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In a rare blockbuster performance for AstraZeneca, Tagrisso comes through on lung cancer PhIII

AstraZeneca CEO Pascal Soriot

AstraZeneca CEO Pascal Soriot

For a Big Pharma company that often gets things wrong, Tagrisso has been AstraZeneca’s ace in the hole. Sped through the clinic to a first approval in an astonishing two years, it was already on the market when Clovis’ rival imploded on arrival at the FDA.

Today, the pharma giant is pulling back the veil off of new data demonstrating a 5.7-month improvement in progression-free survival of non-small cell lung cancer among patients with an epidermal growth factor receptor (EGFR) T790M mutation compared to platinum-based doublet chemotherapy (10.1 months vs 4.4 months). And the PFS spread significantly favored Tagrisso among the one-third of patients with CNS metastases.

Tagrisso, AstraZeneca execs say now, is poised to become the standard second-line treatment for lung cancer patients with this mutation.

That is exactly the kind of thing AstraZeneca CEO Pascal Soriot needs to hear a lot more about. Soriot tapped Tagrisso as a $3 billion annual earner, a key feature in a big promise to deliver $45 billion in annual revenue in 2023.

The company has started backing away from that overall figure, but expanding the market for Tagrisso will go a long way to convincing investors there are bright spots in a year dominated by setbacks.

Sean Bohen

AstraZeneca CMO Sean Bohen

Clovis helped. The biotech had played fast and loose with data for its rival roci, which attracted plenty of unwanted attention at the FDA. The agency spurned the drug and Clovis opted to restructure and dump the drug.

AstraZeneca CMO Sean Bohen had this to say:

“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.”


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RAPS Regulatory Convergence 2017