Phase 3 study of monalizumab in head and neck cancer misses efficacy mark
A phase 3 study of monalizumab among patients with squamous cell carcinoma of the head and neck will be discontinued after a futility interim analysis failed to meet a predefined threshold for efficacy, according to a press release.
Monalizumab (Innate Pharma, AstraZeneca), an immune checkpoint inhibitor that targets NKG2A receptors on CD8-positive T cells and natural killer cells, had showed promising signals in a nonrandomized phase 1b/phase 2 study among patients with head and neck cancer, Mondher Mahjoubi, CEO of Innate Pharma, said in the Innate Pharma press release.
The multicenter, randomized INTERLINK-1 study aimed to further assess the agent with either the epidermal growth factor receptor antibody cetuximab (Erbitux, Eli Lilly) or placebo among patients with recurrent or metastatic HNSCCC who previously received platinum-based chemotherapy and PD-1 or PD-L1 inhibitors.
OS among HPV-unrelated participants served as the primary endpoint, with OS among all participants, PFS, overall response rate and safety as secondary endpoints.
The study revealed no new safety findings, the press release stated.
AstraZeneca, which sponsored the study and holds full oncology rights to monalizumab, informed Innate that based on the efficacy result and an independent data monitoring committee recommendation, the study will be discontinued.
“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,” Mahjoubi said in the press release. “We remain confident in the development program for monalizumab in lung cancer, where encouraging data have been previously reported from the randomized, phase 2 COAST and Neo-COAST studies. Our focus for monalizumab remains on the phase 3 PACIFIC-9 study in 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.”
PACIFIC-9, also sponsored by AstraZeneca, is investigating the PD-L1 inhibitor durvalumab (Imfinzi, AstraZeneca) with monalizumab or the anti-CD73 antibody oleclumab (AstraZeneca) specifically among patients who did not experience NSCLC progression after platinum-based concurrent chemoradiotherapy, according to the press release.
Read more about