Friday Five – The week in review

AstraZeneca becomes a trend-setter in immuno-oncology

Having previously found itself playing catch-up to more advanced competitors in the immuno-oncology market, AstraZeneca turned trend-setter late last week by announcing positive data from the PACIFIC trial, which is assessing the PD-L1 inhibitor Imfinzi in Stage III unresectable non-small-cell lung cancer (NSCLC).

Imfinzi monotherapy, when used as maintenance treatment sequential to chemotherapy and radiotherapy, demonstrated superior progression-free survival versus standard of care irrespective of PD-L1 status, AstraZeneca announced. Positive data not only demonstrates that immuno-oncology has a place in earlier-stage, non-metastatic disease, but AstraZeneca should enjoy a multi-year monopoly in this particular indication, which could be worth between $1 billion and $2 billion in peak sales, forecast analysts. Earlier-than-expected data from the PACIFIC trial also relieves some pressure on AstraZeneca ahead of readout from the MYSTIC study, which is anticipated in the next few months. MYSTIC is assessing both Imfinzi and the combination of Imfinzi with the CTLA-4 inhibitor tremelimumab in first-line NSCLC.

ASCO abstracts drop

Immuno-oncology has also dominated initial discussion of abstracts published ahead of next month's annual ASCO meeting. Incyte was the notable winner, with shares up more than 9 percent in after-hours trading on Wednesday. Positive investor reaction came in response to promising Phase II data for the combination of Incyte's IDO inhibitor epacadostat with a PD-1 inhibitor, showing improved response rates versus PD-1 monotherapy in a number of tumour types. Incyte confirmed earlier this year that it has already chosen to progress this combination into a number of Phase III trials, under collaborations with both Merck & Co. (melanoma, bladder, non-small-cell lung, renal and head and neck cancer) and Bristol-Myers Squibb (non-small-cell lung and head and neck cancer) – ViewPoints: Incyte emerges as clear winner from ASCO abstract dump

Another abstract of note shows that updated results from Merck's Keynote-021 (Cohort G) trial demonstrate a trend towards survival benefit for the combination of Keytruda and chemotherapy, versus chemotherapy alone, in treatment-naïve NSCLC patients – ViewPoints: Merck & Co.'s Keytruda/chemo combination shown to be trending towards a survival benefit

The FDA recently expanded Keytruda's label to include use in this setting; our recent snap-poll of US oncologists suggests demonstration of an overall survival benefit will play an important role in driving utilisation of the Keytruda/chemotherapy combination – Physician Views Poll Results – Oncologists predict 'considered' use of Keytruda/chemo combo in first-line NSCLC

New migraine therapies set to enter regulatory arena

The race to bring a new class of migraine therapies to market is hotting-up. Amgen announced on Thursday it has filed the CGRP inhibitor erenumab with the FDA and recently expanded its co-marketing collaboration with Novartis to include the US market. Eli Lilly has also announced positive Phase III data for its competing product galcanezumab in both episodic and chronic migraine and hopes to file for approval in the US in the third quarter.

Expectation for multi-billion dollar peak sales for the CGRP inhibitor class remains high, despite the relatively small proportion of total migraine patients these injectable biologics will be targeted at. That said, physician feedback indicates these products show meaningful clinical effect in episodic and chronic patients.

One issue could be pricing, as although each of the CGRP candidates – there are a total of four in late-stage development – offers some form of differentiation, these may not prove definitive enough to prevent payers from playing the various candidates off against one another. Erenumab is poised to secure first-to-market status, while galcanezumab is part of a multi-faceted attempt by Eli Lilly to expand both the chronic/episodic and acute migraine markets – and is the subject of our most recent Physician Views poll – Physician Views: Do prescribers hold high hopes for Eli Lilly's one-two strategy in migraine treatment and prevention?

Johnson & Johnson confident it can ride out headwinds

Faced with the threat of biosimilar erosion to Remicade sales and the launch of generic competitors to Zytiga from 2018 onwards, Johnson & Johnson used its biannual pharmaceutical review day to remind investors that it expects strong growth from a number of existing brands over the next four-five years to be flanked by 11 new blockbuster launches from the R&D pipeline – Spotlight On: J&J uses ‘pharma review’ to outline plan to overcoming near-term patent cliff

In the same presentation, however, management appeared to concede that loss of share for its diabetes treatment Invokana could accelerate following the FDA's decision to add a black-box warning to the drug's label – ViewPoints: CANVAS data paints a less rosy picture for Johnson & Johnson's Invokana

The expert view

In addition to our Physician Views polls looking at future use of Merck's Keytruda/chemotherapy combination in NSCLC and prescriber sentiment towards Eli Lilly's emerging migraine pipeline (see above), FirstWord also polled US dermatologists this week to get a better understanding of how many patients are readily gaining access to Regeneron Pharmaceuticals and Sanofi's Dupixent for moderate-to-severe atopic dermatitis – predicted to be one of 2017's biggest new drug launches.

We have also spoken to key opinion leaders about recent approval of Mitsubishi Tanabe Pharma's Radicava for the treatment of amyotrophic lateral sclerosis and the future development landscape in this disease area, the future use of MEK/BRAF inhibitor combinations for the treatment of melanoma in a post-immunotherapy world and the commercial opportunity for Takeda's recently approved ALK inhibitor Alunbrig.

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