On December 13, 2022 BeyondSpring Inc. (the "Company" or "BeyondSpring") (Nasdaq: BYSI), a clinical stage global biopharmaceutical company focused on developing innovative cancer therapies, reported data from the ESMO (Free ESMO Whitepaper) Asia Congress 2022 and the American Society of Hematology (ASH) (Free ASH Whitepaper) 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).

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"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) docetaxel alone (75 mg/m2) in 2nd/3rd line NSCLC (NCT00630110)
study 103: Phase 3 study of plinabulin and docetaxel (75 mg/m2) 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 (Free ASH Whitepaper) 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 Trials

Presentation 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) 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 (Free ESMO Whitepaper) 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) patients

Presentation 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).