Friday Five - This week's key news stories

AstraZeneca ups its IO game

AstraZeneca's Imfinzi has been approved in the US for the treatment of Stage III unresectable non-small-cell lung cancer (NSCLC) in patients who initially respond to concurrent chemotherapy and radiation therapy (CRT). Analysis - ViewPoints: AstraZeneca's trend-setter status confirmed.

A monopoly position in this indication beckons for a few years at least, with blockbuster sales in the offing; though feedback from oncologists indicates prescribers may be comfortable using alternative PD-1 and PD-L1 inhibitors in this setting on an off-label basis.

See Physician Views Poll Results: Imfinzi uptake will be swift, but does off-label use of other PD-(L)1's pose a threat to AstraZeneca's opportunity in Stage III lung cancer?

Regardless, however, Imfinzi should now further revitalise AstraZeneca's oncology portfolio.

Will Pfizer acquire to up its own?

Elsewhere in immuno-oncology development, partners Merck KGaA and Pfizer confirmed late last week that the PD-L1 inhibitor Bavencio failed to better chemotherapy in second-line metastatic NSCLC patients; a result blamed on an exceptionally high level of patient crossover. Analysis - ViewPoints: Pfizer, Merck KGaA still waiting for combos to save Bavencio.

That said, this setback will increase speculation that Pfizer could acquire a more advanced player in the immuno-oncology space in order to close the gap on rivals; speculation in recent months has centred on a potential buyout of Bristol-Myers Squibb. Analysis - ViewPoints: Is a Pfizer M&A play in immuno-oncology inevitable?

Deal watch

Merck & Co. is to pay a significant premium to acquire Viralytics for $394 million, raising expectations that positive early-stage data will soon read out for the combination of Merck's Keytruda and Viralytics' oncolytic virus product Cavatak. Analysis - ViewPoints: Merck & Co. hits on a viral strategy to stay in the I/O game.

AbbVie has agreed a heavily back-loaded deal to co-develop a vectorised monoclonal antibody product directed against tau with Voyager Therapeutics. The ambitious project is to develop a one-time treatment for Alzheimer's disease and other neurodegenerative conditions. Analysis - ViewPoints: AbbVie buys in on Voyager’s marriage of gene therapy, mAbs for Alzheimer’s disease.

FDA looks to support pharma's Alzheimer's disease quest

AbbVie and Voyager have lofty ambitions in a complex disease area where drug development failures have historically outnumbered incredibly rare successes; which have also been achieved at improving symptoms associated with Alzheimer's disease rather than the underlying disease.

Acknowledging these challenges, the FDA has released draft guidance that it hopes will support new approaches to studying very early disease before the onset of dementia, including strategies for clinical studies incorporating patients yet to experience any visible impairment in the form of cognitive or functional deficit, but who may be identified through other means, including a better understanding of biomarkers. Analysis - ViewPoints: New FDA guidance contains good news for Alzheimer’s disease drug developers.

Investors not nutty for AR101 safety data

Could an effective treatment for preventing allergic reaction to peanuts offer significant commercial returns? Investors in Aimmune Therapeutics remain hopeful this is the case and new Phase III data, announced this week, points to an impressive efficacy profile for lead asset AR101.

But a compelling safety profile is imperative for a drug such as this and investors were left disappointed in particular by a higher than expected discontinuation rate in Aimmune's pivotal-stage trial. Analysts were quick to argue that regulators would likely still view AR101 as approvable, but concerns over safety would no doubt weigh on commercial performance. Analysis - ViewPoints: Aimmune has some convincing to do on AR101’s safety profile.

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