1587TiPCANOPY phase III program: Three studies evaluating canakinumab in patients with non-small cell lung cancer (NSCLC)

AbstractBackgroundThe presence of inflammatory mediators in the tumor microenvironment may have pro or antitumorigenic effects. The cytokine interleukin-1 β (IL-1β) affects multiple aspects of the tumor microenvironment promoting carcinogenesis, tumor invasiveness, and immunosuppression. Canakinumab is a human monoclonal antibody with high affinity and specificity for IL-1β. Results of the phase III Canakinumab Anti-Inflammatory Thrombosis Outcomes Study (CANTOS) have shown that IL-1β inhibition with canakinumab was associated with reduced lung cancer incidence and mortality, providing a rationale to investigate the possible therapeutic role of canakinumab in lung cancer.Trial designDetails of the three phase III trials designed in parallel to evaluate canakinumab in NSCLC are provided in the table below Table:1587TiP Overview of CANOPY programCANOPY-A (NCT03447769)CANOPY-1 (NCT03631199)CANOPY-2 (NCT03626545)Study designProspective, multicenter, randomized, double-blind, controlledSub-study: NSCLC patients (pts) who are candidates for complete resection surgery will be asked to participate in a biomarker sub-study to understand how resection surgery may impact hsCRP, other cytokines, and additional biomarker levels in bloodTwo parts: part 1 (open-label, safety run-in) and part 2 (randomized, placebo-controlled)Population**Stages IIA –IIIA and IIIB (T >  5 cm N2), completely resected, any histologyStage IIIB/IIIC–IV, squamous or nonsquamous, treatment naïve, ...
Source: Annals of Oncology - Category: Cancer & Oncology Source Type: research