Open-label, randomized multicenter phase II clinical trial of a toll-like receptor-2 (TLR2) agonist mycobacterium w (Cadi-05) in combination with paclitaxel plus cisplatin versus paclitaxel plus cisplatin in advanced non-small cell lung cancer (NSCLC)
PubMed | PA; Cadila Pharmaceuticals Ltd.
Type: Journal Article | Journal: Journal of clinical oncology : official journal of the American Society of Clinical Oncology | Year: 2016
7501 Background: TLR2 agonist, mycobacterium w (Cadi-05), a non-specific immunomodulator and pure Th 1 response enhancer has demonstrated synergistic effects with a number of chemotherapeutic agents. A phase II randomized study was conducted to test the efficacy of the combination of paclitaxel plus cisplatin with or without Cadi-05 as first line treatment of advanced NSCLC.Two hundred and twenty-one treatment nave patients (pts) with stage IIIB and IV NSCLC were randomized to receive paclitaxel 175mg/mOne hundred twelve pts were randomized to the control arm and 109 pts to the Cadi-05 arm. Pt demographics were balanced in both the arms. The RR was 36% in the control arm and 47 Cadi-05 arm. There were three complete responses all in the Cadi-05 arm. Median PFS was 157 days in control arm and was improved by 96 days to 253 days in the Cadi-05 arm [p=0.0446; HR 0.43 (95% CI 0.25-0.73)]. Median OS was 236 days in control arm and was improved by 59 days to 295 days in the Cadi-05 arm [p=0.0034;HR 0.55(95% CI 0.37-0.82)]. There were no significant differences in the adverse events in the control arm vs. the Cadi-05 arm.Addition of Cadi-05 to paclitaxel plus cisplatin in patients with advanced NSCLC is safe and results in both improvement in PFS and OS. The study is supported by Cadila Pharmaceuticals Ltd and is being presented on behalf of the Cadi-05 investigators study group.