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The phase 3 INTERLINK-1 trial was discontinued after monalizumab plus cetuximab failed to meet a predefined threshold for efficacy compared with cetuximab alone in patients with recurrent or metastatic squamous cell carcinoma of the head and neck.
Monalizumab plus cetuximab (Erbitux) failed to meet a predefined threshold for efficacy compared with cetuximab alone in patients with recurrent or metastatic squamous cell carcinoma of the head and neck who received prior platinum-based chemotherapy and PD-1/PD-L1 inhibition, according to a planned futility interim analysis of the phase 3 INTERLINK-1 trial (NCT04590963).1
Based on this result and the recommendation of an Independent Data Monitoring Committee, AstraZeneca discontinued the study and will share the data in due course.
“The INTERLINK-1 phase 3 study was intended to further evaluate a novel immunotherapy regimen following the promising signals observed in a non-randomized phase 1b/2 study [NCT02643550] 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,” Mondher Mahjoubi, MD, chief executive officer of Innate Pharma, stated in a press release.
Monalizumab is a potentially first-in-class immune checkpoint inhibitor targeting NKG2A receptors, which are expressed on tumor infiltrating cytotoxic CD8+ T cells and natural killer cells.
In October 2018, Innate Pharma announced a multiterm agreement with AstraZeneca, building on an existing collaboration, geared toward accelerating each company’s oncology portfolio and bringing new treatments to patients more quickly. Under the terms of the agreement,
AstraZeneca obtained full oncology rights to monalizumab, expanding its partnership with Innate from the initial collaboration announced in 2015.2
INTERLINK-1 was a global, multicenter, randomized, double-blind phase 3 study of monalizumab and cetuximab vs placebo and cetuximab. The study was designed to enroll approximately 600 patients with recurrent or metastatic squamous cell carcinoma of the head and neck who received prior therapy with platinum-based chemotherapy and PD-1/PD-L1 inhibition.
The primary end point of the trial was overall survival (OS) in HPV-unrelated participants. Secondary end points included OS in all randomized participants, progression-free survival, overall response rate, duration of response, safety, and quality of life.
“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 [NCT03822351] and NeoCOAST [NCT03794544] studies,” Mahjoubi said. “Our focus for monalizumab remains on the phase 3 PACIFIC-9 study [NCT05221840] in the unresectable stage III non–small cell lung cancer [NSCLC] setting, as well as the phase 2 NeoCOAST-2 study [NCT05061550] in the neoadjuvant early-stage lung cancer setting.”
“We are disappointed by this outcome and what it means for patients. We would like to thank the patients, investigators and healthcare professionals who dedicated their time and expertise to this trial, which has advanced our understanding of metastatic head and neck cancer,” Susan Galbraith, executive vice president of Oncology R&D at AstraZeneca, said. “We continue to explore the impact of monalizumab in patients with NSCLC across different trials, including the phase 3 PACIFIC-9 trial.”