AstraZeneca's Tagrisso, aiming for $3B in sales, trounces chemo in new phase 3 trial

• The results have AZ execs talking up their case for Tagrisso as a new standard of care in certain patients.
• The new data come as a welcome boost as AZ labors toward a $45 billion revenue goal for 2023, even as its previous top seller, the statin drug Crestor, suffered from new generic competition. The company is cutting costs in the meantime to preserve its R&D investment in the face of lagging sales.
• Dubbed AURA3, the trial compared Tagrisso with chemo in 419 patients with epidermal growth factor receptor T790M mutation-positive, advanced non-small cell lung cancer. The patients had already failed after treatment with an EGFR-targeted tyrosine kinase inhibitor.
• Tagrisso improved progression-free survival by 5.7 months when compared to chemo—10.1 months versus 4.4 months—and lowered patients’ risk of disease progression by 70%, AZ reported Tuesday. For those 34% of patients with central nervous system metastases, an especially worrisome target, the AstraZeneca pill increased progression-free survival by 4.3 months over chemo.
• It’s welcome news for a drug that’s already riding strong momentum. In the first nine months of this year, Tagrisso has contributed (PDF) $276 million in sales. Execs have said the pill can reach $3 billion in peak annual sales, with recent analyst estimates cited by Reuters projecting $2.5 billion in 2022 sales.
• And the new results come after Clovis Oncology canceled development of its would-be rival, giving AstraZeneca exclusive access in its market niche.
• Granted accelerated approval a year ago by the FDA, Tagrisso’s new confirmatory data suggest that the med could “replace chemotherapy as the standard of care for patients who have progressed following EGFR tyrosine kinase inhibitor treatment,” AZ chief medical officer Sean Bohen said in a statement.
• Following its approval, AZ priced Tagrisso at $12,750 per month, or $153,000 for a full year of treatment, hoping to get the most out of a critical launch in its quest to reach $45 billion in annual sales by 2023. So far, the lung cancer drug is approved in the U.S., EU, Japan and other countries. It’s under a fast track review in China, where the EGFR mutation is prevalent in lung cancer patients, the company said.
• In the U.K., the hometown pharma expressed anger this summer when cost-effectiveness gatekeepers turned away the med on a preliminary basis. Tagrisso later became the first med available on the revamped Cancer Drugs Fund in what one patient advocate called a “breakthrough moment” for patients there.
• AstraZeneca CEO Pascal Soriot said his company can reach $45 billion in sales by 2023 as part of his defense to Pfizer’s takeover attempt. He's since softened that goal somewhat.
• Though AZ beat analyst targets earlier this year, it turned in a miss for Q3 and its top line is down from 2015—mostly thanks to Crestor's patent loss—though respiratory blockbuster Symbicort and diabetes meds Byetta and Bydureon suffered as well.
• Tagrisso has been a bright spot, however. Its Q3 sales came in above expectations at $133 million, up quite a bit from the $92 million in posted in the second quarter.
• In an move to trim some expenses, AZ this week said it'd move some finance jobs out of the U.K. to Malaysia, Costa Rica and Poland.

Astrazeneca s tagrisso, aiming, sales, trounces chemo, new phase 3 trial