This announcement brought both the companies one step closer to file for an approval from the US drug regulator to approve this as a treatment option.
The vaccine was a mRNA-based shot in combination with Merck’s immunotherapy drug Keytruda, and it met key goals in the Phase 3 trial, which was carried out in more than 1,100 patients with higher-risk or advanced melanoma, whose detectable cancer had been completely removed through surgery.
Melanoma is one of the deadliest forms of skin cancer as at least 1.12 lakh people in the US are diagnosed with it every year and nearly 8,500 die from it, according to data from the American Cancer Society. Although it accounts for only 1% of the total skin cancers, but majority of the deaths occur due to this. Most recurrences also develop in the first two to three years after the initial treatment and removal.
Shares of Merck & Co. also climbed 13% on Wednesday on the news.
The main study goal of this combination regimen was to significantly extend the life of patients without their Melanoma returning, in comparison to the use of only Keytruda. That goal was achieved. Not just that, the treatment also reportedly reduced the risk of the cancer spreading to other distant parts of the body.
Moderna CEO Stephane Bancel called this a “big moment for medicine, a big moment for patients,” in an interview to CNBC.Further outcomes will also be studied under Phase 3, including the overall survival benefit. Both companies will present this data at an upcoming international medical meeting, although they have not specified a timeline as to when they will submit an application to the regulators for approval in the US. Officials from Merck told CNBC that this will be done “in the next few months.”
The vaccine is also being tested for other tumors, such as non-small cell lung cancer, bladder cancer, and renal cell carcinoma.
