Stephanie Jojo, 27, stands for a portrait at a friend’s home in Penn Valley, Pennsylvania, Tuesday, May 9, 2017. Jojo, who was diagnosed with colon cancer at 22, has been in remission since February 2016. to an immunotherapy drug that targets specific mutations that prevents DNA replication errors from being corrected. The FDA is expected to make a decision on whether to approve Merck’s Keytruda by mid-May.
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Treatment with Merck’s antibody for patients with early-stage lung cancer who had previously had surgery to remove a tumor reduced the patient’s risk of recurrence or death by 24%, according to clinical trial data released Thursday.
Keytruda is a monoclonal antibody treatment that helps activate the body’s immune system to fight non-small cell lung cancer, the most common form of the disease. Injections of 200 milligrams are administered once every three weeks, for a total of 18 injections during the year.
Merck’s head of global clinical development, Dr. Roy Baines, described the reduction in the risk of cancer recurrence as significant and clinically relevant. Baines also expects Keytruda to improve overall patient survival, although he said the data is not yet mature enough to draw a definitive conclusion in this regard.
“When you treat a tumor at an early stage, it takes quite a long time for bad results to lead to death,” Baynes said. “Thus, at this point, the study is too immature to comment on overall survival, although we would say overall survival is currently favorable.”
In a clinical study of patients with early stage lung cancer after surgery, more than 1,000 people were randomized into two groups: 590 people who received treatment and 587 people who received placebo. Patients who received Keytruda were ill for an average of more than four years, which is about a year longer than those in the placebo group. The study included patients who received chemotherapy and those who did not.
Merck plans to submit data to the Food and Drug Administration as soon as possible, spokeswoman Melissa Moody said. Baines said the approval process could take eight to 12 months. Keytruda was first approved by the FDA in 2014 for melanoma and became a blockbuster drug for Merck, which is now being used to treat many other cancers.
Baynes said there has been significant progress in treating lung cancer with immune therapy. He noted that in the case of metastatic lung cancer, when the disease has spread to other parts of the body, Keytruda, in combination with chemotherapy, improved the five-year survival rate to 40%. Typically, the survival rate is only 5%.
According to the World Health Organization, lung cancer is the leading cause of cancer death worldwide, with more than 1.7 million people dying from it in 2020. People diagnosed with non-small cell lung cancer usually have surgery to remove the tumor if the disease is detected early. After surgery, patients are either monitored or receive chemotherapy. Risk factors include a history of smoking and exposure to asbestos.
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However, half of all patients with early-stage non-small cell lung cancer return within five years of tumor removal, and in most of them, the cancer returns after two years, according to Dr. Mary O’Brien, co-author. Principal Litigation Investigator and Oncologist at the Royal Marsden Hospital in London. According to her, patients live in constant fear and anxiety that the cancer will return.
Keytruda prevents cancer cells from turning off the body’s defense system. Cancer cells have a protein that binds to a receptor on T cells, which causes them not to attack. Instead, the Keytruda monoclonal antibody binds to this receptor, thwarting the cancer’s trick and allowing the immune system to fight the disease.
Baynes said the drug is generally well tolerated, although there are side effects associated with turning on the immune system. The most common complication is thyroid toxicity, which occurs when the thyroid gland releases too much of the hormone into the body. In more serious but rare cases, patients can develop pneumonitis, an inflammation of the lung tissue, he said. Thyroid toxicity is treated with antithyroid drugs and pneumonitis with steroids.
Merck Keytruda’s 2021 sales were $17.2 billion, or about 35% of the company’s total yearly revenue of $48.7 billion. CEO Rob Davies told investors in Merck’s fourth-quarter earnings report that using Keytruda to prevent cancer recurrence in patients is a key area for the company’s future growth.
While cancer immune therapy is a major area of clinical research, the FDA has so far only approved one treatment to prevent the return of lung cancer in patients who have had surgery. The agency approved Genentech’s Tecentriq last October.