MADRID, Spain—Right now, AstraZeneca’s lung cancer drug Tagrisso is approved to treat only a select group of patients who've previously taken other meds that target tumors with EGFR mutations. But new data rolled out over the weekend could help change that.
Early Saturday at the European Society for Medical Oncology (ESMO) annual meeting in Madrid, the British drugmaker unveiled data it says showcase the “clear potential” for Tagrisso to become the new standard of care for previously untreated lung cancer patients with EGFR gene mutations.
In a phase 3 study, Tagrisso cut the risk of disease progression or death by 54% when pitted against standard-of-care tyrosine kinase inhibitors Tarceva from Roche and Iressa from AstraZeneca. Tagrisso also kept disease at bay for a median 18.9 months, compared with 10.2 months for the standard-of-care meds.
“You’re looking at a substantial improvement in the time that patients have without their tumors progressing,” Andrew Coop, AZ’s VP of U.S. Medical Affairs, Oncology, said Friday ahead of the data presentation. It’s “clinically meaningful to patients and the physicians who are treating these patients.”
What’s more, Tagrisso’s progression-free survival advantage held across patient subgroups; the drug cut the risk of disease worsening or death by 40%, among patients who had brain metastases at the time they enrolled in the study and patients who didn’t.
Patients in the Tagrisso arm also weren’t hit as hard by side effects: 33.7% of them registered an adverse event at Grade 3 or higher, and 13.3% of patients in the group stopped treatment because of side effects. In the standard-of-care group, 18.1% of patients quit treatment and 44.8% of the group experienced heavy side effects.
If Tagrisso can nab a first-line EGFR nod, it would move into earlier stages of treatment and expand its eligible patient pool, which is currently limited to patients with an abnormal T790M gene, after they’ve failed on other treatments. For now, though, AstraZeneca is still discussing a broader approval with regulators, and typically offers updates on those submissions alongside quarterly earnings announcements, the company said.
Physicians Leerink Partners analyst Seamus Fernandez spoke with at ESMO, meanwhile, "largely view it as the new standard of care," he wrote in a note to clients. Conversations he had following the data presentation "suggest that Tagrisso will be adopted as 1L therapy in most patients prior to mature OS data."
AstraZeneca is happy to highlight the new Tagrisso data; company executives have sought to redirect investors’ attention to the EGFR drug from its immuno-oncology combination of Imfinzi and CTLA4 prospect tremelimumab—even before that pairing flopped the phase 3 Mystic study in first-line lung cancer.
On February’s Q4 conference call, CEO Pascal Soriot joked that Tagrisso had “been overshadowed,” adding that while shareholders were right to be “mesmerized” by Mystic, “you’ve got to look at everything we have.”
And thanks to the I-O combo regimen’s showing—it failed to outperform solo Imfinzi or chemo at staving off lung cancer progression—Tagrisso could prove even more important to AZ’s top line. The company is gunning for a lofty $45-billion-by-2023 sales goal, and Soriot himself has said it’ll be “lucky” to hit it.