Imfinzi misses endpoint in Phase III bladder cancer trial

There was disappointment this morning for AstraZeneca (LSE: AZN) in its bid to gain a first-line indication for its PD-L1 inhibitor Imfinzi (durvalumab) in bladder cancer, sending the Anglo-Swedish drugmaker’s shares down more than 2% to 7,343 pence by mid-morning.

The Phase III DANUBE trial for Imfinzi and Imfinzi plus tremelimumab in unresectable, Stage IV (metastatic) bladder cancer did not meet the primary endpoints of improving overall survival (OS) versus standard-of-care (SoC) chemotherapy for Imfinzi monotherapy in patients whose tumor cells and/or tumor-infiltrating immune cells express high levels (≥25%) of PD-L1, or for Imfinzi plus tremelimumab in patients regardless of their PD-L1 expression.

Imfinzi is already approved for patients with locally advanced or metastatic bladder cancer previously treated with platinum-containing chemotherapy in 15 countries, including the USA, as well as in lung cancer in 61 countries.