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An experimental, personalized cancer vaccine, developing Merck and Moderna, recorded positive initial results in the first large-scale final-stage study, the two companies announced on Wednesday, bringing it under development treatment one step closer to applying for approval.
The mRNA technology vaccine, in combination with Immunotherapy Keytruda Merck's hit them key phase 3 study objectives, in which more than 1,100 patients with high risk or advanced melanoma. In these patients the detectable cancer was completely removed by surgery.
Merck's share was strengthened more than 8% President-in-Office of the Council. Moderna's share has been found to be stronger than 137%. The big difference in changes significantly reflects the different size of the two companies: Merck's stock value was before the start of trade at around $333 billion, compared to about $25 billion for Moderna.
The combination of the two treatments achieved the main objective of the study, significantly prolonging the period during which patients remained without recurrence of melanoma, compared to the administration of Keytruda alone. At the same time, it reduced the risk of cancer spreading to remote sites of the organism.
The results come to strengthen the positive data from the phase 2 study of the same therapeutic combination, which had been announced earlier this year.
"It's a Big time for medicine and a great time for patients," said Moderna CEO, Stefan Bansel, in an interview with CNBC. Phase 3 will continue, in order to evaluate other parameters, including whether the combination improves the overall survival of patients.
The two pharmaceutical companies plan to present the detailed data at a forthcoming international medical conference, but have not specified when they will submit applications for US treatment approval.
Treatment led to "clinically significant improvement"
Companies are expected to start discussions with regulators over the next few months about her treatment and safety profile, Dr. Dean Lee, president of Merck Research Laboratories, told CNBC.
The initial results show that this combination could constitute a new therapeutic option for melanoma. Although it corresponds to approximately 1% of skin cancer cases, melanoma is responsible for the large majority of deaths from this category of cancer. Most recurrences of melanoma occur within the first two to three years after initial treatment and removal of the tumor.
"Thewith melanoma are called upon to manage the weight of such a diagnosis and then undergo difficult treatments such as surgery. And after all this, they live in fear that cancer will return," said Dr. Jane Healy, head of Merck's early development department of oncology treatments.
She described the fact that treatment led to "clinically significant improvement" compared to Keytruda, which is standard treatment for melanoma, while well tolerated by patients. Adverse reactions were similar to those usually seen in other vaccines, he noted.
