After 18 years in development, AstraZeneca’s CTLA-4 antibody gets the red carpet treatment at the FDA

After a decade, a second CTLA-4 antibody may finally be on its way to approval.

AstraZeneca announced Monday that the FDA had given priority review to tremelimumab, its long-gestating CTLA-4 antibody, in combination with the PD-L1 inhibitor Imfinzi for patients with liver cancer that can’t be treated with surgery.

The Big Pharma’s application is based on a multi-year, 1,324-patient study that showed 30.7% of patients who received a “priming dose” of tremelimumab followed by Imfinzi were alive after three years, compared to 20.2% of patients who received Bayer’s sorafenib, the standard of care.

Susan Galbraith, AstraZeneca’s cancer R&D chief, called that data “unprecedented.” Others raised questions about how the data held up compared to an alternative treatment regimen being developed by Roche, and how much benefit the CTLA-4 antibody offered, given that patients who received Imfinzi alone showed nearly identical survival at the two-year mark. The difference only emerged after three years.

Click here to read the full article at Endpoints News

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