Newfangled AND Merck released more positive data for three years On Monday, about their experimental vaccine, administered to patients with the deadliest form of skin cancer, in combination with Keytruda therapy.
The vaccine, when combined with Merck’s Keytruda, improved survival and demonstrated long-term effectiveness in an interim study in patients with terminal skin cancer. Moderna and Merck present data at the conference American Society of Clinical Oncology annual meeting in Chicago.
The shot is a key part of Moderna’s plan that has helped strengthen investor sentiment toward the biotech company after a hard last year when demand for its Covid vaccine, currently the only product available on the market, plummeted.
The data includes preliminary results that both companies announced in December.
Novel data shows that almost 75% of patients who took this drug combination survived without any signs or symptoms of cancer returning after 2.5 years. In comparison, the proportion of patients who received Keytruda alone was 55.6%.
This benefit was seen in different subgroups of patients, whether they had tumors with a high number of mutations or whether they had enough of a protein – called PD-L1 – that helps control the body’s immune response.
The data reflects the shot’s potential to support treat a “broad subset” of melanoma patients, Dr. Kyle Holen, Moderna’s chief development, therapeutics and oncology officer, said in the release.
The overall survival rate for patients who received the vaccine in combination with Keytruda was 96% after 2.5 years. This compares to 90.2% among people taking Keytruda alone.
“When we look at three-year updates, what really excites me is the durability of this data,” Marjorie Green, director of global oncology clinical development at Merck, said in an interview.
As the companies previously announced, patients with a severe form of cancer known as melanoma who received this drug combination were 49% less likely to die or have their cancer come back compared with patients 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%.
The data showed that the most common side effects associated with the vaccine were fatigue, pain at the injection site and chills. Most of these side effects were soft. Patients who received this combination experienced slightly more immune-related side effects.
The vaccine, which uses the same mRNA technology as Moderna’s Covid vaccine, is being custom-developed based on analysis of a patient’s tumors after surgical removal. The injection is designed to train the immune system to recognize and attack specific mutations in cancer cells.
Moderna is excited about working to shorten the time between initial tumor analysis and a patient being injected, CEO Stephane Bancel said in an interview with CNBC.
Meanwhile, Merck’s Keytruda, approved for the treatment of melanoma and other cancers, is in a class of widely used immunotherapies that aim to disable a specific protein that helps cancer evade the immune system.
In February, the US Food and Drug Administration reported breakthrough therapy designation for a cancer vaccine to treat melanoma. This designation aims to accelerate the development and review of treatments for sedate and life-threatening diseases.
But Moderna and Merck also plan to apply to the FDA for accelerated approval, Bancel noted. This process allows for accelerated approval of drugs for sedate conditions that address unmet medical needs.
According to the American Cancer Society, melanoma is responsible for the immense majority of skin cancer deaths. According to the organization, the incidence of melanoma has increased dramatically over the past few decades.
According to the American Cancer Society, approximately 100,000 people in the U.S. will be diagnosed with melanoma this year, and it is estimated that nearly 8,000 people will die from the disease.
Both drugmakers are investigating this drug combination for the treatment of late-stage melanoma in: phase three trial, which started in July. Bancel said progress in the trial is “exceeding our previous plans.”
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 two-part mid- and late-term studies of the vaccine and Keytruda in patients with advanced stages of a common skin cancer. The companies are also conducting a phase 2 study in some patients with a type of kidney cancer and another study in people with a type of bladder cancer.
