Friday Five – The pharma week in review (13 November 2020)

What the world was waiting for

Collaborators Pfizer and BioNTech announced on Monday that an interim analysis of Phase III data shows their investigational COVID-19 vaccine BNT162b2 is more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection.

See Physician Views: Gauging doctors' response to new COVID-19 vaccine data

The effectiveness of BNT162b2 is not only better than what was widely expected, but the interim analysis occurred after a higher than initially anticipated number of COVID-19 cases accrued in study participants, meaning the data are more statistically robust.

Experts were quick to suggest that with other vaccines in development targeting the same SARS-CoV-2 spike protein, Pfizer and BioNTech's success bodes well for the prospect of multiple COVID-19 vaccines becoming available next year.

Moderna subsequently confirmed on Wednesday that it has completed the necessary case accrual to perform a first interim analysis of its own vaccine candidate mRNA-1273, with data expected to be published in the next week or so.

Analysis

ViewPoints: Pfizer’s COVID success resets the vaccine competition

ViewPoints: It works! – Pfizer, BioNTech deliver a COVID-19 vaccine breakthrough

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Other vaccine news

Perhaps not to be outdone, the Russian Direct Investment Fund (RDIF) announced on Wednesday than interim results from the Phase III study of the Gamaleya Institute's COVID-19 vaccine Sputnik V suggest it has an efficacy rate of 92%, albeit after just 20 confirmed cases of infection were recorded among more than 16,000 trial participants who were given either a placebo or the vaccine.

Though the data are likely to be met with some scepticism, the results – if robust – could bode well for other adenovirus vector-based vaccines, such as the one being developed by the University of Oxford and AstraZeneca. Professor John Bell – the Regius Chair of Medicine at Oxford – said on Monday that he now expects a return to relative normality by spring 2021 based on the likelihood of multiple vaccines becoming available.

See also

FDA fast-tracks Novavax COVID-19 vaccine NVXCoV2373

Brazil halts study of Sinovac's COVID-19 vaccine after serious adverse event

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Antibody treatment approved in US as Biden readies new COVID-19 taskforce

Joe Biden's election success may not have been recognised by everyone, but the US President-elect has wasted no time putting together a new taskforce that will advise the incoming administration on the country's COVID-19 response.

"Dealing with the coronavirus pandemic is one of the most important battles our administration will face, and I will be informed by science and by experts," stated Biden, adding that the new advisory board will help in part "shape my approach to…ensuring vaccines are safe, effective and distributed efficiently, equitably and free." More here.

In addition to the prospect of one or more imminent vaccines, the FDA approved Eli Lilly's emergency-use authorisation (EUA) request for the investigational neutralising antibody bamlanivimab. The AbCellera-partnered therapy, also known as LY-CoV555, is authorised to treat recently diagnosed, mild-to-moderate COVID-19 in patients 12 years and older with a positive COVID-19 test, who are at high risk for progressing to severe COVID-19 and/or hospitalisation.

The FDA is also currently reviewing a EUA submission for Regeneron Pharmaceuticals' REGN-COV2, a combination of two monoclonal antibodies, in adults with mild-to-moderate COVID-19 who are at high risk for poor outcomes.

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Biogen comes down with a bump

Having been buoyed by the pre-meeting publication of positive briefing notes authored by FDA reviewers (see Friday Five – The pharma week in review (6 November 2020)), Biogen and Eisai's hopes of securing US approval for their investigational Alzheimer's disease treatment aducanumab were then dashed by a much more critical analysis by experts during a hotly-anticipated AdCom meeting last Friday.

Ultimately the advisory panel voted against approval of aducanumab, saying evidence from a single positive study is not enough to demonstrate the drug's efficacy in Alzheimer's disease in light of conflicting results from another trial. 

The panel voted 8-1 that the positive EMERGE trial could not be viewed on its own as providing strong evidence supporting the effectiveness of aducanumab, without taking into account the conflicting ENGAGE data. Two other panellists were undecided on that question. The FDA also asked the advisory committee to consider post-hoc exploratory analyses that were conducted to help "achieve maximum understanding of the partially discordant results" of both studies, along with supportive data from a small Phase I trial dubbed Study 103, and evidence of aducanumab having a pharmacodynamic effect on Alzheimer's disease pathophysiology. Specifically, they were asked whether this could justify taking the EMERGE data as "primary evidence" to support the efficacy of aducanumab, with 10 panel members voting against and one vote cast as undecided.

Analysts and investors have been left wondering if the FDA will, on this occasion, ignore the advice of the panel given how keen it appears to be to approve aducanumab, based on the positive tone of its briefing notes.

Analysis – ViewPoints: AdCom makes FDA’s job on aducanumab infinitely easier – or more difficult

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Tezepelumab delivers at the top-line; detailed results up next

AstraZeneca and Amgen announced on Tuesday that a Phase III study of the experimental therapy tezepelumab in patients with severe, uncontrolled asthma met its primary endpoint. In the NAVIGATOR trial, the monoclonal antibody, when added to standard of care, demonstrated a significant and clinically meaningful reduction in the annualised asthma exacerbation rate (AAER) over 52 weeks compared to placebo plus standard of care.

"Tezepelumab works differently from any other asthma biologic medicine," remarked Mene Pangalos, executive vice president of biopharmaceuticals R&D at AstraZeneca, with the monoclonal antibody designed to block the action of thymic stromal lymphopoietin (TSLP), an epithelial cytokine that plays a key role across the spectrum of asthma inflammation.

The companies said that in patients with baseline eosinophil counts of less than 300 cells/mcL, the study achieved its main goal of demonstrating a significant and clinically meaningful reduction in AAER. AstraZeneca and Amgen further noted that similar reductions in AAER were seen in a subgroup of patients with baseline eosinophil counts less than 150 cells/mcL. This could give tezepelumab a broader label than other available biologic therapies for severe asthma, which work by different mechanisms of action.

Analysis

ViewPoints: Asthma data produce sigh of relief at Amgen

Physician Views: Setting expectations for Amgen, AstraZeneca's tezepelumab

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