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AstraZeneca's Imfinzi fails to meet endpoint in Phase 3 trial

ALN

AstraZeneca PLC on Thursday said that a Phase 3 trial for its immunotherapy Imfinzi did not achieve its primary endpoint in the treatment of patients with locally advanced cervical cancer.

The Cambridge, England-based pharmaceutical company said that Imfinzi was given in combination with chemoradiotherapy in the trial.

The immunotherapy did not achieve statistical significance for the primary endpoint of improving progression-free survival compared to chemoradiotherapy alone.

AstraZeneca said that 770 patients with locally advanced cervical cancer were treated in the trial. It was conducted at 120 centres across 15 countries.

Imfinzi is approved in the US, EU, Japan, China and ‘many other countries’ for the treatment of extensive-stage small-cell lung, the company said.

As part of a broad development programme, Imfinzi is being tested as a single treatment and in combination with other anti-cancer treatments for patients with small-cell lung cancer, non-small cell lung cancer, bladder cancer, several gastrointestinal cancers, ovarian cancer, endometrial cancer and other solid tumours, it continued.

‘While today's results were not statistically significant, they underscore the need for further evaluation of novel therapeutic options and will inform future strategies to improve treatment for patients with locally advanced cervical cancer,’ Bradley Monk, principal investigator in the Callla phase III trial, said.

Shares were up 0.5% at 9,780.00 pence each on Thursday morning in London.

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