AstraZeneca bolstered by FDA news on lung cancer drug Imfinzi

Reuters

Reuters

AstraZeneca also announced its immunotherapy drug Imfinzi had been granted "breakthrough" designation by United States regulators for treating non-metastatic lung cancer following the success of the so-called Pacific trial.

The regulator has granted breakthrough therapy designation, created to accelerate the review of new medicines for treating serious conditions that have demonstrated encouraging early clinical results. "Unfortunately, for the majority of patients, their cancer will progress to metastatic disease, typically within 12 months", said Sean Bohen, chief medical officer at Astrazenca.

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The PACIFIC trial is a randomised, double-blinded, placebo-controlled multi-centre trial of Imfinzi as sequential treatment in unselected patients with locally-advanced, unresectable (Stage III) NSCLC who have not progressed following platinum-based chemotherapy concurrent with radiation therapy.

The U.S. Food and Drug Administration decision clears the way for a speedy regulatory review and comes a day after another of its drugs, Imfinzi, won breakthrough designation for non-metastatic lung cancer.

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As a secondary endpoint, although not formally tested, Imfinzi monotherapy would not have met a pre-specified threshold of PFS benefit over standard of care in this disease setting, AZ said.

It is also being tested in the adjuvant NSCLC setting in the ADJUVANT phase 3 trial.

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The sale was disclosed in a filing with the Securities & Exchange Commission, which is accessible through this hyperlink . Last time, the company shocked Wall Street by reporting EPS of $1.24, smashing the consensus of $1.20 per share.

Opdivo had an early advantage as it was first to market but Keytruda is catching up in sales after approval in the lucrative first-line lung cancer indication, where the BMS drug failed in a shock set of clinical trial results around a year ago. The trial will, however, continue to assess two additional primary endpoints of overall survival for both Imfinzi monotherapy and the Imfinzi plus tremelimumab combination, with results expected in the first half of next year.

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