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AZ buoyed by Imfinzi lung cancer trial

Phase III study shows PD-L1 inhibitor increased progression-free survival

AstraZeneca

AstraZeneca has been boosted by a phase III trial showing its PD-L1 inhibitor Imfinzi increased progression-free survival (PFS) when used as a monotherapy in lung cancer, despite all eyes being on an upcoming combination study.

The PACIFIC trial showed that Imfinzi (durvalumab) improved PFS compared to placebo in patients with advanced, inoperable and chemotherapy-resistant non-small cell lung cancer (NSCLC) who had not progressed after first-line chemotherapy and radiotherapy.

It's a major coup for Imfinzi, which only just picked up its first approval - for bladder cancer - and is playing catch-up in the PD-1/PD-L1 inhibitor category with four other drugs reaching the market before it.

The trial wasn't on the radar of many analysts, who have suggested Imfinzi's fortunes will rely on the MYSTIC trial in first-line NSCLC, where it will be given as a monotherapy and alongside CTLA4 inhibitor tremelimumab. With positive data from PACIFIC in hand, investors helped push AZ to a 5% share price rise ahead of the weekend.

Leerink analyst Seamus Fernandez called the data an "early upside surprise" as it gives AZ a slice of the NSCLC monotherapy market currently unaddressed by rival checkpoint inhibitors such as Bristol-Myers Squibb's Opdivo (nivolumab), Merck & Co's Keytruda (pembrolizumab) and Roche's Tecentriq (atezolizumab).

Deutsche Bank said in a research note that the results "could open a market opportunity of $1.75bn to $3.5bn (or more) for the drug, which is not included in our current forecasts."

AZ is claiming to be at least two to three years ahead of its competitors in this indication, and the company is planning to file quickly with regulators to press its advantage. PACIFIC is also evaluating overall survival as the other main outcome measure, which AZ said will be "assessed in due course as specified by the protocol".

"These are highly encouraging results for patients with locally-advanced lung cancer for whom surgery is not an option," said AZ's chief medical officer Sean Bohen. "We look forward to working with regulatory authorities around the world to bring Imfinzi to lung cancer patients as soon as possible."

Analysts also suggest that the data raise expectations that the MYSTIC trial will be positive for both Imfinzi monotherapy and the combination with tremelimumab when it reads out in the summer, and this could give AZ the ammunition it needs to take on Keytruda in the first-line NSCLC setting.

Meanwhile, AZ also has a head-to-head trial comparing Imfinzi to standard chemotherapy in first-line NSCLC patients whose tumours express PD-L1.

The unexpected positive shows once again that there is all to play for in the checkpoint inhibitor market, and the fortunes of a drug can turn on the outcome of a single study. BMS' discovered this to its cost when Opdivo flunked a first-Line NSCLC trial last year, while Roche was blind-sided last week by a negative confirmatory phase III trial for Tecentriq in bladder cancer.

Article by
Phil Taylor

15th May 2017

From: Research

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