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BeyondSpring Presents Novel Trial Design for DUBLIN-3 Study BPI-2358-103 at ESMO Congress 2019
The PD-L1 inhibitors Avelumab and Atezolizumab have demonstrated proven clinical anticancer efficacy. In second- and third-line non-small cell lung cancer (NSCLC) trials, however, Avelumab (Javelin Lung 200) failed, whereas Atezolizumab (OAK) met its primary endpoint and showed better overall survival versus Docetaxel as a comparator at 75 mg/m2. The Javelin authors pointed out that study design considerations may have led to the negative trial outcome, such as its open-label design (which led to more Docetaxel patients dropping out prior to receiving their first dose) and lack of stratification for region (Asian patients tend to respond better to Docetaxel than non-Asians). In addition, relatively low immunogenicity associated with later-stage tumors in patients may have played a role in the negative outcome of the trial.
In contrast, BeyondSpring’s global Phase 3 DUBLIN-3 trial, Study 103 is a single-blinded study in EGFR wild-type, stage IIIb/IV NSCLC patients (n=554) stratified for region (
Both Javelin and
“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
Cautionary Note Regarding Forward-Looking Statements
Source: BeyondSpring, Inc.