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Poster Display session 1

1426 - The Effect of Increasing Doses of Pegfilgrastim (Peg) on Thrombocytopenia (T) in Breast Cancer (BC) Patients (pts) Receiving Taxotere (Doc), Doxorubicin, Cyclophosphamide (TAC) and Plinabulin (Plin)

Date

28 Sep 2019

Session

Poster Display session 1

Topics

Supportive Care and Symptom Management

Tumour Site

Breast Cancer

Presenters

Douglas Blayney

Citation

Annals of Oncology (2019) 30 (suppl_5): v718-v746. 10.1093/annonc/mdz265

Authors

D.W. Blayney1, I. Bondarenko2, Y. Shi3, S. Ogenstad4, L. Du5, L. Huang6, R. Mohanlal7

Author affiliations

  • 1 Oncology, Stanford Cancer Institute, 94304 - Stanford/US
  • 2 Oncology And Medical Radiology Department, Dnipropetrovsk city multidisciplinary clinical hospital №4, 49000 - Dnipro/UA
  • 3 Oncology, Cancer Hospital Chinese Academy of Medical Sciences, 1000021 - Beijing/CN
  • 4 Medicine (oncology), Statogen Consulting, LLC, 27709 - Zebulon/US
  • 5 Clinical Operation, Wanchun Bulin Pharmaceuticals Limited, 116620 - Dalian/CN
  • 6 Clinical Operation, BeyonsSpring Pharmaceuticals, Inc, 10005 - New York/US
  • 7 Clinical Operation, BeyondSpring Pharmaceuticals, 10005 - New York/US

Resources

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Abstract 1426

Background

Plin is a novel non-G-CSF small molecule, in development for the prevention of Chemo-Induced Neutropenia (CIN) and is differentiated from Peg: Plin has anticancer activity, does not cause bone pain or an immune-suppressive Neutrophil profile (i.e NLR>5; Blayney ASC0 2018, ESMO 2018, SITC 2018). For Intermediate (10-20%) Risk for Febrile Neutropenia (FN) induced by Doc 75mg/m2, single agent (SA) Plin alone was equally effective vs SA Peg standard dose (6mg) for CIN. For High (> 20%) Risk FN induced by TAC, the combination of Plin with Peg 6mg was superior vs SA Peg 6mg, and Plin combined with half-dose Peg (3 mg) was non-inferior, with respect to CIN (Blayney ASCO 2019; St Gallen 2019). Adding Plin to any dose of Peg eradicated Peg-induced bone pain (Blayney St Gallen 2019). Here we evaluated effects of Peg and Plin on absolute platelet count by analyzing thrombocytopenia frequency (T).

Methods

We analyzed T Grade (Gr by CTCAE 4.03 criteria) in 4 treatment arms of BC patients receiving 4 cycles of TAC and Peg doses of either 0 mg (N = 15), 1.5 mg (N = 14), 3 mg (N = 21) or 6 mg (N = 16) in the phase (Ph) II Study BPI-2358-106 (NCT03294577). All pts in these 4 arms also received Plin 20 mg/m2. A 5th arm (N = 22) with SA Peg 6mg (without Plin) was also evaluated for T in study 106.

Results

Increasing Peg doses caused a statistically significant dose-dependent increase in T (Table below). T frequency with SA Plin was generally low (Table below) and not different from reported T frequency with TAC use (Any Gr T = 39% and Gr3/4 T = 2%; Taxotere Product Label). With SA Peg 6 mg (arm 5), Gr 1 (46%), Gr 2 (5%) and Gr 3 (9%), T was not significantly (P = 0.2) different vs Plin+Peg 6mg. Gr 4 T was not observed.Table:

1813P

Thrombocytopenia Frequency
Plin+ Peg 0 mgPlin+ Peg 1.5 mgPlin+ Peg 3 mgPlin+ Peg 6 mgP-Value of Peg Dose effect on T
T Any Grade26.7%35.7%52.4%93.8%P < 0.0001
T Grade 120%35.7%28.6%56.3%P = 0.03
T Grade 26.68%0%23.8%18.8%P = 0.056
T Grade 30%0%0%18.8%P < 0.01

Conclusions

Plin 20mg/m2 did not induce T. Peg caused a statistically and clinically significant dose-dependent increase in T. A ph III confirmatory trial is underway.

Clinical trial identification

BPI-2358-106.

Editorial acknowledgement

Legal entity responsible for the study

BeyondSpring Pharmaceuticals, Inc.

Funding

BeyondSpring Pharmaceuticals, Inc.

Disclosure

D.W. Blayney: Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: BeyondSpring Pharmaceuticals, Inc. I. Bondarenko: Honoraria (self): BeyondSpring Pharmaceuticals, Inc. Y. Shi: Honoraria (self), Advisory / Consultancy: BeyondSpring Pharmaceuticals, Inc. S. Ogenstad: Advisory / Consultancy, Travel / Accommodation / Expenses: BeyondSpring Pharmaceuticals, Inc. L. Du: Leadership role, Travel / Accommodation / Expenses, Full / Part-time employment, Officer / Board of Directors: Wanchun Bulin Pharmaceuticals, Inc; Shareholder / Stockholder / Stock options: BeyondSpring, Inc. L. Huang: Leadership role, Travel / Accommodation / Expenses, Full / Part-time employment, Officer / Board of Directors: BeyondSpring Pharmaceuticals, Inc; Shareholder / Stockholder / Stock options: BeyondSpring, Inc. R. Mohanlal: Leadership role, Travel / Accommodation / Expenses, Full / Part-time employment, Officer / Board of Directors: BeyondSpring Pharmaceuticals, Inc; Shareholder / Stockholder / Stock options: BeyondSpring, Inc.

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