Friday Five – The pharma week in review (5 June 2020)

AstraZeneca was ASCO's biggest winner

Results from the ADAURA study evaluating Tagrisso in pre-metastatic EGFRm non-small-cell lung cancer (NSCLC) are widely expected to be practice changing and represent a potential multi-billion dollar opportunity, despite the caveat that overall survival data has not matured.

Impressive data were also presented for the antibody-drug conjugate (ADC) Enhertu in HER2-positive lung, gastric and colorectal cancer, further validating the cost paid by AstraZeneca to in-license this asset from Daiichi Sankyo just over a year ago.

In December, Enhertu was approved in the US market for the third-line treatment of HER2-positive breast cancer, with studies under way evaluating its use in earlier-stage patients.


FirstWord Pharma PLUS users can watch our ASCO video review here


Provisional progress for Roche's anti-TIGIT

Roche presented updated Phase II results at the ASCO annual meeting strongly suggesting that its TIGIT inhibitor tiragolumab will emerge as the first product in a new class of cancer immunotherapy agents, assuming that subsequent pivotal-stage data are equally compelling.

In the CITYSCAPE study, Roche evaluated the combination of tiragolumab and its PD-L1 inhibitor Tecentriq versus Tecentriq alone in first-line metastatic NSCLC patients, earning plaudits for delivering positive data from a randomised trial.

ViewPoints: Roche's tiragolumab – hope or hype?

Caveats apply; enhanced efficacy for the tiragolumab/Tecentriq combination was driven by patients with high levels of PD-L1 expression, thereby potentially limiting the application of TIGIT inhibitors, and the Tecentriq-monotherapy control arm did not perform as strongly as anticipated. The upshot, argue some observers, is that whilst these data are encouraging we need to wait for Phase III results to read out.

KOL Views Results: Leading oncologist says so far so good for Roche’s TIGIT while identifying potential backdoor for Opdivo/Yervoy in 1L NSCLC

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CAR-T updates impress at ASCO

Competition in the multiple myeloma market will intensify over the next one to two years, with a number of new agents expected to be launched; among them two CAR-T therapies targeting BCMA being developed under partnerships between Bristol Myers Squibb and bluebird bio (bb2121), and Johnson & Johnson and Legend Biotech (JNJ-4528). At ASCO this weekend, more positive data were presented for the latter, suggesting it could potentially emerge with best-in-class efficacy and a safety profile possibly facilitating use in the out-patient setting.

Elsewhere, Allogene presented early-stage data for its allogeneic - or 'off the shelf' – CAR-T product ALLO-501, which showed broadly comparable efficacy data with autologous CD-19 targeting CAR-T products marketed by Novartis and Gilead Sciences.    

The next hurdle is durability, where allogeneic therapies have not yet shown that their responses have the same longevity as autologous versions, and lower rates of T-cell persistence remain a concern. Early data from ALLO-501 are promising, but not conclusive.

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Pfizer hit by Ibrance setback

Pfizer delivered an update to disappoint investor late last week, by confirming that its breast cancer treatment Ibrance – approved for advanced or metastatic disease – is no longer expected to succeed in the ongoing PALLAS study evaluating use in earlier-stage patients.

Share price reaction to the news illustrates the importance of Ibrance to Pfizer's growth outlook, with a number of analysts responding by cutting their peak annual sales for the drug by billions of dollars.

Rival CDK4/6 inhibitors marketed by Eli Lilly and Novartis have gained minimal market share in the metastatic setting, though focus will now shift onto whether these agents can deliver positive data in earlier-stage patients where Ibrance couldn't.

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COVID-19 round-up

Eli Lilly confirmed that the first patients have been dosed in a Phase I trial investigating the experimental antibody LY-CoV555 (under development in partnership with AbCellera) for the treatment of COVID-19. The company noted that this is the world's first study of a potential antibody treatment designed to fight COVID-19.

Despite the publication of more data showing that Gilead's remdesivir provides only modest benefits for the treatment of COVID-19, one Wall Street analyst has projected the antiviral will generate peak sales of $7.7 billion in 2022.

The World Health Organization (WHO) has said it will continue evaluating hydroxychloroquine as a potential COVID-19 treatment in its international Solidarity Trial, after a data safety monitoring board decided there was no reason to discontinue the study following a review of available data on the drug. However, a separate study has shown hydroxychloroquine to be ineffective as a prophylactic treatment for COVID-19.

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