Dive Brief:
- AstraZeneca's phase 3 trial of its lung cancer drug Tagrisso demonstrated clinically meaningful improvement in progression-free survival, objective response rate, disease control rate, and duration of response compared to platinum-based doublet chemotherapy, the company announced Monday.
- Tagrisso is a second-line treatment of epidermal growth factor (EFGR) mutated non-small cell lung cancer (NSCLC) that targets the T790M mutation, which is present in 10-15% of NSCLC patients in the U.S. The Food and Drug Administration approved the drug in November 2015, pending confirmation from phase 3 trials.
- AstraZeneca is exploring Tagrisso's potential as both a monotherapy and combination treatment to expand the drug's clinical reach. The company has previously predicted the drug could reach blockbuster status by 2020.
Dive Insight:
Tagrisso's accelerated approval in November defined it as one of the fastest drug development programs ever, according to AstraZeneca. The drug took only two and a half years to reach the market after its first clinical trial, winning approval in a wide range of countries.
In the U.S., the drug received accelerated approval from the FDA after two strong phase 2 single-group studies, where 57% and 61% of patients experienced a partial or complete reduction in tumor size. As part of the approval, the FDA also requested an additional phase 3 trial that confirms the phase 2 results.
The preliminary information revealed in the press release implies the AURA3 trial strongly supports the phase 2 data previously presented to the FDA. The specific results, however, are still unavailable and will be released at a later medical presentation.
But AstraZeneca appears to have no doubt about Tagrisso's potential. Upon the drug's approval, the company projected Tagrisso could reach $1 billion to $3 billion in sales by 2020, which would help AstraZeneca toward its lofty goal of $45 billion in total annual sales by 2023.
Perhaps for this reason, the company intends to pursue Tagrisso as a monotherapy and combination therapy for lung-cancer patients with adjuvant or locally advanced metastatic first-line EGFRm settings, as well as those with leptomeningeal disease.
"We remain committed to exploring the potential of Tagrisso to further extend its reach and help meet patient need,” said Sean Bohen, AstraZeneca's Executive VP of Global Medicines Development and Chief Medical Officer.