In the Western world, the first gene therapy in oncology was approved in 2015, when both European Medicines Agency (EMA) and FDA approved Amgen’s Imlygic (talimogene laherparepvec). Imlygic is a genetically modified oncolytic viral therapy that is designed to replicate within tumours and produce an immunostimulatory protein called granulocyte-macrophage colony-stimulating factor (GM-CSF).

Upon intratumoral (IT) administration, Imlygic causes tumour cell lysis and ruptures tumours, releasing tumour-derived antigens, which is thought to amplify an anti-tumour immune response in combination with GM-CSF. Despite the initial hype for this exciting mode of cancer gene therapy, Imlygic’s debut did not translate into sustained growth in the melanoma market, with Amgen’s global revenues for both Imlygic and Corlanor (ivabradine), combined with its two business operations, reached a mere $63M in Q1 2018.

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

GlobalData believes that the limitations of the IT administration and the intense competition from immune checkpoint inhibitors (CPIs) due to their efficacy and manageable side effects are the two main factors that underlie the negligible revenue of this novel therapy, which is otherwise an efficacious and highly tolerable treatment option in melanoma.

Limitations of IT administration

While IT injection may appear to be a convenient way of administering a therapy, it often entails the injection of numerous lesions and requires multiple injections per lesion to generate a clinical benefit, which collectively results in a cumbersome treatment regimen compared to intravenously administered treatment options such as CPIs in melanoma.

In addition, IT administration is most applicable to cutaneous and subcutaneous tumours, which results in local tumour responses but often falls short of leading to a systemic clinical benefit due to insufficient delivery of the therapy to visceral lesions. Consequently, disease progression in visceral lesions is one of the major reasons of treatment failure following IT administration of Imlygic.

See Also:

Having fallen behind CPIs as a monotherapy, Amgen’s new strategy is to join forces with CPIs to bring Imlygic to prominence in melanoma and other oncology indications. In a Phase Ib/II clinical trial, when given in combination with Bristol-Myers Squibb’s Yervoy (ipilimumab), Imlygic was found to be superior to Yervoy monotherapy, doubling the objective tumour response rate in unresectable advanced melanoma.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

In the ongoing Phase III KEYNOTE-034 study, Imlygic is being paired with Merck & Co.’s anti-programmed cell death protein 1 (anti-PD-1) CPI Keytruda (pembrolizumab) in unresected melanoma. If the results from this study, which are expected in Q4 2018, are positive, they could help Imlygic to move to the forefront of the treatment algorithm and help Amgen carve out a considerable market share in melanoma.

For more insight and data, visit the GlobalData Report Store – Pharmaceutical Technology is part of GlobalData Plc.

Cell & Gene Therapy Coverage on Pharmaceutical Technology supported by Cytiva.

Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content.