Modern And Merck on Monday released further positive three-year data on its experimental vaccine, which was given to patients with the deadliest form of skin cancer in combination with the therapy Keytruda.
The vaccine in combination with Merck’s Keytruda improved survival and showed long-lasting efficacy in an interim study in patients with a deadly form of skin cancer. Moderna and Merck will present the data at the annual meeting of the American Society of Clinical Oncology in Chicago.
The vaccine is a key part of Moderna's product pipeline and has helped boost investor sentiment toward the biotechnology company after a bumpy last year that saw demand for its Covid vaccine, the only product currently commercially available, plummet.
The data includes the first results that the two companies announced in December.
According to new data, nearly 75% of patients who took the combination were alive after 2.5 years, with no signs or symptoms of their cancer returning, compared with just 55.6% of patients who received Keytruda alone.
This benefit was seen in different subgroups of patients, regardless of whether they had tumors with a large number of mutations or whether they had sufficient amounts of a protein called PD-L1, which helps keep the body's immune responses under control.
The data suggested the vaccine could help treat a “broad spectrum” of melanoma patients, said Dr. Kyle Holen, head of development, therapeutics and oncology at Moderna, in a press release.
The overall survival rate of patients who received the vaccine in combination with Keytruda was 96 percent after 2.5 years. By comparison, the survival rate for patients who received Keytruda alone was 90.2 percent.
“When we look at the three-year updates, I'm really excited about the consistency of these data,” Marjorie Green, head of global clinical development for oncology at Merck, said in an interview.
As the companies previously announced, patients with severe forms of melanoma who received the combination were 49 percent less likely to die or have their cancer return after about three years than patients who took Keytruda alone. The combination also reduced the risk of melanoma spreading to other parts of the body or dying by 62 percent.
The most common side effects of the vaccine, according to the data, were fatigue, pain at the injection site and chills. Most of these side effects were mild. Immune-related side effects were slightly more common in patients who received the combination.
The vaccine, which uses the same mRNA technology as Moderna's Covid vaccine, is tailored based on an analysis of a patient's tumors after surgical removal. The shot is designed to train the immune system to recognize and attack certain mutations in cancer cells.
Moderna is looking forward to shortening the time between initial tumor analysis and injection into the patient, CEO Stephane Bancel said in an interview with CNBC.
Merck's Keytruda is approved to treat melanoma and other cancers and is part of a group of widely used immunotherapies that aim to deactivate a specific protein that helps cancer evade the immune system.
The U.S. Food and Drug Administration granted breakthrough therapy designation to the cancer vaccine used to treat melanoma in February. This designation is intended to speed up the development and review of treatments for serious and life-threatening diseases.
But Moderna and Merck also want to apply to the FDA for an expedited approval process, Bancel noted. The process allows for accelerated approval of drugs for serious diseases that fill an unmet medical need.
According to the American Cancer Society, melanoma is responsible for the vast majority of deaths from skin cancer. The number of melanomas has increased dramatically in recent decades, according to the organization.
According to the American Cancer Society, about 100,000 people in the United States will be diagnosed with melanoma this year and nearly 8,000 people are expected to die from the disease.
The two pharmaceutical companies are studying the combination as a treatment for advanced melanoma in a Phase 3 trial that began in July. Bancel said the progress of that trial so far is “ahead of our plans.”
Merck is also conducting another Phase 3 study of the vaccine in patients with a certain type of lung cancer.
This year, Merck and Moderna began a two-part mid- to late-stage study of the vaccine and Keytruda in patients with advanced stages of a common skin cancer. The companies are also conducting a phase two study in certain patients with a certain type of kidney cancer and another study in people with a certain type of bladder cancer.
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