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Shock for AZ as MYSTIC trial stumbles at first hurdle

Combination fails to improve progression-free survival for lung cancer patients

AstraZeneca building logo

The results of the long-awaited MYSTIC trial have come through - and the verdict isn’t good for AstraZeneca's ambitions to catch the leaders in the fast-growing immuno-oncology market.

The pairing of AZ's new PD-L1 inhibitor Imfinzi (durvalumab) and CTLA4 blocker tremelimumab - the foundations of its nascent cancer immunotherapy franchise - as well as Imfinzi given on its own failed to improve progression-free survival (PFS) when given to newly-diagnosed non-small cell lung cancer (NSCLC) patients.

That means the trial has already missed one of its primary endpoints, and while AZ said it is continuing the trial to test Imfinzi and the combination's ability to improve overall survival, the company's shares were in freefall this morning - down almost 16% at the time of writing as the company presented its interim results.

The scale of the sell-off reflects the importance attached by investors and analysts to MYSTIC and the first-line NSCLC indication, given that AZ reported another trial in May showing that Imfinzi improved PFS in second-line NSCLC. Jefferies said the readout could make AZ a target for takeover.

A newly-announced collaboration with Merck & Co (known as MSD outside the US and Canada) focusing on PARP inhibitor Lynparza (olaparib) - and positive phase III data for AZ's EGFR inhibitor Tagrisso (osimertinib) - would ordinarily have buoyed the company but wasn't enough to stem the sell-off in the face of the MYSTIC disappointment.

AZ's chief executive Pascal Soriot urged patience on MYSTIC this morning, saying the trial "continues as planned to evaluate overall survival", adding that the company's financial performance is in line with expectations and asserting that AZ has "continued pipeline momentum".

The new Merck collaboration will see Lynparza paired with Merck's PD-1 inhibitor Keytruda (pembrolizumab) - which is way out in front of the immuno-oncology market in first-line NSCLC - as well as Imfinzi which is already approved for bladder cancer and other drugs such as AZ's MEK inhibitor selumetinib.  Soriot said the PARP inhibitor would be "a backbone" of many of the combinations planned by the alliance. Under the terms of the agreement, Merck will pay AZ up to $8.5bn, including $1.6bn upfront.

Meanwhile, Tagrisso hit the mark in the FLAURA trial in first-line NSCLC, improving PFS in patients whose tumours have EGFR mutations, and AZ said it will now start preparations for filing the drug for first-line use in this indication.

The MYSTIC setback may well re-ignite speculation about the future of Soriot, who was rumoured to be planning to leave the company and take the helm of Israeli drugmaker Teva earlier this month but now seems to be staying put. Under his leadership AZ has been steadily selling off assets to invest in its pipeline - with immuno-oncology and particularly lung cancer at its core.

The group reported second quarter sales of just over $5bn, down 10% thanks to the lingering impact of patent losses for big-selling brands, with operating profit flat at $925m.

Article by
Phil Taylor

27th July 2017

From: Research



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