In mid-April, at the recommendation of an independent data monitoring committee, AstraZeneca unblinded a phase 3 trial of Tagrisso two years early. Now, the public is getting a look at what prompted the move: results from a study investigators are calling “a home run.”
In postsurgery patients with EGFR-mutated non-small cell lung cancer, Tagrisso cut the risk of disease recurrence or death by a whopping 83% compared with placebo, AstraZeneca revealed ahead of the American Society of Clinical Oncology’s (ASCO's) virtual annual meeting.
Eighty-nine percent of Tagrisso patients were alive at the two-year mark and hadn’t seen their cancer return, compared with just 53% of patients in the placebo group.
“This trial is a home run. It exceeded our expectations,” lead study author Roy Herbst, M.D., Ph.D., said in a statement. Richard Schilsky, M.D., ASCO’s chief medical officer, added that the results “strongly” support Tagrisso’s use earlier in EGFR-mutated lung cancer, “which has a significant risk of recurrence despite surgical treatment and chemotherapy.”
What's more, the "uniformity of benefit across subgroups is really consistent and impressive," Dave Fredrickson, executive vice president and global head of AstraZeneca’s oncology business unit, said. "I think that it really marks a watershed moment for early lung cancer patients and for patients with EGFR-mutated disease," he added.
The adjuvant results crack open a "commercial opportunity that's quite sizable" relative to Tagrisso's current sales, Fredrickson said.
The drug has already blitzed its way to the top of AstraZeneca’s sales ranks, generating $3.19 billion in 2019 on the back of data in previously untreated metastatic EGFR lung cancer patients that made it the standard of care in that setting. And it's on track to surpass $4 billion in 2020 if its first-quarter performance is any indication.
If the drug can win global green lights in the adjuvant setting, it could add about 60,000 patients across the U.S., Europe, Japan and China, which is about a quarter of the size of Tagrisso's current patient pool, Fredrickson noted. But post-surgery patients would also stay on Tagrisso for between two and three years, making the opportunity "really significant."
SVB Leerink analyst Andrew Berens, for his part, expects to see swift uptake, with "superlative efficacy likely to rapidly establish Tagrisso adjuvant usage as standard of care," he wrote in a Friday note to clients. After seeing the data, Berens upped his estimate for peak adjuvant sales to $5.6 billion from $1.5 billion, bringing his prediction for Tagrisso's total worldwide sales to about $16 billion.
Of course, to fully capture that opportunity, AstraZeneca will need to make sure EGFR mutation testing is happening in all patients with tumors that can be surgically removed, which is "not the standard at all" in the U.S. or around the world, Fredrickson said. "But we also know that data like these create a reason for testing to take place," he said, adding that "these data are going to create several imperatives with respect to the identification, diagnosis, treatment and management of lung cancer."
The way Fredrickson sees it, driving testing shouldn't be a problem with the new results in hand. EGFR testing is "already quite established" in the metastatic setting, and "the availability of tissue is high."
"I've got the confidence we'll really be able to see a move in the right direction as rapidly as possible," he said.
Instead, it's increasing lung cancer screening that's "a monumental task," and that's an area the British drugmaker and its partners are "really ... putting our time and attention into."
Meanwhile, the adjuvant study—called Adaura—will continue to see whether Tagrisso can extend postsugery patients’ lives.