Imfinzi EU approval will add to the escalating competition of PD-(L)1 inhibitors, says GlobalData

Following AstraZeneca’s announcement on 25 September 2018 that the European Commission approved its PD-L1 inhibitor, Imfinzi (durvalumab) as monotherapy for the treatment of locally-advanced, unresectable non-small cell lung cancer (NSCLC) in adults whose tumours express PD-L1 on ≥1% of tumour cells and whose disease has not progressed following platinum-based chemotherapy and radiation therapy,

Edit Kovalcsik, Managing Pharma Analyst at GlobalData, a leading data and analytics company, offers her view on the expected achievement of AstraZeneca’s PD-L1 inhibitor in NSCLC:

“The competition in the immuno-oncology checkpoint inhibitor landscape is escalating and PD-(L)1 remains one of the most popular targets. Besides Imfinzi, other monoclonal antibodies that inhibit the interaction between PD-1 and PD-L1 already on the market in the US and the EU for NSCLC include Merck’s Keytruda (pembrolizumab), Bristol Myers Squib’s Opdivo (nivolumab), and Roche’s Tecentriq (atezolizumab).

“Drug developers are pushing for approvals in as many indications and treatment settings as possible. PD-(L)1 checkpoint inhibitors are already approved in numerous other solid tumor types such as renal cell carcinoma (RCC) and head and neck squamous cell carcinoma (HNSCC), along with one blood cancers, Hodgkin’s lymphoma (HL) and hepatocellular carcinoma (HCC).

“According to GloalData’s report: ‘PharmaFocus: Visual Analysis of Immuno-Oncology Development and Opportunities’, the approved indication number for PD-(L)1 inhibitors has increased from 2015 with two in melanoma only, to 21 in Q2 2017 across all tumor types, including patients with microsatellite instability high(MSI-H)/deficient mismatch repair (dMMR) tumors. According to the report, Opdivo and Keytruda accounted for the largest number of approvals across indications in 2017.

IMAGE FOR PUBLICATION: Please click link for chart: ‘US Approval Timeline of PD-(L)1 Checkpoint Modulators to 2017′

Furthermore, a second report by GlobalData: ‘Non-Small Cell Lung Cancer (NSCLC) – Dynamic Market Forecast to 2025’, foresees that both Keytruda and Opdivo will become mega-blockbuster drugs in NSCLC, generating over 3 billion and 2 billion USD, respectively, by 2025 in the eight major markets (8MM*), while Tecentriq sales will reach 1.4 billion USD by 2025. GlobalData expects that Imfinzi will generate smaller, but substantial sales in the lucrative NSCLC market, reaching over half a billion by 2025 in the 8MM.

* 8MM: US, France, Germany, Italy, Spain, UK, Japan, China.


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Notes to Editors

Comments provided by Dr. Edit Kovalcsik, Cardiovascular and Metabolic Diseases Managing Analyst for GlobalData

Information taken from GlobalData’s PharmaFocus: Visual Analysis of Immuno-Oncology Development and Opportunities and GlobalData’s Non-Small Cell Lung Cancer (NSCLC) – Dynamic Market Forecast to 2025’,

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