DR P. MARAZZI/SCIENCE PHOTO LIBRARY
A targeted treatment in patients with a specific type of lung cancer is likely to become the new standard of care after trial results showed “a highly clinically meaningful improvement” in outcomes for patients, researchers have said.
Results from the LAURA trial of osimertinib (Tagrisso; AstraZeneca) in patients with advanced non-small cell lung cancer, who could not be treated with surgery, showed a dramatic difference in progression-free survival.
Those who had been treated with the epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, following chemoradiotherapy, had an average of 39.1 months progression-free survival compared with 5.6 months in those who were given placebo — an 84% difference.
The trial, published in The New England Journal of Medicine on 2 June 2024, included 216 patients from 17 countries, who were randomly assigned to receive osimertinib (143 patients) or placebo (73 patients).
Presenting the results at the American Society for Clinical Oncology conference, held in Chicago on 31 May–4 June 2024, the researchers said that, after 12 months of treatment, the progression-free survival rate was 74% with osimertinib and 22% with placebo. By two years, the rates were 65% and 13%, respectively.
The benefit in progression-free survival was seen across subgroups, including age, sex, race, smoking history, stage of disease and EFGR mutation, researchers told delegates, who gave a standing ovation in response to the results.
Interim overall survival data showed 36-month overall survival among 84% of patients treated with osimertinib, and 74% in those treated with placebo, with a hazard ratio for death of 0.81.
No additional safety concerns were found, but half of patients on osimertinib interrupted treatment owing to an adverse event, and one in eight discontinued treatment, the results showed.
Overall, the incidence of adverse events of grade 3 or higher was 35% in the osimertinib group and 12% in the placebo group.
In the trial, the drug was given until disease progression, which could make it an expensive option, the researchers noted.
However, they said there was also some indication that the drug may be protective against the disease spreading to the central nervous system, with new brain lesions occuring in 8% of those on osimertinib, compared with 29% of patients taking placebo.
Study leader Suresh Ramalingham, a medical oncologist at the Emory Winship Cancer Institute in Atlanta, said: “Osimertinib demonstrated a statistically significant and highly clinically meaningful improvement in [progression-free survival]” and, alongside chemoradiotherapy, would “provide the new standard of care for EGFR-mutant disease in this setting”.
Commenting on the study, Charlie Swanton, chief clinician at Cancer Research UK (CRUK) and co-director of the CRUK Lung Cancer Centre of Excellence, said it was a “very significant result”.
“I don’t think I’ve ever seen such a small hazard ratio in a clinical trial.”
He added that osimertinib was a drug that this group of patients would be eligible for anyway, once they had progressed to metastatic disease, so the question now was whether to give it to patients sooner.
“The question in my mind is whether it is better getting it at this point than for first-line metastatic disease and the answer is probably yes,” he said.
