Background: Plin has clinical anticancer activity in combination with Tax (Mohanlal ASCO-SITC 2017,18). Plin prevented Tax-induced neutropenia in a post-hoc analysis of a φ 2 trial (Blayney ASH 2016). Plin is being studied in the prevention of chemotherapy(chemo)-induced neutropenia (CIN) induced by Tax/ adriamycin/ cyclophosphamide in BC, by gemcitabine/ abraxane in PC, by carboplatin/ pemetrexed/ pembrolizumab in NSCLC , and irinotecan in CRC. We report final results of the φ 2 portion of a prospective φ 2/3 trial of Plin for CIN compared with Peg (NCT03102606; Study BPI-2358-105). The 105 study is designed to demonstrate non-inferiority (NI) of Plin vs Peg for duration of severe neutropenia (DSN) in φ 3. Methods: Patients (Pts; n = 55) with lung cancer (NSCLC) were randomized to Tax 75 mg/ m2 day (D)1, and either Peg 6 mg D2 or Plin 5, 10, or 20 mg/ m2 D1. Plin was dosed on the same day of (30 min after) chemo. Absolute Neutrophil Count (ANC) was collected D1,2,3,6,7,8,9,10,15 and 21. Primary endpoints were DSN and grade (Gr) 4 neutropenia to establish recommended phase 3 dose (RP3D). The NI margin for DSN is 0.65 D. Hypertension (HT) was evaluated by semi-continuous BP measurement on D1. Results: DSN for Peg was 0.51 D and for Plin 0.54 D. Gr 3 HT was transient and not different among all groups (p < 0.18). Bone Pain occurred in 33% of pts with Peg and 11% with 20 mg/ m2 Plin. Clinical trial information: NCT03102606Conclusions: Plin 20 mg/ m2, given 30 min after chemo is well tolerated, has less bone pain, and has similar myeloprotective effect vs Peg. Its post chemo recovery curve is shallower, broader and later than Peg, with median ANC staying within normal range, suggesting a different MoA to prevent CIN. Plin 20 mg/m2 is the RP3D based upon its protection against Gr 4 neutropenia and safety profile.

* Normal range of ANC: 1.8 to 7.7 X 10^9 cells/L