LONDON (dpa-AFX) - Innate Pharma SA (IPH, IPHYF.PK) announced Monday that a planned futility interim analysis of the INTERLINK-1 Phase 3 study sponsored by AstraZeneca (AZN, AZN.L) did not meet a pre-defined threshold for efficacy.
Based on the result and the recommendation of an Independent Data Monitoring Committee, AstraZeneca has informed Innate that the study will be discontinued. There were no new safety findings.
AstraZeneca plan to share the data in due course.
Monalizumab, Innate's lead partnered asset, is a potentially first-in-class immune checkpoint inhibitor targeting NKG2A receptors expressed on tumor infiltrating cytotoxic CD8+ T cells and NK cells.
In October 2018, AstraZeneca obtained full oncology rights to monalizumab by exercising its option under the co-development and commercialization agreement initiated in 2015.
The INTERLINK-1 study, sponsored by AstraZeneca, evaluated monalizumab in combination with cetuximab vs. cetuximab in patients with recurrent or metastatic squamous cell carcinoma of the head and neck or R/M SCCHN who have been previously treated with platinum-based chemotherapy and PD-(L)1 inhibitors.
Mondher Mahjoubi, Chief Executive Officer of Innate Pharma, said, 'We remain confident in the development program for monalizumab in lung cancer, where encouraging data has been previously reported from the randomized, Phase 2 COAST and Neo-COAST studies. Our focus for monalizumab remains on the Phase 3 PACIFIC-9 studyin the unresectable Stage III non-small cell lung cancer setting, as well as the Phase 2 NeoCOAST-2 study in the neoadjuvant early-stage lung cancer setting.'
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