- Data demonstrate that combination of plinabulin and pegfilgrastim offers superior benefit for reducing the incidence and severity of febrile neutropenia (FN) and hospitalization, with better quality-of-life (QoL), compared to pegfilgrastim alone
“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
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
- 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
- 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
- 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
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
About CIN
CIN remains a severely unmet medical need and is the primary cause for the 4D’s (Decrease, Delay, Discontinue dose and Downgrade regimen) that compromise carefully selected cancer treatment regimens. Treatment or prevention of CIN with G-CSF has been the standard of care since Neupogen® was approved in 1991. The main benefit of G-CSF treatment, however, is in Week 2 after chemotherapy. Week 1 after chemotherapy is considered the “neutropenia vulnerability gap” where over 75% of CIN-related clinical complications occur, including febrile neutropenia, infection, hospitalization and death. Plinabulin is the first drug seeking FDA approval that has the potential to fill this gap. Combining plinabulin and G-CSF may maximize the protection of patients for the full cycle of chemotherapy, as demonstrated in the PROTECTIVE-2 Phase 3 registration study.
Each year in the
About Plinabulin
Plinabulin, BeyondSpring’s lead asset, is a selective immunomodulating microtubule-binding agent (SIMBA). It is a novel, intravenous infused, patent-protected, NDA ready asset for CIN prevention indication and a Phase 3 anti-cancer candidate for non-small cell lung cancer (NSCLC). Plinabulin triggers the release of the immune defense protein, GEF-H1, which leads to two distinct effects: first is a durable anticancer 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 early-onset action in CIN prevention after chemotherapy by boosting the number of hematopoietic stem/progenitor cells (HSPCs). Plinabulin received breakthrough designation from both US and China FDA for CIN prevention indication. As a “pipeline in a drug,” plinabulin is being broadly studied in combination with various immuno-oncology agents that could boost the effects of the PD-1/PD-L1 antibodies and re-sensitize PD-1/PD-L1 antibody resistant patients.
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This press release includes forward-looking statements that are not historical facts. Words such as “will,” “expect,” “anticipate,” “plan,” “believe,” “design,” “may,” “future,” “estimate,” “predict,” “objective,” “goal,” or variations thereof and variations of such words and similar expressions are intended to identify such forward-looking statements. Forward-looking statements are based on BeyondSpring’s current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of several factors including, but not limited to, difficulties raising the anticipated amount needed to finance the Company’s future operations on terms acceptable to the Company if at all, unexpected results of clinical trials, delays or denial in the regulatory approval process, results that do not meet our expectations regarding the potential safety, the ultimate efficacy or clinical utility of our product candidates, increased competition in the market, and other risks described in BeyondSpring’s most recent Form 20-F on file with the
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