Friday Five – This week’s key news stories

Keytruda keeps coming

Merck & Co. provided a heck of an appetizer ahead of the impending non-small-cell lung cancer (NSCLC) bonanza at this weekend’s American Association for Cancer Research (AACR) meeting when the company reported Phase III Keynote-042 data indicating that single agent Keytruda (pembrolizumab) may have raised the bar for other immuno-oncology (I/O) rivals in the front-line treatment setting.

Investors are poised to pore over detailed results from high-profile studies like CheckMate-227 of Bristol-Myers Squibb’s Opdivo (nivolumab) and Keynote-189 of Keytruda that will be presented together on April 16, but analysts believe they will have to do so using Keytruda’s performance in Keynote-042 as the new baseline for a majority of patients.

See ViewPoints: Keytruda raises bar again for anti-PD-(L)1 drugs in 1L lung cancer

ECHO-301 reverberates

Not everything Merck touched turned to gold, however, as it and partner Incyte announced late last week that epacadostat had failed in the all-important Phase III ECHO-301 trial, as the IDO inhibitor was found to add nothing when combined with Keytruda in newly diagnosed patients with advanced melanoma.

Epacadostat has been the flagbearer for IDO inhibitors, which was once seen as a must-have class of next-generation I/O agents. Doubts crept in about the pathway after the likes of Pfizer and Roche abandoned respective programmes, which will inevitably be fanned by the ECHO-301 readout.

The aftermath saw Incyte shares receive a 23-percent haircut, though the company said it has not yet given up on epacadostat and plans to continue a fleet of ongoing Phase III trials of it in various solid tumours. Thankfully, it has several revenue-generating products and a fully stocked pipeline to fall back on.

NewLink Genetics, apparently less optimistic about the class, announced a review of its pipeline, which includes a pair of IDO inhibitors in human testing. Testing of at least one more late-stage programme looks set to continue as Bristol-Myers Squibb is conducting a Phase III trial combining BMS-986205 with its Opdivo (nivolumab) in front-line melanoma.

See ViewPoints: ECHO-301 failure will reverberate throughout I/O universe

Novartis comes for Biogen’s SMA crown

Biogen and partner Ionis Pharmaceuticals have enjoyed a strong early launch with Spinraza (nusinersen), a subcutaneous spinal muscular atrophy (SMA) drug dosed every three months, but there have long been questions about how much of a threat is posed by one-time gene therapies.

Whatever concerns investors may have been harbouring just got amplified – bigly – after Novartis agreed this week to pay $8.7 billion to acquire AveXis to get its hands on AVXS-101, the most advanced SMA gene therapy in development, significantly increasing the amount of marketing muscle behind the product.

See ViewPoints: Bogey on Spinraza’s radar just got a whole lot bigger

MODUL muddled

Suspension of the Phase II MODUL trial combining Roche’s anti-PD-L1 mAb Tecentriq (atezolizumab) and Exelixis’ MEK inhibitor Cotellic (cobimetinib), necessitated by an imbalance of deaths including at least one case of treatment-related case of cardiotoxicity, but the impact was not evenly dispersed between the two companies as shares of the Swiss drugmaker were relatively flat while the biotech fell as much as 7 percent on April 9.

Roche did its best to downplay the significance of the pause in MODUL, which is evaluating a variety of biomarker-driven combinations as maintenance therapy for metastatic colorectal cancer. However, investors will have to wait for a readout expected later this half before deciding how the deaths impact the prospects for Tecentriq and/or Cotellic.

Among those watching closely for updates will be Bristol-Myers Squibb and Array BioPharma, which are conducting a Phase I/II trial of a slightly different combination involving Opdivo and MEK inhibitor binimetinib with and without Yervoy (ipilimumab).

See ViewPoints: Exelixis stumbles ahead of IMblaze readout

Orchard goes portfolio-picking

CEO Emma Walmsley’s latest move in reshaping GlaxoSmithKline involved offloading the UK drugmaker’s struggling gene therapy unit, led by ultra-rare immunodeficiency product Strimvelis, which was handed off on April 12 to a new venture-backed startup called Orchard Therapeutics.

GlaxoSmithKline is taking an equity stake in Orchard, which will absorb Strimvelis along with six other programmes (three in human testing), but is receiving little in the way of upfront payment in the deal, which is notable because Walmsley stated publicly last year that the unit was for sale. This suggests that no attractive bidders stepped up to the plate, and may be indicative of the lack of progress that the UK pharma was making with it.

Indeed, sales of Strimvelis (approved in the EU) have been meagre, and may soon be made redundant by a competing product being developed by OTL-101 from none other than Orchard.

Coincidentally, on the same day that GlaxoSmithKline was marking its exit from the gene therapy space, Pfizer announced some progress with its own efforts by initiating a Phase I trial of a gene therapy to treat Duchenne muscular dystrophy (DMD), highlighting the differences of opinion among industry behemoths about the viability of investing in rare disease research and development.

See ViewPoints: GlaxoSmithKline turns to Orchard for a gene therapy turnaround

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