PACIFIC-9: Phase III trial of durvalumab + oleclumab or monalizumab in unresectable stage III non-small-cell lung cancer

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Authors: Fabrice Barlesi ; Byoung Chul Cho ; Sarah B Goldberg ; Kiyotaka Yoh ; Ana Caroline Zimmer Gelatti ; Helen Mann ; Aarthi Gopinathan ; Zofia Felicja Bielecka ; Michael Newton ; Charu Aggarwal

MeSH: Antibodies, Monoclonal* / administration & dosage ; Antibodies, Monoclonal* / therapeutic use ; Antibodies, Monoclonal, Humanized / administration & dosage ; Antibodies, Monoclonal, Humanized / therapeutic use ; Antineoplastic Combined Chemotherapy Protocols* / adverse effects ; Antineoplastic Combined Chemotherapy Protocols* / therapeutic use ; Carcinoma, Non-Small-Cell Lung* / drug therapy ; Carcinoma, Non-Small-Cell Lung* / pathology ; Chemoradiotherapy / methods ; Clinical Trials, Phase III as Topic ; Double-Blind Method ; Humans ; Lung Neoplasms* / drug therapy ; Lung Neoplasms* / pathology ; Multicenter Studies as Topic ; Neoplasm Staging* ; Randomized Controlled Trials as Topic

Keywords: CD73 ; NKG2A ; chemoradiotherapy ; durvalumab ; immune checkpoint inhibitor ; lung cancer ; monalizumab ; monoclonal antibody ; oleclumab ; programmed cell death ligand-1

Abstract: Evidence from the Phase III PACIFIC trial established durvalumab, a monoclonal antibody (mAb) targeting PD-L1, following concurrent chemoradiotherapy (cCRT) as a global standard of care for patients with unresectable, stage III non-small-cell lung cancer (NSCLC). There remains an unmet need to improve upon the outcomes achieved with the PACIFIC regimen. Combining durvalumab with other immunotherapies may improve outcomes further. Two such immunotherapies include oleclumab, an mAb targeting CD73, and monalizumab, an mAb targeting NKG2A. Both agents demonstrated antitumor activity in early-phase trials. PACIFIC-9 (NCT05221840) is an international, double-blind, randomized, placebo-controlled, Phase III trial comparing durvalumab plus either oleclumab or monalizumab with durvalumab plus placebo in patients with unresectable, stage III NSCLC and no disease progression following cCRT.Clinical Trial Registration: NCT05221840 (ClinicalTrials.gov).