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AZ withdraws Imfinzi in the US for advanced bladder cancer after post-marketing study fail

Immunotherapy failed to hit primary endpoint in phase 3 DANUBE trial last year

AstraZeneca has announced it will voluntarily withdraw Imfinzi’s US indication for advanced bladder cancer after a post-marketing study failed to hit the mark.

In May 2017, the US Food and Drug Administration (FDA) granted Imfinzi (durvalumab) an accelerated approval for the second-line treatment of locally advanced or metastatic bladder cancer.

However, the continued approval of Imfinzi in this indication was dependent on the results from the phase 3 DANUBE trial in the first-line metastatic bladder cancer setting.

In the DANUBE trial, Imfinzi monotherapy was tested in patients whose tumours had elevated expression of the PD-L1 biomarker, while the combination with tremelimumab was trialled in ‘all-comer’ patients regardless of their PD-L1 status.

Unfortunately, Imfinzi failed to hit the primary endpoint in this trial, and the PD-L1 inhibitor was unable to improve overall survival in patients with advanced bladder cancer compared to chemotherapy alone.

After failing to meet this post-marketing requirement, AZ has chosen to remove Imfinzi in this indication – a decision that was made in consultation with the FDA.

“While the withdrawal in previously treated metastatic bladder cancer is disappointing, we respect the principles the FDA set out when the accelerated approval pathway was founded and remain committed to bringing new and innovative options to patients,” said Dave Fredrickson, executive vice president, oncology business unit, AZ.

“In the last three years, Imfinzi has become an important standard of care in multiple lung cancer settings, an area of considerable focus for AstraZeneca,” he added.

Despite the withdrawal, AZ still has several phase 3 trials testing Imfinzi in various treatment combinations for early- and late-stage bladder cancer.

This includes the phase 3 NILE trial in metastatic disease, the phase 3 NIAGARA trial in muscle invasive disease and the phase 3 POTOMAC trial in non-muscle invasive bladder cancer (NMIBC).

A number of immunotherapies are approved for bladder cancer, including Merck & Co/MSD’s Keytruda (pembrolizumab) which became the first checkpoint inhibitor to be approved in the US for NMIBC in 2020.

Roche’s Tecentriq (atezolizumab) was also the first checkpoint inhibitor to be approved for first-line bladder cancer therapy in patients unable to receive first-line chemotherapy in 2017.

Article by
Lucy Parsons

23rd February 2021

From: Regulatory



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