Tagrisso (osimertinib) was more effective than chemotherapy in treating lung cancer patients whose disease had progressed on another treatment, according to a Phase 3 clinical trial.
Patients who took Tagrisso also had significantly better progression-free survival rates than a placebo group, and few side effects, the AstraZeneca-sponsored trial showed.
The study, “Patient-reported symptoms and impact of treatment with osimertinib vs chemotherapy for advanced non-small-cell lung cancer,” was presented at the European Lung Cancer Conference 2017 in Geneva, May 5–8.
“With my past experience conducting clinical trials, I often see new treatments that might be more effective, but are also usually more toxic,” Dr. Chee Lee, the study’s lead author, said in a press release. He is an oncologist at the St. George Hospital Cancer Care Centre in Australia.
“Osimertinib not only increases progression-free survival, but it is well-tolerated, which makes a big difference for our patients,” he said.
The Phase 3 AURA3 trial (NCT02151981) covered 419 patients with advanced non-small cell lung cancer and an epidermal growth factor receptor (EGFR) mutation called T790M.
Tumors with the receptor become resistant to the EGFR-tyrosine kinase inhibitors that patients took before the trial. That led to the patients’ cancer progressing. Because Tagrisso is a newer-generation EGFR-tyrosine kinase inhibitor, researchers thought it might be effective against lung cancer — and it proved to be.
Patients were randomly split into groups receiving a Tagrisso tablet or chemotherapy. Those receiving Tagrisso had a progression-free survival rate of 10.1 months. Chemotherapy, on the other hand, put off the disease for only 4.4 months.
Tagrisso users said they experienced fewer lung cancer symptoms as well. The main ones, they said, were breathlessness, chest pain, fatigue and loss of appetite. “It generally took longer for these symptoms to get worse in patients taking the osimertinib tablet compared to chemotherapy,” Lee said.
In addition, patients said Tagrisso improved their physical, cognitive, emotional and social functioning. “Patients taking osimertinib were more able to do normal daily activities and socialize than those on chemotherapy,” Lee said.
“Patients with metastatic lung cancer receiving first-line treatment are really quite sick,” he said. “Patients in the AURA3 trial had progressed on first-line treatment and were receiving second-line therapy, so they were even sicker. To be able to reduce cancer symptoms and improve quality of life in addition to progression-free survival for these patients is a major leap.
“For patients with incurable cancer, prolonging only progression-free survival probably has very little meaning for them,” he added. “However, treatment that can additionally improve symptoms and maintain quality of life probably means a lot for these patients.”
Dr. Solange Peters, head of oncology at University Hospital Center of Vaudois in Switzerland, said the results indicated that the patients in the trial should stay with a newer-generation tyrosine kinase inhibitor.
“Before these results, clinicians had the feeling that second-line osimertinib would be efficient and better tolerated than chemotherapy ,but it was a subjective assumption,” she said. “We now have proof that the drug has better activity, less toxicity, and improves quality of life.”
Peters said she hopes to see research on other treatment-resistant therapies. “More research is needed to find better second-line treatments for patients with a different mechanism of resistance, for whom chemotherapy is currently the only option,” she said.