AstraZeneca (AZ), sponsor for the phase 3 INTERLINK-1 trial, and Innate Pharma have announced that a planned futility interim analysis of the study sponsored did not meet a pre-determined basis for efficacy.
Having followed the recommendation of an Independent Data Monitoring Committee, AZ has told Innate that the study will end. Although there were no new safety findings identified, AZ expects to share the data in the future.
The global, multicentre, randomised, double-blind INTERLINK-1 study was sponsored by AZ. The study assessed the candidate monalizumab in combination with cetuximab compared to cetuximab in patients with recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) who have previously received treatment using platinum-based chemotherapy and PD-(L)1 inhibitors.
Commenting on the trial, Mondher Mahjoubi, chief executive officer of Innate Pharma, said: “The INTERLINK-1 phase 3 study was intended to further evaluate a novel immunotherapy regimen following the promising signals observed in a non-randomised phase 1b/2 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.”
Studies of Monalizumab will continue, with trials focusing on investigating its treatment capacity in a variety of combination strategies in different malignancies, including in the phase 3 PACIFIC-9 clinical study, sponsored by AZ, for stage 3 non-small cell lung cancer.
Susan Galbraith, executive vice president, oncology R&D, AZ, added: “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. We continue to explore the impact of monalizumab in patients with non-small cell lung cancer across different trials, including the phase 3 PACIFIC-9 trial.”
AZ obtained full oncology right to monalizumab in October 2018 by utilising its option under the co-development and commercialisation deal started in 2015.
The financial conditions of the agreement include potential cash payments up to $1.275bn to Innate.
Innate has received $450m to date, which includes a $50m payment triggered by treating the first patient in the phase 3 PACIFIC-9 clinical study.
For any commercialised cancer indication, AZ will book all sales revenue and is contracted to pay Innate low double-digit to mid-teen percentage royalties on net sales globally, except in Europe where Innate will receive 50% share of the profits and losses in the territory.