AstraZeneca’s cancer immunotherapy enters Phase 3 trials

AstraZeneca has announced the start of the Phase 3 trials for MEDI4736, a new immunotherapy treatment for non-small cell lung cancer and other cancers.

The company is particularly keen to highlight the drug's progress into phase 3 as it seeks to convince shareholders to reject Pfizer's expected takeover bid.

The Anglo-Swedish company is pulling out all the stops in highlighting the promise of its pipeline, presenting a full pipeline review on Monday, including bullish earnings forecasts for its most promising drugs.

Among these was MEDI4736, a human monoclonal antibody which targets programmed cell death ligand 1 (PD-L1). This ligand helps cancer cells avoid detection by the body's immune system, and by blocking its action, the drug helps the body's immune system identify cancer cells and kill them off.

The PACIFIC trial will compare the drug to placebo in patients with locally advanced, unresectable NSCLC (Stage III) following completion of treatment with chemoradiotherapy and no evidence of tumour progression. The PACIFIC trial is the first pivotal study of an immunotherapy in this patient population.

Briggs Morrison, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca said: "MEDI4736 is an important molecule in our immuno-oncology portfolio and its entry into Phase III clinical trials is further evidence of our commitment to invest in distinctive science in our core therapy areas, and to rapidly progress our immuno-oncology pipeline."

Lung cancer remains the most deadly cancer of all, and despite a huge amount of R&D time and money spent on targeting it, even the latest treatments cannot delay its progress for very long.

Morrison said: "We believe MEDI4736, and immunotherapies more broadly, hold the potential to shape the future of cancer treatment."

Competition from BMS, Merck and Roche

However there is plenty of competition in this field, with three companies having candidates with similar mechanisms of action. Bristol Myers Squibb is developing nivolumab, an anti-PD-1 antibody. Merck has lambrolizumab, and Roche is developing anti-PD-L1 antibody MPDL3280A.

Analyst estimates for Roche's drug, seen as a potential market leader, stood around the $2.5-3 billion mark late last year, but AstraZeneca has suggested its own drug could earn far more than that.

AstraZeneca said on Monday that MEDI4736 could earn around $6.5 billion in peak sales, very much at the higher end of analyst estimates of $2 billion – 7 billion.

Many analysts have reacted with scorn at AstraZeneca's forecast for this and other drugs still undergoing clinical trials, but its optimistic estimates clearly reflect its attempts to repel Pfizer's bid.

It was AstraZeneca's oncology pipeline which Pfizer's management highlighted as one of the key assets it wanted to acquire in the mooted takeover – although it is generally agreed that the opportunity to switch to a UK tax base UK tax base is the chief motivation for the takeover bid.

Links

AstraZeneca takeover could spell end of big pharma in Sweden