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BeyondSpring’s Novel Study 103 Phase 3 Design in NSCLC To Be Presented at 2019 IASLC World Conference on Lung Cancer
Study 103, a Phase 3 global multi-center clinical trial, was undertaken in stage IIIB/IV, EGFR-wild type non-small cell lung cancer (NSCLC) patients [n=554], in 2nd and 3rd line therapy with Docetaxel plus Plinabulin, or Docetaxel in a 1:1 ratio. Patients should have failed a prior line with a platinum-based regimen, and patients who had failed prior PD1/PD-L1 immunotherapy were allowed to enter the study. EGFR-wild type patients represent a severely underserved population, with a median overall survival (OS) at around 8-10 months, which is much shorter in comparison to patients with EGFR mutant, with a median OS at around 18 months. Even with PD-1/PD-L1 antibody treatment, only around 20 percent of these patients respond to treatment, leaving behind 80 percent of patients who require alternative therapies. Plinabulin is administered via 60 minutes of IV infusion and is given 1 hour after Docetaxel completion on Day 1. 450 patients have been enrolled in the study to date, and were treated with either:
Plinabulin, a marine-derived, novel small-molecule, is BeyondSpring’s lead asset that activates GEF-H1, a guanine nucleotide exchange factor. GEF-H1 activates downstream transduction pathways leading to the maturation of dendritic cells, which, in turn, leads to T-cell activation, in an antigen-specific manner. Plinabulin, combined with an antigen-generator, such as chemotherapy, facilitates antigen presentation by dendritic cells to T-cells, resulting in tumor cell killing. Antigens that can stimulate the immune system, which are also called immunogens, are more likely to induce immune cancer cell killing than antigens for which the immune system already has developed a tolerance. This type of immunogen is more likely to be found in earlier stage cancers, as opposed to more advanced cancers that have escaped immune surveillance.
Patients with a measurable lung lesion, which represent more than 70 percent of NSCLC patients, currently have very few treatment options available to them in the 2nd and 3rd line. These patients typically have a low life expectancy and consider undergoing chemotherapy with the prospect of gaining only a few more months of life. However, this is typically at the expense of their Quality of Life (QoL) due to severe toxicities and can be an unattractive option. With the Plinabulin/Docetaxel combination,
“The acceptance of this poster by the IASLC validates the novel trial design employed in Study 103. Based on the data at the first pre-planned interim analysis in n~350 patients with median OS as the primary endpoint, the DSMB concluded that the study could continue unmodified to the second pre-planned interim analysis, which is expected to be triggered later this year or early next year. If the Plinabulin/Docetaxel combination meets its target product profile of better efficacy, and with an improved safety and QoL profile than Docetaxel, the standard of care, it holds the promise of becoming the preferred 2nd and 3rd line treatment option in NSCLC, an area with significant unmet medical need, as PD1/PD-L1 immunotherapy has moved into 1st line treatment,” said Dr.
Cautionary Note Regarding Forward-Looking Statements
Source: BeyondSpring, Inc.