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AstraZeneca’s Imfinzi meets primary endpoint in phase 3 NSCLC trial

PBR Staff Writer Published 15 May 2017

AstraZeneca’s Imfinzi (durvalumab) has significantly reduced the risk of disease worsening or death in patients with third stage lung cancer in a phase 3 trial.

The company’s MedImmune unit carried out the Pacific trial, met one of its primary endpoint of progression-free survival (PFS) in patients with locally-advanced, stage three non-small cell lung cancer (NSCLC).

Held at multiple centres, the trial included patients who were ineligible for surgery and whose disease had not progressed after receiving standard platinum-based chemotherapy simultaneously with radiation therapy.

The PFS in the Imfinzi arm was shown to be statistically-significant and clinically-meaningful in patients subjected to placebo.

Following the release of its interim analysis of the phase 3 trial, AstraZeneca stated that Imfinzi has become the first immuno-oncology medicine to demonstrate superior PFS in the maintenance setting.

The other primary endpoint of the trial is overall survival (OS) which AstraZeneca said will be evaluated in due course of time.

AstraZeneca global medicines development executive vice president and chief medical officer Sean Bohen said: “These are highly encouraging results for patients with locally-advanced lung cancer for whom surgery is not an option. We look forward to working with regulatory authorities around the world to bring Imfinzi to lung cancer patients as soon as possible.

“Alongside this, we continue to explore Imfinzi’s full potential as monotherapy as well as in combination with tremelimumab and other medicines in areas of continued unmet need across multiple types of cancer.”

Secondary endpoints of the phase 3 Pacific trial that are being evaluated are landmark PFS and OS, objective response rate and duration of response among others.

Image: AstraZeneca’s lung cancer drug Imfinzi was shown to improve PFS significantly in a phase 3 trial. Photo: courtesy of AstraZeneca.