The good news just keeps rolling in for AstraZeneca’s Tagrisso--and this time, it’s in the form of positive Phase III data.
The British pharma giant announced on Monday that its AURA3 trial--which assessed the med as a second-line treatment in advanced EGFR mutation-positive non-small-cell lung cancer--had met its primary endpoint, with Tagrisso posting superior progression-free survival compared with platinum-based doublet chemo.
The 400-patient study follows up on Tagrisso's speedy approval, which the FDA made contingent on data confirming its worth. Next up: testing the drug in previously untreated patients, a larger population that would give Tagrisso a leg up on sales growth.
It’s a positive development for the oncology med as it works its way toward the blockbuster benchmark. AstraZeneca has predicted peak sales of $3 billion for the product, which netted $51 million in first-quarter sales and $19 million between its late November launch and the close of 2015.
Hitting the $1 billion milestone isn’t a sure thing, though. For one, the drug requires a diagnostic to sift out patients with the genetic mutation Tagrisso treats, and EGFR mutation testing was only at about 10% before the drug made its entrance. That percentage has rocketed upward by 40%, company EVP Luke Miels said on AZ’s Q1 earnings call, but there’s still work to be done.
Luckily for AstraZeneca, Tagrisso will be gunning for blockbuster land with less competition than previously expected. In May, Clovis Oncology bagged its wannabe rival, rociletinib, following a 12-to-1 FDA panel rejection; at one time, the company was trumpeting better response rates than AZ could muster, but those were unconfirmed responses that ruffled the feathers of regulators.
But AZ will need to widen Tagrisso’s label if it really wants the drug to soar. In addition to trials in a first-line setting, AstraZeneca is in the process of testing it alongside its PD-L1 immunotherapy candidate durvalumab.
- read the release
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