Phase 3 failure for AstraZeneca's Imfinzi combo in unresectable metastatic bladder cancer

New Phase 3 has been released by AstraZeneca, showing that the PD-L1 inhibitor Imfinzi (durvalumab), when combined with tremelimumab, failed to meet its primary endpoint in the treatment of unresectable metastatic bladder cancer.

Specifically, the study was investigating the therapy’s efficacy in adult patients in whom over 25% of their tumour cells express PD-L1, or in patients receiving the combo regardless of PD-L1 expression.

The findings of the study revealed that the combo failed to provide improved overall survival benefit compared to standard-of-care chemotherapy. However, its safety profile was found to be in line with previous data.

“AstraZeneca remains committed to addressing unmet needs in bladder cancer and the potential for immunotherapy to improve outcomes for these patients,” explained José Baselga, AZ’s Executive Vice President, Oncology R&D. “The results from this trial will inform our comprehensive Phase III development programme in bladder cancer. We look forward to the results of the Phase III NILE trial also in the 1st-line metastatic setting, and we continue to advance clinical trials for patients at earlier stages of the disease.”

In addition to this indication, Imfinzi is also being trialled in earlier stage bladder cancer in combination with chemotherapy. It has already secured approval in 15 countries for locally advanced or metastatic bladder cancer previously treated with platinum-containing chemotherapy, including in the US.

Matt Fellows