Imfinzi trial failure prompts withdrawal of indication in USA
Anglo-Swedish pharma major AstraZeneca (LSE: AZN) has announced the voluntary withdrawal of the Imfinzi (durvalumab) indication in the USA for previously-treated adults with locally advanced or metastatic bladder cancer.
In May 2017, the PD-L1 inhibitor had been granted accelerated approval in the USA based on promising tumor response rates and duration of response data from Study 1108, a Phase I/II trial that evaluated the safety and efficacy of Imfinzi in advanced solid tumors, including previously-treated bladder cancer.
"The science of immunotherapy has moved swiftly over the past few years"Continued approval was contingent on results from the DANUBE Phase III trial in the first-line metastatic bladder cancer setting, which did not meet its primary endpoints in 2020.
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