modern and Merck on Monday released more positive three-year data on their experimental vaccine, which is used in combination with Keytruda therapy to treat patients with the deadliest form of skin cancer.
The vaccine, along with Merck & Co.’s Keytruda, improves survival and shows long-lasting efficacy In a mid-stage study of patients with fatal skin cancer. Moderna and Merck presented the data at conference American Society of Clinical Oncology The annual meeting is held in Chicago.
The vaccine is a key part of Moderna’s pipeline, helping to boost investor confidence in the biotech after a rough patch last year when the release of its COVID-19 vaccine, currently the company’s only commercial product, Demand dropped significantly.
The data includes preliminary results reported by both companies in December.
New data shows that nearly 75% of patients who took the combination were alive after 2.5 years without any signs or symptoms of cancer recurrence. This compares with 55.6% of patients who received Keytruda alone.
The 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 to help control the body’s immune response.
Dr. Kyle Holen, Moderna’s head of development, therapeutics and oncology, said in a news release that the data reflect the vaccine’s potential to help treat a “broad range” of melanoma patients.
Patients who received this vaccine combined with Keytruda had an overall survival rate of 96% after 2.5 years. That compares with 90.2 percent of people taking Keytruda alone.
As the companies previously announced, patients with severe cancers known as melanoma who received the combination were 49% less likely to die or have their cancer return after about three years than those who took Keytruda alone. The combination also reduced the risk of melanoma spreading to other parts of the body or dying by 62%.
Data shows the most common side effects associated with the vaccine are fatigue, injection site pain and chills. Most side effects are mild. Immune-related side effects were slightly higher in patients who received the combination therapy.
The vaccine uses the same mRNA technology as Moderna’s Covid vaccine and is tailored based on analysis of patients’ tumors after surgical removal. This injection is designed to train the immune system to recognize and attack specific mutations in cancer cells.
Moderna CEO Stephane Bancel said in an interview with CNBC that he is excited about shortening the time between initial analysis of tumors and patient injection.
Meanwhile, Merck’s Keytruda, approved to treat melanoma and other cancers, belongs to a widely used class of immunotherapies designed to disable a certain protein that helps cancer evade the immune system.
Released by the U.S. Food and Drug Administration in February Breakthrough therapy designation Cancer vaccines to treat melanoma. This designation is intended to expedite the development and review of treatments for serious and life-threatening diseases.
But Bancel pointed out that Moderna also plans to apply for accelerated approval from the FDA. This process expedites approval of drugs to treat serious diseases and address unmet medical needs.
According to the American Cancer Society, melanoma is responsible for most skin cancer deaths. According to the organization, the incidence of melanoma has increased rapidly over the past few decades.
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.
Two drug companies are studying the combination as a treatment for advanced melanoma Phase III trial, starting in July. Bancel said the trial has progressed “exceeding our plans” so far.
Moderna 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- to late-stage trial of the vaccine and Keytruda in patients with advanced forms of a common skin cancer. The companies are also conducting a Phase 2 trial in some patients with a type of kidney cancer and another study in patients with a type of bladder cancer.
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