When it comes to AstraZeneca blockbuster Tagrisso, Wolfe Research analyst Tim Anderson laid things out simply in a Friday note to clients: “A major new commercial opportunity just opened up.”
At the recommendation of an Independent Data Monitoring Committee, the drugmaker will unblind a phase 3 trial of Tagrisso in postsurgery patients with EGFR-mutated non-small cell lung cancer two years ahead of schedule after the drug posted a significant benefit.
“This is a major win for AstraZeneca,” Anderson wrote.
The hot-selling pill went up against placebo, with investigators measuring disease-free survival over a treatment period of up to three years. And Tagrisso showed an "unprecedented level of clinical benefit" that has the company "very excited," José Baselga, EVP of oncology R&D, said.
“I don't recall myself a trial being unblinded so early,” he added.
Details of the win will stay under wraps for now, with the company planning to unveil them at a future medical meeting. But in the meantime, “plans for regulatory submission are already underway,” AZ said. The unblinded study, called Adaura, will also continue to see whether Tagrisso can meet the secondary endpoint of extending patients’ lives.
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The adjuvant performance could open up a whole new realm of sales for Tagrisso, which is already AstraZeneca’s best-seller thanks to its success in the metastatic setting. A new OK could add billions of dollars in additional sales, Anderson noted, pointing out that regulatory green lights across the U.S., EU, Japan and China could widen AZ’s patient pool by 30,000.
While that “may not sound like a large number,” patients receive Tagrisso for up to three full years post-surgery. And that would provide AstraZeneca “a very sizeable, incremental revenue stream even when taking into account EGFR testing rates, surgical resection rates and market access consideration,” the analyst wrote.
Speaking of testing rates, that's an area where AZ would like to spur some change. "The important thing in this day in age is testing, testing, testing," Baselga said. "... An awareness movement or effort to make sure that every single patient gets tested, to me, is going to be absolutely critical."
Luckily, the company already has some experience in that department.
"I would imagine a very similar process to the one we have done with metastatic disease," Baselga said of the awareness push. "I think the message is, 'You gotta test, and you gotta test as early as possible.' It should be in the minds of everybody."
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By Anderson’s calculations, sales of Tagrisso—which generated $3.2 billion last year on the back of 71% year-over-year growth—could leap to $4.5 billion in 2020 and $8 billion by 2030.