Although research has shown that the administration vaccine against skin cancer It has positive results, the treatment failed to overcome the “bar” required to release to the general public.
The experimental vaccine For skin cancer, in combination with already approved Merck Keytruda Immunotherapymanaged to significantly delay the progression of the disease with patients who have advanced melanoma.
His information Reuters, however which is required for the results to be sufficiently considered “unmistakable” for immediate approval.
What did the studies show
The study showed that patients who took the CYLEMBIO – KEYTRUDA combination They lived on average 19.4 months without deteriorating the diseasefor 11 months for those who only got Keytruda.
The difference is great in practice, but scientists use strict statistical boundaries to make sure a result is not accidental. In the case of IO Biotech, the result was so marginal that it did not cross the official “threshold” of credibility, leaving scientists a “window” of doubt.
“It was a very marginal failure, almost in chuck,” said Managing Director Mai-Britt Zocca.
Subsequent steps
The company issued a statement that the combination of the two treatments was well tolerated by patients and did not cause new security problems.
Even existed Trend of improvement and in the overall survival of patients.
In the autumn, the company’s scientists will meet with US Food and Drug Administration (FDA) to discuss if they can deposit Applicationeither for all patients or for specific subgroups.
HC Wainwright analyst estimated that there is still a possibility of approval, especially if the FDA accepts the application for selected patients or if the most mature survival elements expected in 2026 confirm the benefit.
According to 2022 figures, about 1.5 million people live in the US. Today the treatments include Bristol Myers Keytruda and Opdivo, while Moderna is also testing the melanoma vaccine in combination with Keytruda.
Source: iatropedia.gr