276MO - Superior single agent effectiveness with plinabulin (Plin) versus (vs) placebo (Plac) for docetaxel (Doc)-induced neutropenia (DIN) prevention in non-small cell lung cancer (NSCLC) patients (pts)

Background

Hematologic complications (HC) in NSCLC pts increase pt toxicity, inconvenience, financial toxicity, and risk for COVID-19 infection. Plin, a novel progenitor cell-protective molecule is non-inferior to Pegfilgrastim (Peg) for the prevention of DIN (Blayney, JAMA Open 2021). Plin, as a single dose per cycle, reduces healthcare touches as it is given on the same day as Chemo, has minimal bone pain and thrombopenia (TP), and has anti-cancer efficacy (Blayney, JAMA Onc 2020). Doc 75 mg/m² is typically used without G-CSF. Plin’s DIN effectiveness vs Plac (‘no G-CSF’) was evaluated in NSCLC.

Methods

NSCLC pts with at least one febrile N (FN) risk factor received Doc 75 mg/m² with Plin (20 mg/m² (or its equivalent of 40 mg fixed dose); n=30) in the Ph2/3 study PROTECTIVE-1 (NCT03102606), or without Plin (Plac; n=224) in Ph3 study DUBLIN-3(NCT02504489). Plin is a single 30-min IV infusion per cycle (C), 30 min after Doc. C1 blood sampling was pre-dose, day (D)1, 2, 6, 7, 8, 9, 10, 15, 21 with Plin, and at predose, D1, D8 with Plac; and after C1, at predose, D8. HC endpoints (N (All Grade (Gr), Gr4, Gr3/4), anemia (AN), and TP, were calculated from Covance Central Laboratory over 4 Cs. Duration of severe (Gr4) N (DSN) was calculated in C1 from actual ANC profile over time for Plin, and through modeling with Plac, using observed D8 ANC (= ANC nadir for Doc). FN, Infections, adverse events, and Quality of Life (QoL with EORTC QLQ-C30) over 4 Cs were evaluated.

Results

Baseline demographics were comparable. Plin was well tolerated. Gr4N % with Plin in C1,2,3 and 4 was 17%, 3%, 0% and 0%. QoL with Plin remained stable. Table: 276MO

*p-value is significant in favor of Plin

Conclusions

In prospective trials with NSCLC pts, Plin was superior for the prevention of DIN and HC vs Plac and had a favorable QoL and safety profile. The same-day-dosing and low AE burden with Plin minimizes healthcare touches, financial toxicity, and patient inconvenience.

Clinical trial identification

Ph3 DUBLIN-3(NCT02504489); Ph2/3 study PROTECTIVE-1 (NCT03102606).

Editorial acknowledgement

Legal entity responsible for the study

BeyondSpring Pharmaceuticals, Inc.

Funding

BeyondSpring Pharmaceuticals, Inc.

Disclosure

D. Blayney, L. Huang, G. Legaspi, S. Duprez, R. Mohanlal: Financial Interests, Personal, Principal Investigator: BeyondSpring Pharmaceuticals, Inc. S. Ogenstad: Financial Interests, Personal, Advisory Role: BeyondSpring Pharmaceuticals, Inc.