AstraZeneca’s flagship Tagrisso helps lung cancer patients live longer in pivotal study

In Clinical Trials by Barbara Jacoby

By: Natalie Grover

From: endpts.com

AstraZeneca is off to a good start in August. After its PARP inhibitor Lynparza scored in a prostate cancer trial earlier this week, the British drugmaker on Friday disclosed that its star cancer drug Tagrisso helped patients with a certain type of lung cancer live longer in a late-stage study.

The overall survival data follows positive progression-free survival data unveiled in 2017 from the FLAURA Phase III trial involving patients with metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC). AstraZeneca estimates roughly 10-15% of patients in the US and Europe, and 30-40% of patients in Asia have EGFR-mutated NSCLC.

In the first half of 2019, Tagrisso was AstraZeneca’s $AZN biggest seller, raking in $1.4 billion in sales. The drug is currently approved in 74 countries, including the United States, Japan and the EU for first line EGFR-positive metastatic NSCLC.

The FLAURA trial assessed the efficacy and safety of Tagrisso orally once daily against comparator treatments (either Tarceva from Roche and Astellas or Iressa from AstraZeneca’s own arsenal) in 556 patients across 29 countries. Data showed the drug nearly doubled median progression-free survival to 18.9 months versus 10.2 months achieved by Tarceva and Iressa.

On Friday, AstraZeneca said Tagrisso conferred a statistically-significant and clinically-meaningful improvement in overall survival — although details will be provided at a later date.

Lung cancer is the leading cause of cancer death globally, according to the WHO. The two main types of lung cancer are non-small cell and small cell, and NSCLC accounts for about 85% of all cases. Lung cancer has a poor prognosis; statistics suggest over half of people diagnosed die within one year of diagnosis and the average 5-year overall survival rate is less than 18%.

Considered one of the most commercially rewarding conditions to treat, AstraZeneca had pinned its hopes on the combination of its checkpoint inhibitor Imfinzi with its in-house CTLA-4 drug in the keenly watched MYSTIC trial earlier this year, but that bet proved costly. Imfinzi is now in development as a monotherapy, as well as a chemotherapy combination, for lung cancer patients without a known genetic mutation.

Despite a string of high-profile misses, chief Pascal Soriot has made strides in his mission to fix AstraZeneca’s once-ailing portfolio bruised by generic medicines eating into sales. The company has since sharpened its focus on the lucrative field of oncology with drugs such as Lynparza, Tagrisso and Imfinzi. In 2016, Soriot had touted Tagrisso as a $3 billion annual earner, a key feature in his big promise to deliver $45 billion in annual revenue in 2023.