SouthernWorldwide.com – A groundbreaking injectable therapy is demonstrating significant promise in reducing the risk of melanoma recurrence over a five-year period.
This personalized mRNA cancer therapy, known as intisomeran autogene, when used in conjunction with the immunotherapy drug KEYTRUDA (pembrolizumab), is the result of a collaborative effort between Merck and Moderna.
The compelling findings from the phase 2b KEYNOTE-942 study were formally presented at the American Society of Clinical Oncology (ASCO) Annual Meeting, held in Chicago on May 27.
Following an extensive follow-up period of approximately five years, the combined therapy demonstrated a notable 49% reduction in the risk of melanoma recurrence or death when compared to the use of pembrolizumab alone.
The study involved the analysis of data from 157 patients diagnosed with high-risk stage 3 and 4 melanoma, all of whom had undergone surgical removal of their cancer. These participants were divided into two distinct treatment groups: one received the combination therapy, while the other was administered pembrolizumab as a standalone treatment.
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These revealed findings indicated that the benefits observed in the combination therapy group were not only substantial but also sustained and durable over the extended follow-up period.
Intisomeran autogene is meticulously designed by identifying specific mutations present within a patient’s own tumor. The core objective of this personalized approach is to effectively educate the patient’s immune system, enabling it to recognize the characteristics of cancer cells so it can then mount an attack against them.
According to the researchers involved in the study, intisomeran has proven to be well-tolerated by patients, exhibiting a manageable safety profile.
The most frequently reported side effects associated with the personalized mRNA vaccine when administered alongside KEYTRUDA included fatigue, pain at the injection site, chills, fever, and headaches. Importantly, the researchers found no evidence of new long-term safety concerns and reported no severe vaccine-related adverse events.
This promising combination therapy is currently undergoing evaluation in a phase 3 study, which represents the final and conclusive stage of clinical trials for confirming efficacy and safety.
In a statement released by Merck in January, Dr. Kyle Holen, Moderna’s senior vice president and head of development for oncology and therapeutics, highlighted that these data underscore the “potential for prolonged benefit… in patients with resected high-risk melanoma.”
He further emphasized the company’s ongoing commitment to investing in their oncology platform due to such encouraging outcomes, which clearly illustrate the significant potential of mRNA technology in the realm of cancer care.
Dr. Marjorie Green, senior vice president and head of oncology, global clinical development at Merck Research Laboratories, also shared her perspective. She noted that for a considerable number of patients battling stage 3 or 4 melanoma, there exists a “significant risk of recurrence following surgery.”
She added that demonstrating the longer-term potential of intisomeran autogene and KEYTRUDA to mitigate this risk of recurrence for specific melanoma patients represents a truly meaningful milestone in cancer treatment.
The companies cited these encouraging five-year follow-up results and pointed towards the upcoming late-stage INTerpath trial results, conducted in collaboration with Moderna, which will explore the therapy’s efficacy across several hard-to-treat cancers.
