AstraZeneca surges on good news from lung cancer trial

AstraZeneca's durvalumab immuno-oncology drug has become the first such medicine to successfully treat advanced lung cancer patients who had not had success with chemotherapy.

The drug, which is branded Imfinzi, was found during a mid-trial analysis conducted by an independent committee to have already met a primary endpoint by showing statistically-significant and clinically-meaningful progression-free survival in patients receiving Imfinzi compared to placebo for locally-advanced, non-small cell lung cancer that cannot removed by surgery.

Analysts said the market opportunity could be more than $4bn.

"These are highly encouraging results for patients with locally-advanced lung cancer for whom surgery is not an option," said Sean Bohen, Astra's chief medical officer.

"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."

Imfinzi/durvalumab is a human monoclonal antibody that counters a tumour's immune-evading tactics and inducing an immune response, through its action as an inhibitor of the PD-L1 protein.

AstraZeneca's MedImmune arm, which carries out global biologics research and development, has been examining the effetcs of Imfinzi as part of its 'Pacific' trial, a randomised, double-blinded, placebo-controlled multi-centre trial as a sequential treatment in unselected patients with locally-advanced, unresectable (stage III) NSCLC who have not progressed following platinum-based chemotherapy concurrent with radiation therapy.

According to data from Astra this morning, in G7 countries around 47,000 patients would meet the criteria for treatment as defined by this trial.

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Saying the successful completion of the trial at an interim analysis "is good news", analyst Alistair Campbell at Berenberg noted that the Pacific tests were looking at inoperable, non-small cell lung cancer, but before it has metastasised, pointing out that this was an earlier setting than Astra's 'Mystic' trial and an area where Merck's Keytruda, Bristol-Myers Squibb's Opdivo and Roche's Tecentriq are not already approved.

"The trial was expected to read out in late 2017, but has read out early at the interim analysis – that is usually a sign of better-than-expected efficacy."

It added: "If we assume treatment duration of 12 months and an average global price of $90,000 for Imfinzi, then the market opportunity would be over $4bn... So while the market was waiting for MYSTIC as the next major immuno-oncology catalyst, Pacific has read out early, caught us by surprise, and actually could be meaningful for sales."

Campbell said it was another important clinical trial success that is likely to help Astra return to robust sales and earnings growth from 2018 onwards, and not only lessens the reliance on Mystic but also provides more reassurance that Imfinzi "is an active drug and therefore must have a chance of working in Mystic".

In a note issued on Friday before the Imfinzi announcement, Jefferies said in a note that MYSTIC data could be "top lined"
in June and could "drive a share price move of circa 20% in either direction in our view".