MerckClinical trial data from Thursday showed that patients with early-stage lung cancer who had previously received surgery to remove tumors, were 24% less likely to die or have their disease return.

Keytruda (a monoclonal antibody therapy) is designed to help activate the body’s immune systems in order to combat non-small-cell lung cancer. Each 200-milligram shot is administered three times a week for 18 total injections in a single year.

The Merck head of global clinical developments, Dr. Roy Baynes described the decreased risk of cancer returning as clinically significant. Baynes expects Keytruda will improve the overall survival rate of patients, but he stated that data are not yet sufficient to make a conclusive conclusion.

Baynes explained that even if a tumor is treated early enough, bad outcomes can be very difficult to reverse into death. Baynes stated that although the trial was too early to make any comment about overall survival, the direction of survival seems favorable.

More than 1,000 patients with early-stage lung cancer were evaluated in a clinical trial. They were randomly divided into 2 groups. 590 of them received treatment, and 587 got a placebo. Keytruda patients had a median of four years with disease, which is about one year more than the placebo group. Patients who had received chemotherapy were included in the trial, as well as those who didn’t.

Melissa Moody spoke on behalf of Merck, saying that the company plans to quickly submit the data to FDA. Baynes says that approval can take anywhere from eight to twelve months. Baynes states that Keytruda was initially approved by FDA to treat melanomas in 2014. It has since become a major blockbuster for Merck, and can be used to treat other forms of cancer.

Baynes noted that lung cancer treatment with immunotherapy has made significant improvements. Baynes noted that metastatic lung cancer has progressed to other parts of the body and Keytruda, in conjunction with chemotherapy, has increased the 5-year survival rate by 40%. In general, survival rates are only 5%.

According to the World Health Organization, lung cancer was the most common cause of death from cancer in the world. More than 1.7million people will die due to it by 2020. If the cancer is detected in its early stages, patients with non-small-cell lung cancer usually have surgery. The patient can choose to have chemotherapy or be observed after the surgery. A history of asbestos and smoking are risk factors.

Half of those with non-small cell lung carcinomas in their early stages have it return within five years. Most patients see it return within two years. Dr. Mary O’Brien is a co-principal Investigator in this trial. She’s an oncologist at Royal Marsden Hospital. According to Dr. Mary O’Brien, patients are constantly afraid and anxious that their cancer will come back.

Keytruda is a drug that stops cancer cells closing down the body’s defense system. The protein in cancer cells binds with a T cell receptor, tricking them into not attacking. Instead, the Keytruda monoclonal antibodies binds with this receptor and foils the trick of cancer cells. This allows the immune system to combat the disease.

Baynes indicated that while the drug can generally be tolerated well, there may be side effects from the immune system going into overdrive. Thyroid toxicity is the most serious side effect. This happens when too many hormones are released into the body. Patients can also develop pneumonitis (inflammation of the lung tissue), in more severe cases. The treatment of thyroid toxicities is antithyroid medication, and the steroids for pneumonitis are both used.

Merck’s Keytruda sales accounted for 35% of its $48.7billion total revenue in 2021. Merck CEO Rob Davis informed investors at the fourth-quarter Merck earnings call that Keytruda prevents patients from getting cancer again is a key area for future growth.

The FDA approved one treatment for lung cancer prevention in the past to keep it from returning. This is the only approval that has been granted so far by the FDA. Genentech’s Tecentriq received approval from the FDA in October.