Lung Cancer Pill Cuts Risk of Death by Half
A new lung cancer pill taken once a day has the potential to cut the risk of death by more than half, according to a global study that researchers and medical professionals called, “thrilling” and a potential game-changer in the treatment of lung cancer.
The study showed that osimertinib, when combined with standard chemotherapy and taken after surgery, significantly improved the survival rates of patients with advanced non-small cell lung cancer.
“Thirty years ago, there was nothing we could do for these patients,” Dr. Roy S. Herbst, lead author and principal investigator of the ADAURA trial, said in a news statement. ”Fifty percent is a big deal in any disease, but certainly in a disease like lung cancer, which has typically been very resistant to therapies.”
Lung cancer is the world’s leading cause of cancer death, accounting for an estimated 1.8 million deaths a year, according to the Global Cancer Statistics of 2020. In the United States, lung cancer is the leading cause of cancer death, accounting for about 1 in 5 of all cancer deaths, according to the American Cancer Society (ACS). The ACS further reports that lung cancer (both small-cell and non-small cell lung cancer) is the second most common cancer in both men and women (not counting skin cancer). Most people diagnosed with cancer are 65 years old and older, with the average age of diagnosis being 70, the ACS says.
Chemotherapy, surgery, and radiation therapy are traditional forms of treating lung cancer. But the disease can also be treated with targeted therapy drugs, like osimertinib,
The ADAURA trial, led by researchers at Yale University, involved 682 patients in 26 countries with non-small cell lung cancer. The patients were between the ages of 30 and 86 years old and all had a mutation of the Epidermal Growth Factor Receptor (EGFR) gene. EGFR is a protein most commonly found on skin cells. A mutation of the EGFR gene can cause rapid cell growth and help cancer spread more quickly. In addition, about two-thirds of the patients were women and about two-thirds of patients did not have a history of smoking. Researchers suggested the pill works for smokers and non-smokers diagnosed with lung cancer.
The patients were randomly assigned to take a daily pill with either an 80 milligram dose of osimertinib or a placebo. After three years, patients who took osimertinib had a 51 percent lower risk of death from early-stage lung cancer. And, after five years, patients who took osimertinib after their tumor was removed had an 88 percent survival rate, compared with 78 percent of patients who took the placebo.
According to the study, there were too few deaths to determine exactly how long the survival benefit might ultimately extend. Researchers said the survival benefit “was observed consistently” in an analysis across all study subgroups, including patients with stage one, stage two and stage three lung cancer. Chemotherapy had been given to 60 percent of patients in the study, and the survival benefit of osimertinib was seen whether or not patients had chemotherapy.
The study was published June 4 in the New England Journal of Medicine, and Dr. Herbst presented the results at the American Society of Clinical Oncology’s annual meeting in Chicago in June. Dr. Herbst said the “thrilling” results “added huge weight to earlier findings from the same trial that showed the pill also halves the risk of a recurrence of the disease,” The Guardian reported.
Lung Cancer Pill Has FDA Approval
Osimertinib was approved in 2018 by the U.S. Food and Drug Administration (FDA) as an initial or “first-line” treatment for people with advanced non-small cell lung cancer that has specific EGFR mutations. Osimertinib is sold under the brand name, Tagrisso, and manufactured by AstraZeneca.
According to Dr. Herbst, who is also the deputy director of Yale Cancer Center, 10-15 percent of U.S. lung cancer patients will have EGFR mutations; and even though they receive the best available therapy, their tumor often comes back.
“We’re now adding osimertinib, a pill that targets this specific receptor, and what we’ve found is a significant overall survival benefit for patients who received osimertinibm,” Herbst said.
Dr. Susan Scott, an assistant professor of oncology at Johns Hopkins School of Medicine in Baltimore who wasn’t involved in the research, told Everyday Health, that the study results “confirm that adjuvant Tagrisso should remain standard of care for patients with EGFR-driven lung cancer at high risk of recurrence after surgery.”
In 2020, the FDA expanded osimertinib’s approval, clearing the pill’s use as an adjuvant, or follow-up, therapy for earlier stage lung cancer patients with EGFR mutations. Before expanding its approval, the FDA reviewed results from osimertinib’s randomized trial, which measured outcome based on what’s called, “disease-free survival,” (DFS) which meant how long patients live without cancer coming back after the initial treatment. The trial showed that osimertinib reduced cancer recurrence by 80 percent compared with patients who received a placebo.
The trial’s findings could potentially change the minds of oncologists who were not sure whether to use osimertinib for early-stage tumors, said Dr. Nathan Pennell, a professor and the director of the lung cancer medical oncology program at the Cleveland Clinic Taussig Cancer Institute in Ohio, who was not involved in the trial.
“For many oncologists in the U.S. this will simply affirm what they were already doing in offering adjuvant Tagrisso based on the prior DFS benefit,” Dr. Pennell told Everyday Health. “But there were some who waited for the overall survival results, and this should change their practice.”
Oncologists may also be interested in knowing that osimertinib can work in stopping the spread of lung cancer.
“When we treat the cancer early, we prevent the cancer from spreading to the brain, to the liver, to the bones,” Dr. Herbst said in a statement. “In this trial, we took advantage of the efficacy of osimertinib, used it earlier, and it resulted in a really phenomenal impact on survival. That’s practice-changing, and it helps people live longer with lung cancer. I’m very excited to be part of this research.”