In a pre-specified exploratory subgroup analysis in patients with central nervous system metastases, PFS in the Tagrisso group was 8.5 months versus 4.2 with platinum-pemetrexed chemo (hazard ratio = 0.32) in 34% of patients.
The safety profile of Tagrisso was similar to earlier studies. Grade 3 (severe) or higher treatment-related adverse events were seen in 6% (n=16) of the Tagrisso cohort compared to 34% (n=46) in the chemo cohort.
AstraZeneca executive vice president of global medicines development and chief medical officer Sean Bohen said: “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.
“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.”
The US Food and Drug Administration approved Tagrisso in November 2015 to treat metastatic EGFR T790M mutation-positive NSCLC, who has progressed on or after EGFR TKI therapy.
It was approved in the European Union in February this year and in Japan in March. The marketing application in China is presently under review.
Image: AstraZeneca’s laboratory testing. Photo: courtesy of AstraZeneca.