Moderna And Merck On Monday, it released more positive three-year data on its experimental vaccine, which has been given to patients with the deadliest forms of skin cancer in combination with the treatment Keytruda.
The vaccine with Merck's Keytruda improved survival and showed long-lasting efficacy in a mid-stage study in patients with a deadly form of skin cancer. Moderna and Merck are presenting the data at the American Society of Clinical Oncology's annual meeting in Chicago.
The shot is a key part of Moderna's pipeline that has helped support investor sentiment for the biotech company after a difficult last year, when demand for its Covid vaccine, its only commercially available product at the moment, fell.
The data includes preliminary results announced by the two companies in December.
Among the new data, nearly 75% of patients who took this combination were alive without any signs or symptoms indicating the cancer had returned after two and a half years. This compares to 55.6% of patients who took Keytruda alone.
This benefit has been seen in different subgroups of patients, regardless of whether they have tumors with a large number of mutations or whether they have enough of a protein — called PD-L1 — that helps keep the body's immune responses in check.
The data reflects the potential for the shot to help treat a “broad range” of melanoma patients, Dr. Kyle Hollen, Moderna's head of development, therapeutics and oncology, said in a statement.
The overall survival rate for patients who received the vaccine with Keytruda was 96% after two and a half years. This compares to 90.2% among those who took Keytruda alone.
“As we look at the triennial updates, what's really exciting for me is seeing the robustness of that data,” Marjorie Green, Merck's head of global clinical development for oncology, said in an interview.
As the companies previously announced, patients with severe forms of cancer, known as melanoma, who received the combination were 49% less likely to die or have their cancer return than those who took Keytruda alone after about three years. This combination also reduced the risk of skin cancer spreading to other parts of the body, or death, by 62%.
The most common side effects associated with the vaccine were fatigue, pain at the injection site and chills, according to the data. The majority of these side effects were mild. Patients who received this combination had slightly higher immune-related side effects.
The vaccine, which uses the same mRNA technology used in Moderna's Covid vaccine, is specifically designed based on analysis of a patient's tumors after surgical resection. The shot is designed to train the immune system to recognize and attack certain mutations in cancer cells.
Moderna is excited to work to reduce the time between the initial analysis of a tumor and the time a patient is given the injection, Moderna CEO Stephane Bancel said in an interview with CNBC.
Meanwhile, Merck's Keytruda, which is approved to treat melanoma and other cancers, belongs to a class of widely used immunotherapies designed to disable a specific protein that helps cancer escape the immune system.
Last February, the US Food and Drug Administration granted breakthrough therapeutic designation to the cancer vaccine to treat skin cancer. This classification aims to accelerate the development and review of treatments for serious and life-threatening diseases.
But Bancel noted that Moderna and Merck also plan to apply for accelerated approval from the US Food and Drug Administration. This process allows for rapid approvals of drugs for serious conditions that address unmet medical needs.
Melanoma is responsible for the vast majority of skin cancer deaths, according to the American Cancer Society. The incidence of melanoma has risen rapidly over the past few decades, according to the organization.
About 100,000 people will be diagnosed with melanoma in the United States this year, and nearly 8,000 people are expected to die from the disease, according to the American Cancer Society.
The two drug companies are studying the combination as a treatment for late-stage melanoma in a phase 3 trial, which began in July. Bancel said progress in that trial is “ahead of our plans” so far.
Merck is also conducting another Phase 3 trial of the vaccine in patients with a type of lung cancer.
This year, Merck and Moderna began a two-part mid- and late-stage trial of the vaccine and Keytruda in patients with advanced-stage common melanoma. The companies are also conducting a phase 2 trial in some patients with a type of kidney cancer, and another study in people with a type of bladder cancer.
