Abstract 1715P
Background
Due to COVID-19, the NCCN Myeloid Growth Factor Panel expanded prophylactic G-CSF use to chemotherapy with Intermediate Risk (10%-20% risk) of Febrile Neutropenia (FN), and to Low Risk FN patients (pts) who previously developed FN. Preservation of resources for COVID-19 pts by reducing hospitalizations and emergency room visits by cancer chemotherapy pts is the intent of these changed recommendations. Other recommendations include use of self-injecting or on-body injector Peg, to minimize COVID-19 exposure at outpatient center by cancer pts and limiting prophylactic platelet transfusion to preserve blood product supply. Plin is an attractive alternative: it is a novel, non-G-CSF small molecule with CIN protection comparable to Peg, is given once 30 minutes after Chemo, and avoids the need for healthcare system touches on Day 1-3 for G-CSF administration. In contrast to Peg, Plin does not cause bone pain and thrombocytopenia and maintains quality of life.
Methods
We compared the combined CIN data with single agent (SA) Plin 20 mg/m2 (n=29) vs. SA Peg 6mg (n=35) from 2 different phase II CIN studies over 4 cycles: 1. Study 105 in NSCLC pts given Intermediate FN Risk Docetaxel 75 mg/m2 (Doc) pts with risk factors), and 2. Study 106 in Breast cancer pts given High FN Risk Doc +Doxorubicin 50 mg/m2 + Cyclophosphamide 50mg/m2 (TAC). Plin was given as a single IV infusion on Day (D)1, 30 min after the last Chemo, and Peg 6mg given on D2 by SC injection. Grade 4 Neutropenia (Gr 4 N), Hospitalizations (Hosp), Infection rate (Inf), Sepsis (Sep), all Grade Thrombocytopenia (T) or Gr 2/3 T and Bone Pain (BoP) is summarized for SA Plin and SA Peg. (NS= non-significant).
Results
Table: 1715P
| Gr 4 N | Hosp | Inf | Sep | All Gr T | Gr 2/3 T | Gr 3 T | BoP | |
| Pegfilgrastim | 42.9% | 11.4% | 5.71% | 0% | 68.6% | 20% | 8.57% | Yes |
| Plinabulin | 44.8% | 13.8% | 6.90% | 3.44% | 24.1% | 3.4% | 0% | No |
| p-value | NS | NS | NS | NS | 0.0002 | 0.025 | 0.06 | - |
Conclusions
Plin requires at least 50% fewer touches to the health care system and is equally effective as Peg for prevention of CIN and its clinical sequelae. Plin causes less thrombopenia and bone pain. Plin (given as a 40 mg fixed dose) is currently in two phase III trials for CIN.
Clinical trial identification
NCT03102606, NCT03294577.
Editorial acknowledgement
Legal entity responsible for the study
BeyondSpring Pharma, Inc.
Funding
BeyondSpring Pharma, Inc.
Disclosure
D. Blayney: Research grant/Funding (institution), Travel/Accommodation/Expenses: BeyondSpring. R. Mohanlal: Leadership role, Full/Part-time employment, Officer/Board of Directors: BeyondSpring. L. Huang: Leadership role, Shareholder/Stockholder/Stock options, Officer/Board of Directors: BeyondSpring.