BeyondSpring Presents Positive Data with Plinabulin for the Prevention of Docetaxel-Induced Neutropenia in Patients with Non-Small Cell Lung Cancer and Breast Cancer at Three Medical Conferences
13 Dezembro 2022 - 10:00AM
BeyondSpring Inc. (the “Company” or “BeyondSpring”) (Nasdaq: BYSI),
a clinical stage global biopharmaceutical company focused on
developing innovative cancer therapies, today announced data from
the ESMO Asia Congress 2022 and the American Society of Hematology
(ASH) Annual Meeting about the use of lead asset, plinabulin, for
the prevention of docetaxel-induced neutropenia (DIN) in non-small
cell lung cancer (NSCLC) patients. In addition, data was presented
on plinabulin for the prevention of docetaxel-induced neutropenia
in breast cancer (BC in the 105 study) at the 2022 San Antonio
Breast Cancer Symposium (SABCS). The analyses in the NSCLC studies
support the efficacy of plinabulin as a monotherapy in reducing the
mean duration of severe neutropenia (DSN) with a >1 day benefit
for patients receiving docetaxel and plinabulin (compared to
patients not receiving plinabulin) in two independent randomized
trials (study 101 and 103).
“Docetaxel-induced neutropenia can cause life-threatening
infections in cancer patients, and the current standard of care,
prophylactic treatment with a G-CSF in high-risk patients, has
limitations. It has to be administered 24 hours following
chemotherapy, and patients can experience post-treatment bone pain,
a mild reduction in platelet count and a decline in quality of
life,” said Dr. Douglas Blayney, professor of medicine (oncology)
emeritus at Stanford University Medical School and global principal
investigator for the plinabulin neutropenia prevention studies.
“The data that we presented at these three conferences demonstrate
that plinabulin can provide solutions for some of the challenges
seen with G-CSF. Plinabulin is given on the same day as
chemotherapy as a short infusion, has minimal associated bone pain,
no reduction in platelet count and quality of life is maintained
throughout the course of therapy. Importantly, the analyses showed
a reduction in mean DSN of one day or more in NSCLC patients
receiving plinabulin vs placebo (no G-CSF), which is the gold
standard for regulatory review.”
Trials Mentioned in the Abstracts
- study 101: Phase 2 study of plinabulin and docetaxel (75 mg/m2)
vs. docetaxel alone (75 mg/m2) in 2nd/3rd line NSCLC
(NCT00630110)
- study 103: Phase 3 study of plinabulin and docetaxel (75 mg/m2)
vs. docetaxel alone (75 mg/m2) in 2nd/3rd line NSCLC
(NCT02504489)
- study 105: Phase 2/3 study of plinabulin vs. pegfilgrastim with
docetaxel (75 mg/m2) treatment in NSCLC, breast cancer and prostate
cancer (NCT03102606)
Poster Presentation at the ASH Annual
Meeting
Title: Prevention of Docetaxel (Doc)-Induced
Neutropenia (DIN) with Single Agent Plinabulin (Plin) Versus (vs)
Control (No-Treatment or Placebo) in Non-Small Cell Lung Cancer
(NSCLC) in Two Randomized TrialsPresentation
Number: 1094 Presenter: Dr. Douglas
Blayney, professor of medicine (oncology) emeritus at Stanford
University Medical School and global principal investigator for the
plinabulin neutropenia prevention studies
The presentation summarized data from two randomized NSCLC
studies (study 101 and 103), and DIN results were compared between
the plinabulin arm and the control arm (placebo or no treatment).
The DSN was calculated based on Day 8 absolute neutrophil count
(ANC) values in the plinabulin and control arms.
- In NSCLC patients, docetaxel 75 mg/m2 is typically used without
G-CSF prophylaxis (“no treatment”). This analysis focuses on the
effectiveness of plinabulin (20 mg/m2 or its pharmacokinetic
equivalent exposure) vs. control for the prevention of DIN in the
101 and 103 studies.
- In summary, in these two independent randomized studies,
plinabulin demonstrated a superior benefit for Gr4N, Gr3/4N, all
GrN and DSN compared to the control. Importantly, in both these
randomized studies, there was a reduction in mean DSN of >1 day
for plinabulin vs. control.
Oral Presentation at ESMO Asia Congress
2022
Title: 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)Presentation Number:
276MO Presenter: Dr. Douglas Blayney, professor of
medicine (oncology) emeritus at Stanford University Medical School
and global principal investigator for the plinabulin neutropenia
prevention studies
The presentation summarized DIN data from a non-randomized
comparison derived from two different studies: plinabulin data from
study 105 and the control (placebo or no treatment) data from study
103.
- In the 105 study, NSCLC pts with at least one febrile
neutropenia (FN) risk factor received docetaxel 75 mg/m2 with
plinabulin (20 mg/m2 or its equivalent of 40 mg fixed dose,
n=30).
- In the 103 study, patients received docetaxel 75 mg/m2 without
plinabulin (placebo; n=224).
- In summary, plinabulin was superior for the prevention of DIN
and hematologic complications vs control: Grade 4 Neutropenia: 17%
with plinabulin vs 40% with placebo (p-value=0.02). In addition,
the mean DSN was 0.43 days for plinabulin vs. 1.32 days for placebo
(p-value=0.002). There was also a favorable quality of life and
safety profile with plinabulin.
Poster Presentation at SABCS
Title: Superior effectiveness of Plinabulin
(Plin) versus no-treatment for Docetaxel (Doc)-induced neutropenia
(N) and other hematologic complication in breast cancer (BC)
patientsPresentation Number: P1-12-10
Presenter: Dr. Douglas Blayney, professor of
medicine (oncology) emeritus at Stanford University Medical School
and global principal investigator for the plinabulin neutropenia
prevention studies
The presentation summarized DIN data for plinabulin from study
105 and the control data (placebo or no treatment) was taken from
the literature.
- The hematologic complications
endpoints from the 27 early breast cancer patients with at least
one NCCN high FN risk factor (N=27) from the Phase 3 portion of 105
study were compared with the no-treatment studies from literature
where patients were given 75 mg/m2 docetaxel without G-CSF (Harvey
et al., JCO, 2006 and Dieras et al., Br J Ca, 1996). Blood sampling
in the no-treatment studies (Harvey and Dieras) were infrequent and
likely underestimated the true grade 4 neutropenia frequency.
- In summary, despite a higher
frequency of ANC sampling in cycle 1, plinabulin was superior vs
no-treatment for DIN and hematologic complications. Quality of life
was maintained, and there were minimal adverse effects including
minimal bone pain burden in the plinabulin arm vs.
no-treatment.
About Plinabulin Plinabulin,
BeyondSpring’s lead asset, is a selective immunomodulating
microtubule-binding agent, which is a potent antigen presenting
cell (APC) inducer that is being developed as an anticancer agent.
Plinabulin triggers the release of the immune defense protein,
GEF-H1, which leads to two distinct effects: first is a durable
anti-cancer benefit due to the maturation of dendritic cells
resulting in the activation of tumor antigen-specific T-cells to
target cancer cells and the second is a CIN prevention benefit.
Plinabulin has single agent anti-cancer activity in a number of
cancers including small cell lung cancer (SCLC) and multiple
myeloma (MM). Plinabulin also exerts early-onset of action in the
prevention of chemotherapy-induced neutropenia (CIN) by boosting
the number of hematopoietic stem/progenitor cells (HSPCs).
About BeyondSpringHeadquartered in New York
City, BeyondSpring is a clinical stage global biopharmaceutical
company focused on developing innovative cancer therapies to
improve clinical outcomes for patients who have high unmet medical
needs. BeyondSpring’s first-in-class lead asset, plinabulin, is
being developed as a potential “pipeline in a drug” in various
cancer indications as a direct anti-cancer agent and to prevent
chemotherapy-induced neutropenia (CIN). The plinabulin and G-CSF
combination for the prevention of CIN has demonstrated positive
Phase 3 data in the PROTECTIVE-2 study. In the DUBLIN-3 study, a
global, randomized, active controlled Phase 3 study, the plinabulin
and docetaxel combination met the primary endpoint of extending
overall survival compared to docetaxel alone in 2nd/3rd line
non-small cell lung cancer (NSCLC) (EGFR wild type). Additionally,
plinabulin is being broadly studied in combination with various
immuno-oncology regimens that could boost the efficacy of
PD-1/PD-L1 antibodies in seven different cancers. Lastly,
BeyondSpring’s pipeline includes three preclinical immuno-oncology
assets and a subsidiary, SEED Therapeutics, which is leveraging a
proprietary targeted protein degradation drug discovery platform
with initial R&D collaboration with Eli Lilly.
Investor
Contact:IR@beyondspringpharma.comMedia
Contact:PR@beyondspringpharma.com
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