BeyondSpring Inc. announced that the company has met the primary objective in the Phase 2 portion of its global Phase 2/3 clinical trial (Study 105) for the prevention of CIN with docetaxel, comparing BeyondSpring’s lead asset, Plinabulin to pegfilgrastim (Neulasta), a long-lasting G-CSF, and will soon begin the Phase 3 portion of Study 105. Initial data from the Phase 2 portion of Study 105 will be presented at the 2018 ASCO-SITC Clinical Immuno-Oncology Symposium in San Francisco on Jan. 25-27, 2018. In addition, the company announced that a p value of <0.0001 from its ongoing Phase 3 NSCLC clinical trial (Study 103) was achieved from 138 patients on a secondary endpoint of grade 4 neutropenia, which demonstrates Plinabulin’s ability to reduce docetaxel CIN. This data review does not subject the study to a statistical penalty. Interim anti-cancer efficacy data from Study 103 is expected in mid-2018. In Study 105, Plinabulin meets the primary objective of the recommended Phase 3 dose selection. Patients with NSCLC were randomized to arm 1 (docetaxel + pegfilgrastim (G-CSF)), arm 2 (docetaxel + Plinabulin 5 mg/m2), arm 3 (docetaxel +Plinabulin 10 mg/m2;), or arm 4 (docetaxel + Plinabulin 20 mg/m2); Pegfilgrastim was given as a single dose, 24 hours after docetaxel use, while Plinabulin was given on Day 1, 0.5-1 hour after docetaxel use. The docetaxel dose was 75 mg/m2 in all patients; and The primary endpoint, DSN in the first treatment cycle (duration of severe /grade 4 neutropenia), is defined as the number of days that a patient experiences grade 4 neutropenia, or a neutrophil count < 0.5 x 109 cells/L from a blood draw. In Study 103, data from 138 patients demonstrate that Plinabulin reduced the percentage of patients with grade 4 neutropenia resulting from docetaxel therapy from 27.4% to 3.1% (p<0.0001). Study 103 includes NSCLC patients randomized to Plinabulin+docetaxel (n=277) or docetaxel (n=277). The primary endpoint is overall survival, and secondary endpoints include grade 4 neutropenia on Day 8 of cycle 1 (C1D8); Plinabulin (30 mg/m2) was dosed at Day 1 and 8 of each cycle. The neutrophil count from a blood draw was measured on C1D8 before the D8 dose of Plinabulin, thus showing effects after one dose of Plinabulin. The docetaxel dose was 75 mg/m2 in all patients; and Grade 4 neutropenia on C1D8 is defined as a neutrophil count < 0.5 x 109 cells/L from a blood draw. The grade 4 neutropenia rate is defined as the percentage of patients experiencing a neutrophil count below 0.5 x 109 cells/L on C1D8. As a common side effect of chemotherapy in cancer patients, neutropenia is the lack of, or severe reduction in, the number of a type of white blood cell (neutrophil) that is a key component of the innate immune system. Neutrophils are a patient’s first line of defense against infections, and patients with severe (grade 4) neutropenia (an abnormally low concentration of neutrophils in the blood) are more susceptible to severe bacterial, viral and fungal infections and sepsis, which require hospitalization and have a high mortality risk of 9 to 18% in the first cycle.