Moderna and Merck said Wednesday their personalized mRNA cancer vaccine met its main goals in a Phase 3 trial targeting melanoma, marking the first time a therapy of its kind has succeeded at that stage of testing. The news sent Moderna\u2019s stock up more than 100% and lifted Merck shares as well, as investors bet on a new era for a company long defined by its Covid-19 vaccine.<\/p>\n
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The companies\u2019 vaccine, called intismeran autogene, is built from a sample of a patient\u2019s own tumor. It is designed to teach the immune system to recognize the specific mutations in that person\u2019s cancer. In the trial, patients with high-risk melanoma, one of the deadliest forms of skin cancer, who had already had their tumors surgically removed received either the vaccine plus Merck\u2019s immunotherapy Keytruda, or Keytruda alone.<\/p>\n
The trial included 1,137 patients with high-risk melanoma, cases in which the cancer had grown deep or spread to nearby lymph nodes, or in some cases, to other parts of the body. All of them had already had their tumors removed by surgery before enrolling. Patients who got the vaccine alongside Keytruda went longer without their cancer coming back or spreading than those who got Keytruda alone, meeting the trial\u2019s two main goals. <\/p>\n
The companies haven\u2019t released the exact numbers behind that improvement yet, saying only in press releases on Wednesday the results were \u201cstatistically significant and clinically meaningful.\u201d They plan to share full data at an upcoming medical conference and bring the results to regulators.<\/p>\n
The readout builds on earlier data from the same drug combination, which showed a 49% reduction in the risk of recurrence or death and a 59% reduction in the risk of distant metastasis or death, compared with Keytruda alone. Merck referenced those figures directly in Wednesday\u2019s release. Fortune<\/em> has previously covered how personalized cancer vaccines like this one work, and Moderna CEO St\u00e9phane Bancel discussed the melanoma data\u2019s earlier stages in an interview with Fortune<\/em> last year.<\/p>\nDr. Danish Nagda, an otolaryngologist who has treated head and neck melanoma patients and is founder and CEO of the healthcare startup Rezilient Health, told Fortune <\/em>just how big this news is. For patients with advanced, stage three or four melanoma, five-year recurrence-free survival today runs around 20 to 35%, he said. <\/p>\n\u201cThis potentially doubles it,\u201d Nagda said.<\/p>\n
Bancel described the trial as validation of an idea the company has pursued for years. <\/p>\n
\u201cFor many years, the idea of creating an mRNA treatment designed specifically for an individual patient\u2019s cancer was aspirational. We are now helping turn that vision into a reality,\u201d Bancel said. \u201cTogether with Merck, we have started to demonstrate the transformative potential of this technology to address critical unmet needs in the adjuvant melanoma setting.\u201d<\/p>\n
Dr. Dean Y. Li, president of Merck Research Laboratories, said the results were evidence for treating cancer earlier. <\/p>\n
\u201cBy intervening earlier in the course of disease, when many cancers are considered most treatable, the goal of adjuvant therapy given after surgery is to increase the possibility of cure for more patients,\u201d Li said. \u201cWe believe individualized neoantigen therapies have the potential to redefine how patients with completely resected stage IIB-IV melanoma are treated.\u201d<\/p>\n
\u201cToday\u2019s results represent a landmark moment for adjuvant melanoma treatment,\u201d said Georgina Long, the trial\u2019s principal investigator, medical director of Melanoma Institute Australia, and chair of melanoma medical oncology and translational research at the University of Sydney. \u201cIntismeran 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.\u201d<\/p>\n
The market reaction<\/strong><\/h2>\nInvestors responded immediately to the news as Moderna\u2019s stock more than doubled in early trading Wednesday, while Merck shares climbed as well. Merck is currently valued at roughly $371 billion and Moderna at around $62 billion.<\/p>\n
\u201cThis makes Moderna a great acquisition target,\u201d said Nagda, who sees the stock move as still behind where the platform\u2019s value should land. \u201cModerna is still incredibly undervalued. It seems like a large increase, but it\u2019s actually very much underestimating the value of a platform,\u201d Nagda told Forutne<\/em>. \u201cNow that mRNA has been used in this way to go after melanoma, what stops us from going after other targets? I bet you over the course of the next 12 to 18 months, Moderna will be significantly higher than it is right now.\u201d<\/p>\nNagda trained at the University of Pennsylvania\u2019s Perelman School of Medicine and completed his ENT residency at Washington University in St. Louis, where he treated patients with head and neck melanoma, often on combination immunotherapy regimens. He said the promise from this study comes from relaxed regulations that have helped move drugs forward, faster.<\/p>\n
\u201cThis looks good for the Trump administration\u2019s Operation Warp Speed, because this would not have existed without the mRNA vaccine coming out. This accelerated potentially a long-term solution for us to target cancers,\u201d Nagda said, adding he doesn\u2019t expect the treatment to face a difficult path to approval given how strongly oncologists are likely to embrace it for advanced melanoma patients. Fortune<\/em> has reported on declining public trust in the FDA amid political interference, a backdrop against which any accelerated filing timeline for the vaccine would play out.<\/p>\nThe results are promising<\/h2>\n
Nagda pointed to a factor he said gets little attention in coverage of the trial: rising skin cancer rates tied to climate change. <\/p>\n
\u201cMelanoma is not just an American issue. Australia has incredibly high rates of melanoma. It\u2019s a big global issue, and it\u2019s only going to get worse with climate change, as you continue to see more UV radiation and hotter climates,\u201d he said. \u201cEven right now, we\u2019re seeing sunscreen rates going down. Melanoma is going to become more and more prevalent amongst Caucasians, but also amongst other ethnicities.\u201d<\/p>\n
Nagda pointed to the safety data as another reason for optimism. In earlier trial data, reactions resolved in about 80% of the 40 patients studied, he said, calling that figure \u201chuge.\u201d <\/p>\n
\u201cThe side effect profile is minimal compared to a traditional therapeutic for patients with cancer,\u201d Nagda said.<\/p>\n
Nagda explained why the vaccine\u2019s side effect profile differs so much from older cancer treatments. Traditional chemotherapy works by exploiting the fact that cancer cells mutate, replicate, and consume energy faster than healthy cells, he said\u2014the goal is to kill the cancer before the drug kills the patient. The mRNA vaccine takes a different approach entirely. <\/p>\n
\u201cThis is going directly after the cancer cells at a direct level, targeting a unique mutational fingerprint specific to that patient\u2019s own tumor,\u201d Nagda said. \u201cIt\u2019s not just personalized across all patients. It\u2019s personalized to the patient\u2019s own tumor.\u201d This is different than traditional chemotherapy, where \u201cour goal is to kill the cancer before the drug kills the human.\u201d<\/p>\n<\/div>\n
#Modernas #Mercks #personalized #mRNA #vaccine #shows #real #promise #skin #cancer #melanoma<\/p>\n","protected":false},"excerpt":{"rendered":"
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