CT scan showing a cancerous tumour in the left lung. Credit: Lange123 at German Wikipedia.

Janssen Biotech has commenced a Phase lb trial designed to investigate the safety and efficacy of ADU-214 (JNJ-64041757) in combination with nivolumab to treat advanced lung cancer.

The trial is the result of an agreement signed between Janssen and the developer of ADU-214 Aduro Biotech in 2014. The deal has granted an exclusive, worldwide licence to Janssen for the further development of ADU-214.

The Phase lb, open-label, multi-centre trial aims to enrol 170 patients with mesothelin-positive, relapsed / refractory Stage IIIB or Stage IV adenocarcinoma of the lung.

Its primary endpoint is the percentage of participants with an objective response, which will be based on assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST); CR defined as disappearance of all target lesions.

“The Phase lb, open-label, multi-centre trial aims to enrol 170 patients with mesothelin-positive, relapsed / refractory Stage IIIB or Stage IV adenocarcinoma of the lung.”

The trial’s secondary endpoints include the percentage of participants with disease control (DC), duration of objective response (DOR), progression-free survival (PFS), overall survival (OS) and others.

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Aduro Biotech chairman, president and CEO Stephen Isaacs said: “Based on single agent data from a Phase l dose-escalation study in patients with advanced-stage relapsed or refractory non-small cell lung presented at the 2017 International Association for the Study of Lung Cancer’s World Conference, Janssen made the decision to advance ADU-214 in combination with an anti-PD-1 checkpoint inhibitor.

“The initial data demonstrated that five out of nine patients treated with single agent ADU-214 achieved a best response of stable disease, with one patient having received 25 cycles of treatment at the time of data cut off.”

Aduro Biotech aims to complete the trial by 2022.

ADU-214 is an immunotherapy developed using Aduro’s live, attenuated, double-deleted Listeria (LADD) technology platform, while nivolumab is a PD-1 immune checkpoint inhibitor developed by Bristol-Myers Squibb.