At the recent European Society for Medical Oncology Congress, BeyondSpring Pharmaceuticals (NASDAQ:BYSI) presented its novel study design for DUBLIN-3, a global Phase 3 trial assessing plinabulin in non-small cell lung cancer (NSCLC) patients.
DUBLIN-3 is a single-blinded study of 554 NSCLC patients stratified for region (Asia / non-Asia) and receiving second- or third-line therapy with either a docetaxel-plinabulin combination or docetaxel alone. The patients have at least one measurable lung lesion, which correlates with a higher probability that their tumors are still immunogenic. The primary endpoint is overall survival.
DUBLIN-3 is designed based on lessons learned from the comparative Phase 3 JAVELIN Lung 200 study, where avelumab was compared with docetaxel in NSCLC patients. BeyondSpring believes that this study’s lack of patient blinding and stratification for region, and inclusion of patients with tumors less likely to be immunogenic, may have played a role in the trial’s negative outcome.
“When going up against docetaxel – an established, highly effective treatment for second- and third-line NSCLC – for a comparison trial, avelumab may have failed due to critical trial design considerations, which were avoided with the design of DUBLIN-3,” Dr. Ramon Mohanlal, BeyondSpring’s EVP of R&D, and CMO, said in a statement.
“If the plinabulin/docetaxel combination meets its intended target product profile of superior survival benefit, superior safety and quality-of-life compared to docetaxel alone, it has the potential to become the preferred second- and third-line treatment option in NSCLC,” he added.
In the first quarter of 2019, the Company reached the first pre-specified interim analysis and the data and safety monitoring board recommended that the trial continue. The second interim analysis is expected in the first quarter of 2020, and if pre-specified statistics are met, the trial could be concluded.
