AstraZeneca PLC's Tagrisso cut the risk of disease progression or death by more than half in adult patients with locally advanced or EGFR-mutated nonsmall cell lung cancer, raising the prospect of a new standard of care in the first-line treatment of the disease, according to data presented at the European Society for Medical Oncology, or ESMO, 2017 Congress.

Results from the phase 3 Flaura trial showed a clinically meaningful progression-free survival advantage of 18.9 months compared with 10.2 months for the current standard of care. They also showed a low rate of adverse events, the most prevalent being diarrhea and dry skin.

"The Flaura data are truly exciting," said Sean Bohen, AstraZeneca's chief medical officer and executive vice president of global medicines development. "The Flaura data suggest early and sustained benefit with Tagrisso that has the potential to significantly impact long-term patient outcomes and help address the considerable unmet need that remains."

Analysts including Leerink's Seamus Fernandez had been looking for the Flaura trial to replicate the 19-month progression-free survival benefit Tagrisso attained in its Phase I trial. This "should be enough to drive (first-line) use of the agent over first and second generation EGFR inhibitors," he wrote ahead of ESMO.

Tagrisso is currently approved in 50 countries as a second-line treatment for patients with advanced NSCLC who progress following treatment. AstraZeneca is set to launch at least six new medicines in its fast-growing oncology portfolio before 2020, and is in discussions with global regulators about submitting this latest Flaura data for review.

"The Flaura data are likely to result in a major paradigm shift in the treatment of patients with EGFR mutation-positive advanced lung cancer," said Suresh S. Ramalingam, principal investigator of the Flaura trial, from the Winship Cancer Institute of Emory University in Atlanta. "Not only did the trial demonstrate a robust improvement in efficacy, the side effects profile was also more favorable."