Melanoma, “promising results” for the experimental mRNA vaccine: what is the status of the study

Melanoma, "promising results" for the experimental mRNA vaccine: what is the status of the study

An experimental mRNA vaccine has succeeded in preventing recurrence or spread of melanoma in a study conducted on patients affected by the most complex form of the disease. The announcement comes from Moderna and its partner Merck. This paves the way for a potentially innovative treatment capable of extending the lives of the thousands of people diagnosed each year with this potentially deadly skin cancer.

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«Promising results»

The phase 3 study involved patients undergoing surgery to remove melanoma, aiming to reduce the risk of recurrence. “This is the first announcement of positive phase 3 results for an mRNA-based oncology therapy,” Merck and Moderna stated in a joint press release. The mRNA vaccine, administered in combination with Merck’s immunotherapy Keytruda, achieved the key objectives of the phase 3 study conducted on over 1,100 patients with high-risk or advanced-stage melanoma, who had undergone surgery for complete removal of the tumor mass.

First phase 3 study

“For many years, the idea of creating an mRNA treatment specifically designed for an individual’s tumor was hard to imagine. Today we are helping to turn that vision into reality,” said Stéphane Bancel, CEO of Moderna. The company, along with Pfizer-BioNTech, was among the first to develop and widely commercialize an mRNA-based Covid-19 vaccine. Following the release of these results on the anti-melanoma vaccine, Moderna’s shares saw a strong pre-market rise on the New York Stock Exchange. Merck and Moderna now intend to present the data at an upcoming scientific conference and begin the process to obtain regulatory approval for the treatment.

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“Today’s results represent a milestone for adjuvant melanoma treatment. This is the first phase 3 study to demonstrate that Intismeran – a treatment developed based on the unique mutational “fingerprint” of an individual patient’s tumor – administered 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,” explains Professor Georgina Long, who led the study and is the medical director of the Melanoma Institute Australia as well as a professor of Medical Oncology of melanoma at the University of Sydney, in Merck’s statement – The combination of Intismeran and Pembrolizumab has the potential to establish a new therapeutic paradigm in the context of adjuvant melanoma treatment, helping patients remain disease-free longer.”

Increased chances of cure

“By intervening earlier in the course of the disease, when many tumors are considered more treatable, the goal of adjuvant therapy administered after surgery is to increase the chances of cure for a greater number of patients,” said Dean Y. Li, president of Merck Research Laboratories, who added, “these initial phase 3 results for Intismeran in combination with Keytruda as adjuvant therapy confirm the potential of a more personalized approach to cancer care. We believe that therapies based on personalized neoantigens have the potential to redefine treatment for patients with completely resected stage IIB-IV melanoma. Together with Moderna, we look forward to presenting the data from the “INTerpath-001” study at an international medical congress and sharing them with regulatory authorities,” he concluded.

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