BeyondSpring (BYSI) to Present Three Abstracts from PROTECTIVE-2 Phase 3 Trials of Plinabulin at ASCO

June 7, 2021 7:05 AM EDT

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BeyondSpring Inc. (NASDAQ: BYSI) announced the presentation of three abstracts reporting on data from the PROTECTIVE-2 Phase 3 clinical program of plinabulin in combination with pegfilgrastim for prevention of Chemotherapy-induced neutropenia (CIN) at the American Society of Clinical Oncology (ASCO) Annual Meeting being held on June 4 - 8, 2021.

“Chemotherapy-induced neutropenia continues to represent an unmet medical need despite the use of G-CSF, thus novel approaches are needed. Chemotherapy will continue to be used either alone or in combination with immunotherapy. The addition of plinabulin to G-CSF, including pegfilgrastim, recently received the Breakthrough Designation and NDA Priority Review from both the U.S. FDA and China NMPA, solidifying the validity of the concept combining two complementary CIN agents. The combination achieved superior results over standard on care pegfilgrastim (G-CSF) alone, especially when considering important measures of clinical benefit such as febrile neutropenia rates and hospitalization in addition to patient quality of life," said Dr. Douglas Blayney, Professor of Medicine at Stanford University Medical School and global PI for CIN studies.

The poster, titled “Clinical Trial Testing Superiority of Combination Plinabulin (Plin) and Pegfilgrastim (Peg) vs Peg Alone in Patients (pts) with Breast Cancer treated with High Febrile Neutropenia Risk chemotherapy (chemo): Final results of the Phase 3 Chemo-Induced Neutropenia (CIN) Prevention Trial (PROTECTIVE-2)” was presented at 9:00 a.m. ET on June 4, 2021, at Lung Cancer Poster Session (Abstract #533). The superiority in ANC (absolute neutrophil number) based endpoints are correlated with improved clinically meaningful outcome measures of CIN, including FN and hospitalization, in ITT population.

  • Reduction in incidence and severity of FN: The FN incidence (3.6%) in the combination arm is approximately 50% of that of the pegfilgrastim arm (6.3%), and has 50% shorter duration of FN (1.25 day vs. 2.28 day);
  • Reduction in duration of hospitalization: Duration of hospitalization is approximately 50% less in the combination arm (3.75 day) compared to that in pegfilgrastim arm (7.14 day);
  • Reduction in change in chemo dose and/or regimen in later cycles: The clinical consequence of changing chemo dose and/or chemo regimen in later cycles is approximately 50% lower in the combination vs. pegfilgrastim alone (2.7% vs. 6.3%).

The poster, titled “Chemotherapy Induced Profound Neutropenia (PN) in Patients (pt) with Breast Cancer (BC) after chemotherapy and Plinabulin (Plin) plus Pegfilgrastim (Peg) Combination versus (vs) Peg Alone. Final Phase 3 Results from PROTECTIVE-2 (BPI-2358-106),” was presented at 9:00 a.m. ET on June 4, 2021, at Lung Cancer Poster Session (Abstract #546) additionally highlights the superiority of the plinabulin combination, in reducing the incidence of the most severe form of neutropenia, profound neutropenia (ANC < 0.1 x 109 cells/L), by more than 50% in incidence (21.6% vs. 46.4%, p=0.001) as well as the duration of profound neutropenia (0.34 days vs 0.63 days, p=0.0004), which is correlated with reduction of clinical consequences of FN and hospitalization in these profound neutropenia patients.

  • Reduction of incidence of FN from 13.7% in pegfilgrastim arm to 4.2% in the combination arm for patients with profound neutropenia;
  • Reduction of hospitalization rate from 11.8% in pegfilgrastim arm to 8.3% in the combination arm for patients with profound neutropenia.

The third poster, titled “Impact of Adding Plinabulin to Pegfilgrastim for the Prevention of TAC Chemotherapy (Chemo) Induced Neutropenia (CIN), on Patient Quality of Life (QoL),” was presented on June 4, 2021, at Lung Cancer Poster Session (Abstract #e24031). This is the first study to quantify physical wellbeing (pain and energy levels) of patients receiving plinabulin in combination with pegfilgrastim compared to pegfilgrastim alone.

  • Better QoL with faster recovery from chemotherapy treatment: The combination performed significantly better on Days 8 and 15 of Cycle 2 of chemotherapy (p<0.0589 and p<0.0039 respectively) as well as Days 8 and 15 in Cycle 3 (p<0.0360 and p<0.0343 respectively), suggesting these patients recovered their pre-chemo wellbeing more rapidly than those treated with pegfilgrastim alone.

“We are very pleased to announce new positive clinical outcome data from the PROTECTIVE-2 Phase 3 program. The three ASCO abstracts provide collective evidence of plinabulin and pegfilgrastim combination’s superior effectiveness for the prevention of CIN compared to pegfilgrastim alone, not only in ANC based endpoints, but also in clinical outcome, including FN, hospitalization, and QoL. These benefits contribute to favorable benefit and risk ratio of this regimen, which address the current unmet medical needs in CIN.” Said Ramon Mohanlal M.D., Ph.D., Chief Medical Officer and Executive Vice President of Research and Development at BeyondSpring.

The Company has submitted New Drug Applications (NDA) for plinabulin in combination with pegfilgrastim as a treatment for the prevention of CIN for review in both the U.S. and China. The U.S. FDA accepted the NDA with Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) action date of November 30, 2021.

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