Late-stage data show that AstraZeneca's Tagrisso extended the time lung cancer patients carrying a particular mutation lived without their disease worsening, potentially signalling a new standard of care in the second-line setting.
The first randomised Phase III trial (AURA3) pitting Tagrisso (osimertinib) against chemotherapy showed that the drug extended progression-free survival (PFS) by 5.7 months in patients with epidermal growth factor receptor (EGFR) T790M mutation-positive locally-advanced or metastatic non-small cell lung cancer (NSCLC), with data showing PFS of 10.1 months versus 4.4 months.
Also, in the 34 percent of patients with central nervous system (CNS) metastases at baseline, PFS was significantly greater with Tagrisso than chemotherapy at 8.5 months versus 4.2 months, AZ noted.
Overall, Tagrisso was shown to reduce the risk of disease progression by 70 percent compared with standard platinum-based doublet chemotherapy.
"The confirmatory Phase III data suggest the potential for Tagrisso to replace chemotherapy as the standard of care for patients who have progressed following EGFR tyrosine kinase inhibitor treatment," noted Sean Bohen, AZ' chief medical officer.
"As lung cancer is the most common type of cancer to spread to the brain, it is also encouraging to see the activity of Tagrisso in patients with central nervous system metastases whose prognosis is often particularly poor."
Dr Vassiliki A Papadimitrakopoulou, from the University of Texas MD Anderson Cancer Center, said the results of AURA3 "are not only statistically significant, but clinically meaningful because it is the first time a targeted medicine like Tagrisso has shown improvement in progression-free survival over standard platinum-pemetrexed chemotherapy. It's very rewarding to be able to give this type of news to patients, as it highlights the major advances we are making in targeted lung cancer treatments."
Tagrisso was granted accelerated approval by the US Food and Drug Administration in November 2015 for the treatment of patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, who have progressed on or after EGFR TKI therapy.
In the EU, Tagrisso was granted conditional marketing authorisation for adult patients with locally advanced or metastatic EGFR T790M NSCLC, irrespective of previous EGFR-TKI treatment by the European Medicines Agency in February this year.
AZ said that its drug, a once-daily pill, has been through one of the fastest development programmes ever - from start of clinical trials to approval in just over two and a half years.
Analysts are expecting the drug to pull in peak sales of $3 billion.