modern and merck On Monday it released more positive three years of data on its experimental vaccine, given to patients with the deadliest form of skin cancer in combination with the Keytruda therapy.
Vaccine along with Merck's Keytruda improved survival and showed long-lasting efficacy in a mid-stage study in patients with a fatal form of skin cancer. Moderna and Merck will present the data at the American Society of Clinical Oncology annual meeting in Chicago.
The vaccine is a key part of Moderna's portfolio that has helped shore up investor sentiment toward the biotech company after a difficult last year, when demand plummeted for its Covid vaccine, for now its only commercially available product.
The data includes initial results that the two companies announced in December.
Among the new data, nearly 75% of patients taking the combination were alive without any signs or symptoms of the cancer returning after two and a half years. That compares to 55.6% of patients who received Keytruda alone.
That benefit was seen in different subgroups of patients, regardless of whether they had tumors with a large number of mutations or whether they had enough of a protein, called PD-L1, that helps keep the body's immune responses in check.
The data reflects the shot's potential to help treat a “broad range” of melanoma patients, Dr. Kyle Holen, Moderna's head of development, therapeutics and oncology, said in a statement.
The overall survival rate for patients who received the vaccine in combination with Keytruda was 96% after two and a half years. That compares to 90.2% among those who took Keytruda alone.
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. The combination also reduced the risk of melanoma spreading to other parts of the body or death by 62%.
According to the data, the most common side effects associated with the vaccine were fatigue, pain at the injection site and chills. Most of those side effects were mild. Patients who received the combination had slightly higher immune-related side effects.
The vaccine, which uses the same mRNA technology as Moderna's Covid vaccine, is custom-made based on an analysis of a patient's tumors after their surgical removal. The injection is designed to train the immune system to recognize and attack specific mutations in cancer cells.
Moderna is excited to work to reduce the time between the initial analysis of a tumor and the time the injection is given to the patient, CEO Stéphane 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 certain protein that helps cancer evade the immune system.
In February, the U.S. Food and Drug Administration granted breakthrough therapy designation to the cancer vaccine for the treatment of melanoma. That designation is intended to accelerate the development and review of treatments for serious and life-threatening diseases.
But Moderna also plans to apply for accelerated approval with the FDA, Bancel said. The process allows for accelerated approvals of drugs for serious conditions that meet an unmet medical need.
Melanoma is responsible for the vast majority of skin cancer deaths, according to the American Cancer Society. According to the organization, the rate of melanoma has increased rapidly in recent decades.
According to the American Cancer Society, about 100,000 people will be diagnosed with melanoma in the U.S. this year and nearly 8,000 people are expected to die from the disease.
The two drugmakers are studying the combination as a treatment for late-stage melanoma in a phase three trial, which began in July. Bancel said progress on that trial is “ahead of our plans” so far.
Moderna is also conducting another phase three trial of the vaccine in patients with a type of lung cancer.
This year, Merck and Moderna began a two-part, mid- to late-stage trial of the vaccine and Keytruda in patients with an advanced stage of a common skin cancer. The companies are also conducting a phase two trial in certain patients with a type of kidney cancer and another study in people with a type of bladder cancer.
