- AstraZeneca's lung cancer treatment Tagrisso (osimertinib) proved more effective than chemotherapy as a second-line treatment for non-small cell lung cancer (NSCLC), according to new data released Tuesday.
- The data comes about five months after the British pharma released topline results from a Phase 3 trial testing Tagrisso in patients with NSCLC that was locally-advanced or had a specific epidermal growth factor receptor (EGFR) mutation.
- Updated results show treatment with Tagrisso extended median progression-free survival by 5.7 months to 10.1 months, compared to 4.4 months for platinum-based doublet chemotherapy.
The trial also tested the drug in patients with central nervous system (CNS) metastases, and found those treated with it survived 8.5 months without the disease worsening versus 4.2 months under the chemotherapy.
Notably, the hazard ratio for the NSCLC patients was 0.30 (at a 95% confidence interval), indicating treatment with Tagrisso reduced the risk of disease worsening compared to chemo by 70% — a respectable benefit.
“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," AstraZeneca's Chief Medical Officer Sean Bohen said in a Dec. 6 statement.
"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,” Bohen said.
Tagrisso works to block the effects of T790M, a mutation that makes EGFR resistant to inhibitor proteins. EGFR, meanwhile, is a group of enzymes which cause cancer when they themselves undergo mutation.
The Food and Drug Administration approved Tagrisso in December 2015, after two Phase 2 trials showed it was an effective treatment for people with NSCLC that displayed metastatic EGFRs and T790M mutations. The approval came with a couple caveats, however. The drug was paired with a companion diagnostic test that the company was developing with Roche, and had to undergo a confirmatory Phase 3 trial, a requirement fulfilled by the updated results.
The effort is well worth it for AstraZeneca, which forecast in 2014 the drug could contribute about $3 billion in peak sales and help it reach its ambitious $45 billion sales goal by 2023. Tagrisso has earned $276 million for the company year-to-date, according to its most recent quarterly filing with the Securities and Exchange Commission.