137 high-risk patients with stage IIB-IV melanoma that had been surgically removed. Volunteers were randomized to receive up to nine doses of Keytruda plus the personalized vaccine or Keytruda alone for about one year. The companies said no new safety signals have emerged in the trial. In January, the companies announced results of a mid-stage trial of the treatment showing that it reduced the risk of recurrence or death by 49% after five years. Karen Knudsen, CEO of the Parker Institute for Cancer Immunotherapy, said the Moderna results could signal a new era for treating solid-tumor cancers. "The positive hit here leads us into truly this next phase in immunotherapy," Knudsen said. "This is an auspicious start -- this is where things begin." Moderna shares more than doubled on the news, adding about $30 billion to its market value. Read more of this story at Slashdot.

Moderna shares more than doubled Wednesday after it announced initial results from a study of an experimental cancer treatment that would be the first of its kind if approved by regulators. Moderna and Merck are developing a treatment using an mRNA-based cancer vaccine called intismeran that is designed to be tailored to individual patients based […]

Moderna shares rallied about 135% to $148.02 on Wednesday after its personalised mRNA cancer vaccine, developed with Merck, reduced the risk of melanoma recurrence and spread when combined with Keytruda in a late-stage trial, Reuters reported.The stock rose as high as $149.63 after closing the previous session at $62.96.Interim results from the ongoing study showed that the treatment, Intismeran, met its primary goal of reducing cancer recurrence and its secondary objective of preventing tumours from spreading to other parts of the body, compared with Keytruda alone, Reuters reported.The results mark the first successful late-stage trial of an mRNA cancer vaccine. It is also the first study to show that adding another treatment to Keytruda worked better than Keytruda alone in patients whose melanoma had been surgically removed.Merck shares gained 11% to $150/14 in early trading.The findings could help ease investor concerns about the companies’ long-term growth prospects. Moderna has been seeking growth beyond its COVID-19 vaccine, while Merck is preparing for Keytruda, its blockbuster cancer therapy, to lose patent protection later this decade, according to the Reuters report.William Blair analyst Myles Minter said the interim results put both companies in a strong position to seek regulatory approval. He added that the findings were also encouraging for ongoing studies of the vaccine in other types of cancer.Merck research and development chief Dean Li told CNBC that the companies expected to begin discussions with regulators within the next few months.Barclays analysts estimated last month that the therapy could generate about $3 billion in melanoma-related sales by 2035.Pricing remains undecidedJP Morgan analysts told Reuters the launch of Intismeran as an adjuvant treatment for melanoma would be crucial to Moderna’s return to profitability.The therapy combines Merck’s Keytruda with a made-to-order Moderna mRNA vaccine designed using an analysis of mutations found in each patient’s tumour.The trial enrolled 1,137 high-risk patients with stage IIB to stage IV melanoma that had been surgically removed. Participants were randomly assigned to receive up to nine doses of the personalised vaccine alongside Keytruda, or Keytruda alone, for about one year.The companies said no new safety concerns had emerged during the trial.In January, they released five-year results from a mid-stage study showing that the combination reduced the risk of cancer recurrence or death by 49%.Moderna CEO Stéphane Bancel said the companies had not yet decided on a price for the treatment because the latest data had become available only a few days earlier.Unlike some personalised cell therapies, the treatment does not use a patient’s own cells, which could allow the manufacturing process to be scaled up and costs to be reduced, Bancel said.Melanoma is the deadliest form of skin cancer. More than 1.5 million people in the United States were living with the disease in 2023, according to the National Cancer Institute(Disclaimer: This article is based on inputs from agencies. These do not represent the views of The Economic Times)

Moderna and Merck announced today that their personalized mRNA-based cancer vaccine, combined with Merck’s immunotherapy medication Keytruda, met initial goals in a late-stage trial.  The ongoing mRNA cancer vaccine study involves 1,137 patients with high-risk melanoma that has been surgically removed. In early results, the trial met its primary target of reducing the risk of cancer recurrence and its secondary target of reducing the risk of cancer spreading to other parts of the body. How are markets reacting to the news? Shares of Moderna Inc (Nasdaq: MNRA) were up over 120% in early trading on Wednesday. As of this writing, the stock was trading at a high point it hasn’t seen since mid-2024. Merck & Co Inc (NYSE: MRK) saw its stock price rise a more modest 11%. Why the announcement is notable It’s the first positive Phase 3 result for a personalized cancer therapy, for any mRNA-based cancer therapy, and for any treatment to show meaningful improvement over using Keytruda alone. After a tumor is surgically removed, scientists sequence and analyze the DNA to identify its unique mutations. Then they build a personalized vaccine, called Intismeran Autogene, tailored to the patient’s unique mutations, training the immune system to recognize and attack those cancer markers. It’s paired with the immunotherapy medicine Keytruda to help the body better detect and fight off cancer cells. “These Phase 3 findings represent a pivotal moment for the field of cancer research,” Stéphane Bancel, CEO of Moderna, said in a statement. “For many years, the idea of creating an mRNA treatment designed specifically for an individual patient’s cancer was aspirational. We are now helping turn that vision into a reality.” Merck and Moderna are testing the vaccine in nine ongoing trials across multiple tumor types and stages of disease, including lung cancer, bladder cancer, and kidney cancer.

Holy Grail In Cancer Treatment? Moderna Erupts After Melanoma Vaccine Late-Stage Trial Success Moderna's shares soared as much as 83% in premarket trading in New York after its personalized cancer vaccine, developed in collaboration with Merck & Co., reduced the risk of melanoma returning in a large, late-stage trial. The result marks the first positive Phase 3 trial for a personalized cancer vaccine by any company.  The study met its primary endpoint by showing that the cancer vaccine, called intismeran autogene, combined with Merck's blockbuster immunotherapy Keytruda, improved recurrence-free survival compared with Keytruda alone. The study also met a secondary endpoint by reducing the risk of cancer spreading to other parts of the body. Professor Georgina Long, the study's principal investigator, medical director of Melanoma Institute Australia, and chair of Melanoma Medical Oncology and Translational Research at the University of Sydney, wrote in a statement: Today's results represent a landmark 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 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 with KEYTRUDA alone. Intismeran in combination with pembrolizumab has the potential to establish a new treatment paradigm in the adjuvant melanoma setting, helping patients remain cancer-free for longer. Moderna and Merck did not disclose exact figures showing how much the therapy improved recurrence-free survival. The trial remains ongoing. Additional details will be presented at an upcoming medical meeting, and the vaccine could receive approval as early as 2027, depending on the regulatory review. As of 0700 ET, Moderna shares were up 60% and trading around $100 per share. Short interest represents 13.5% of the float, equivalent to 49.8 million shares. Merck shares are up 7% in premarket as well.  Melanoma is the most serious form of skin cancer. About 112,000 people are diagnosed annually in the US, and about 8,500 die from the disease, according to the American Cancer Society. "Therapeutic vaccines have been something of a holy grail in cancer. People have been trying to do this for, you know, over 100 years in one way or another," Jane Healy, head of oncology early development at Merck, said in an interview with Bloomberg several weeks ago. She noted that one potential benefit of the personalized shot would be to extend survival without significantly increasing side effects. Tyler Durden Wed, 08/19/2026 - 07:40