Update on AstraZeneca-sponsored INTERLINK-1 phase III study of monalizumab + cetuximab for metastatic squamous cell carcinoma of the head and neck

Based on this 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.

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 (R/M SCCHN) who have been previously treated with platinum-based chemotherapy and PD-(L)1 inhibitors.

“The INTERLINK-1 Phase III study was intended to further evaluate a novel immunotherapy regimen following the promising signals observed in a non-randomized Phase 1b/II study of head and neck cancer. While we are disappointed with the outcome of this study, the findings are certain to advance our understanding of the role of immunotherapy in this setting,” said Mondher Mahjoubi, Chief Executive Officer of Innate Pharma. “We remain confident in the development program for monalizumab in lung cancer, where encouraging data has been previously reported from the randomized, Phase II COAST and Neo-COAST studies. Our focus for monalizumab remains on the Phase III PACIFIC-9 study in the unresectable Stage III non-small cell lung cancer setting, as well as the Phase II NeoCOAST-2 study in the neoadjuvant early-stage lung cancer setting.”

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. It is being studied in a Phase III clinical study sponsored by AstraZeneca, PACIFIC-9, evaluating durvalumab (PD-L1) in combination with monalizumab or AstraZeneca’s oleclumab (anti-CD73) in patients with unresectable, Stage III non-small cell lung cancer (NSCLC) who have not progressed following definitive platinum-based concurrent chemoradiation therapy.