Plinabulin is a novel small molecule that alters the tumor micro-environment and induces dendritic cell maturation and T-cell activation. When combined with Docetaxel, Plinabulin improved median survival of 4.6 months, compared to treatment with Docetaxel alone, in a large mechanism-based subset (72 percent of the ITT population) of non-small cell lung cancer (NSCLC) patients with a measurable lung lesion. Importantly, Plinabulin also mitigated the Docetaxel-induced severe Neutropenia, a common and potentially life-threatening adverse effect of Docetaxel.
"Plinabulin has now been administered to around 200 patients with cancer worldwide and demonstrated a favorable overall safety profile, with a very encouraging efficacy profile in NSCLC patients specifically," said Dr. Bazhenova. "Plinabulin has a well-defined mechanism of action, with immune-enhancing effects, and direct anti-tumor and vascular disrupting effects, which collectively offer a novel approach, with potentially broad utility in oncology indications. Based on the encouraging data in NSCLC patients with a measurable lung lesion (resist 1.1), a global Phase 3 trial has been initiated. Currently, over 40 patients have been enrolled, and we project to have all 550 patients enrolled by early 2018, when interim data analysis will happen."
"The findings that are being presented at IASLC are highly encouraging, as the data highlights Plinabulin's efficacy in treating measurable lung lesions and its profound impact on Neutropenia prevention," added Dr. Ramon Mohanlal, BeyondSpring Chief Medical Officer. "In addition to the Phase 3 NSCLC trial, our team has now initiated the preparation of a Phase 2/3 trial for Neutropenia prevention, with the enrollment of the first patient expected shortly."
"Patients all over the world are in need of a highly effective, affordable and convenient treatment option for both NSCLC and Neutropenia prevention, and BeyondSpring's work is bringing us one step closer to making this a reality," concluded Dr. Lan Huang, BeyondSpring CEO. "Based on the robust prior Phase 2 results, Plinabulin is in two registrational trial programs with a near-term upside. We look forward to continuing our work to bring new and innovative cancer treatments to market as quickly and efficiently as possible."
Following the results of two independent animal studies that demonstrate efficacy synergy between Plinabulin and checkpoint inhibitors, BeyondSpring also has a Phase 1/2 trial underway for Plinabulin in combination with Nivolumab for NSCLC.
The 17th Annual Targeted Therapies of the Treatment of Lung Cancer will take place on February 22 through 25, 2017. BeyondSpring's global Phase 3 NSCLC trial in patients with a measurable lung lesion is also actively recruiting in the U.S.
About BeyondSpring Pharmaceuticals
BeyondSpring is a global clinical stage biopharmaceutical company developing innovative immuno-oncology cancer therapies with a robust pipeline from internal development and from collaboration with Fred Hutchinson Cancer Research Center and University of Washington. BeyondSpring has advanced its lead asset, Plinabulin, into a Phase 3 clinical trial as a direct anticancer agent in non-small cell lung cancer. The Company is also beginning a Phase 2/3 clinical trial for Plinabulin in the prevention of chemotherapy-induced Neutropenia. BeyondSpring's experienced management team brought a combined 30+ drugs to market.
Plinabulin is an innovative small molecule agent that has multiple mechanisms of action, with an immune-enhancing mechanism, tumor vasculature targeting and activating JNK pathway to induce cancer cell apoptosis.
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KCSA Strategic Communications
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SOURCE BeyondSpring Pharmaceuticals