NEW YORK, Feb. 21, 2017 /PRNewswire/ -- BeyondSpring Pharmaceuticals, a clinical stage biopharmaceutical company focused on the development of innovative immuno-oncology cancer therapies, today announced that the Company's clinically and statistically significant data from its Phase 2 trial of BeyondSpring's innovative lead asset, Plinabulin, for the treatment of non-small cell lung cancer (NSCLC) with Docetaxel has been selected for oral presentation at this year's ASCO-SITC Clinical Immuno-Oncology Symposium in Orlando, Fla.
Dr. Alain Mita, M.D., Associate Professor of Medicine and Co-Director, Experimental Therapeutics, at the Samuel Oschin Comprehensive Cancer Institute, Cedars-Sinai Medical Center, will present the findings during Oral Abstract Session A on February 23, 2017, at 1 p.m. ET at the Hyatt Regency Orlando.
The Phase 2 data shows that, in NSCLC patients with a measurable lung lesion, the combination of Plinabulin with Docetaxel increases median overall survival by 4.6 months, versus treating with Docetaxel alone. The addition of Plinabulin to Docetaxel also shows a statistically significant improvement in duration of response, which is indicative of Plinabulin's immune effects, versus Docetaxel alone (P<0.05). The addition of Plinabulin to Docetaxel also mitigates the known Docetaxel-related safety concerns, such as Neutropenia, without increasing immune-related adverse events.
"The Phase 2 data with Plinabulin in combination with Docetaxel is very encouraging and provides a strong justification for the global Phase 3 trial with the Plinabulin-Docetaxel combination in patients with at least one measurable NSCLC lesion, which is now underway globally," said Dr. Mita.
"Plinabulin is targeting critical steps in the immune-cascade, independent from that of PD-1 / PD-L1 intervention," added Dr. Ramon Mohanlal, BeyondSpring Chief Medical Officer. "Published data shows that Docetaxel monotherapy has a slight advantage over PD-1 inhibitors in PD-L1-negative NSCLC patients. Given the safety concerns with Docetaxel, such as Neutropenia, adding Plinabulin to Docetaxel not only improves overall efficacy but also mitigates Docetaxel-induced Neutropenia. The Plinabulin-Docetaxel combination may represent a highly effective, safe and cost-effective alternative to Nivolumab, in particular with PD-L1-negative NSCLC."
"This new data represents an important milestone for BeyondSpring, because it demonstrates Plinabulin's continued effectiveness at treating NSCLC and its potential to revolutionize cancer treatment as we know it today for patients in need all over the world," concluded Dr. Lan Huang, BeyondSpring CEO. "Combined with Plinabulin's equally high potential to be an efficient, cost-effective treatment for Neutropenia prevention, BeyondSpring is making significant strides with Plinabulin overall, pushing forward with our goal to set the standard when it comes to innovative cancer treatments in the months and years to come."
The 2017 ASCO-SITC Clinical Immuno-Oncology Symposium will take place on February 23 through 25. 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 planning 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 and tumor vasculature targeting and activating JNK pathway to induce cancer cell apoptosis.
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