Certain early-stage lung cancer patients who take the drug Tagrisso (osimertinib) after surgery may dramatically boost their survival odds, new study results suggest.
The trial included 682 patients with non-small-cell lung cancer (NSCLC), the most common type of lung cancer, whose tumors had mutations in the epidermal growth factor receptor (EGFR) gene. This gene can cause rapid cell growth and help cancer spread more quickly.
All patients all underwent cancer surgery, then were randomly assigned to take a daily pill with either a placebo or an 80 milligram (mg) dose of Tagrisso, a targeted therapy that’s designed to treat tumors with mutated EGFR genes.
After three years, the patients who took Tagrisso had a 51 percent lower risk of death from early-stage lung cancer, according to study results published June 4 in the New England Journal of Medicine and presented at the annual meeting of the American Society of Clinical Oncology.
The five-year overall survival rate was 88 percent for patients who received Tagrisso, compared with 78 percent on a placebo. There were too few deaths in the study to determine exactly how long the survival benefit might ultimately extend.
While Tagrisso is already FDA-approved for the patients who took it in the study, the results offer fresh evidence that the drug can work even for patients with smaller, less advanced tumors, said Roy S. Herbst, MD, PhD, the principal investigator on the study and the deputy director of the Yale Cancer Center in New Haven, Connecticut, in a statement.
“The results are impressive,” Dr. Herbst said. “We’re moving this effective drug therapy into the earliest stages of disease.”
Study Confirms Benefit for Early-Stage Lung Cancer Patients
Tagrisso was first approved in 2018 as an initial treatment for patients with advanced lung cancer whose tumors had EGFR mutations. The U.S. Food and Drug Administration (FDA) expanded the approval in 2020, clearing the drug for use as an adjuvant, or follow-up, therapy for earlier-stage lung cancer patients with EGFR mutations.
“With this approval, patients may be treated with this targeted therapy in an earlier and potentially more curative stage of non-small-cell lung cancer,” said Richard Pazdur, MD, the director of the FDA’s Oncology Center of Excellence and the acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research, in a 2020 statement announcing the expanded approval.
The new 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,” says Susan Scott, MD, an assistant professor of oncology at Johns Hopkins School of Medicine in Baltimore who wasn’t involved in the research.
Oncologists Should Take Note
Beyond this, the findings may also encourage any oncologists who were on the fence about using Tagrisso for early-stage tumors to move in this direction, says Nathan Pennell, MD, PhD, a professor and the director of the lung cancer medical oncology program at the Cleveland Clinic Taussig Cancer Institute in Ohio.
That’s because the FDA-approval of Tagrisso for early-stage lung cancer patients wasn’t based on overall survival rates. It was based instead on what’s known as disease-free survival (DFS), or how long patients live without cancer coming back after initial treatment. Tagrisso reduced cancer recurrence by 80 percent in data reviewed by the FDA to approve the drug for early-stage lung cancer.
“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,” says Dr. Pennell, who wasn’t involved in the new research. “But there were some who waited for the overall survival results, and this should change their practice.”
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