|View printer-friendly version|
BeyondSpring’s Single-Blinded Design (for Patients Only) of Phase 3 Study 103 (DUBLIN-3) Prevented Premature Patient Drop-Out: Data Accepted for Presentation at SITC 2019
As cancer patients generally prefer immunotherapy over chemotherapy, they may prematurely withdraw their consent to participate in a clinical trial if they are allocated to the chemotherapy comparator arm, which may negatively impact the study’s outcome. The PD-L1 inhibitor Avelumab in the open-label trial Javelin failed to meet its primary objective to demonstrate a survival benefit versus the standard of care Docetaxel comparator arm, in stage IIIB/IV NSCLC patients. One of the reasons for this negative trial outcome was the high percentage of premature drop-out rate from the Docetaxel arm (75 mg/m2), according to the Javelin study authors.
BeyondSpring’s single-blinded (for patients only) Phase 3 Study 103 (
The data showed that the single-blinded design employed in
"The results from this analysis validate the effectiveness of a single-blinded (for patients only) study design for the prevention of premature patient drop-out from the chemotherapy comparator arm. Since premature patient drop out in the comparator arm is associated with negative trial outcome results, these observations may prove favorable in obtaining a positive outcome in
BeyondSpring’s global Phase 3 Study 103 trial evaluates EGFR wild-type patients (target n=554) stratified for region (
In Phase 2 trials in NSCLC stage IIIB/IV patients with a measurable lung lesion in the lung, Plinabulin added to Docetaxel had a survival improvement of 4.6 months over Docetaxel alone (data presented at ASCO-SITC 2017) and also prevented Docetaxel-induced Neutropenia (data presented at ASH 2017, 2018), and improved QoL in NSCLC patients receiving Docetaxel (data presented at
Since Docetaxel is the current standard of care in second- and third-line in stage IIIB/IV NSCLC, the addition of Plinabulin to Docetaxel has the potential to become the new standard of care in second- and third-line stage IIIB/IV NSCLC if the Phase 3 data confirms the Phase 2 data by showing superior efficacy, superior safety and superior QoL compared to Docetaxel monotherapy.
Cautionary Note Regarding Forward-Looking Statements
Source: BeyondSpring, Inc.