BeyondSpring Announces Final Positive Data from the PROTECTIVE-1 Phase 3 CIN Program of Plinabulin as a Single Agent Compared to Pegfilgrastim at the American Society of Clinical Oncology (AS
NEW YORK, June 10, 2021 (GLOBE NEWSWIRE) --?BeyondSpring Inc.?(the ?Company? or ?BeyondSpring?) (NASDAQ: BYSI), a global biopharmaceutical company focused on the development of innovative cancer therapies, today announced presentation of data from the PROTECTIVE-1 Phase 3 clinical study of plinabulin for prevention of chemotherapy-induced neutropenia (CIN) at the American Society of Clinical Oncology (ASCO) Annual Meeting being held on June 4 - 8, 2021.
The poster titled ?Head-to-Head Comparison of Single Agent (SA) Plinabulin (Plin) versus Pegfilgrastim (Peg) for the Prevention of Chemotherapy-Induced Neutropenia (CIN) in the Phase 3 Trial PROTECTIVE-1,? was presented at 9:00 a.m. ET on June 4, 2021, at Lung Cancer Poster Session (Abstract #547) is the PROTECTIVE-1 Phase 3 data comparing plinabulin versus pegfilgrastim. Data further supports plinabulin?s fast onset of action and CIN prevention benefit in week 1 following chemotherapy with results including clinically meaningful endpoints for reduction of febrile neutropenia (FN), hospitalization and bone pain.
- Primary endpoint of demonstrating non-inferiority of single agent plinabulin versus single agent pegfilgrastim was met:?DSN (days of severe neutropenia) cycle 1, non-inferiority margin of 0.65 day criterion between plinabulin and pegfilgrastim was met.
- Comparable or numerically better clinical sequelae of CIN for plinabulin vs. pegfilgrastim:
FN | Infection | Antibiotics Use | Hospitalization | Docetaxel Discontinue | Docetaxel Delay | |||||||
Plin (n=52) | 0% | 7.69% | 15.4% | 3.84% | 13.5% | 3.85% | ||||||
Peg (n=53) | 1.89% | 15.1% | 13.2% | 1.89% | 26.4% | 5.66% |
- Significant improvement in bone pain and platelet count:?Less bone pain (p=0.01) and less thrombocytopenia (p<0.0001 on D15) compared to pegfilgrastim.
- Same day convenience of use:?Plinabulin is infused on the same day (Day 1) as chemotherapy, 30 minutes after chemotherapy with 30 minutes of intravenous infusion, whereas pegfilgrastim on the next day (Day 2).
- PROTECTIVE-1 Phase 2?(4arm randomized study, NSCLC, docetaxel, n=55): Plinabulin single agent (5 mg/m2, 10 mg/m2, or 20 mg/m2, day 1 dose), pegfilgrastim (6 mg, day 2 dose).?Plinabulin 20 mg/m2 was selected as the Phase 3 dose.
- PROTECTIVE-1 Phase 3?(2 arm randomized, double-blind study, NSCLC, breast cancer, prostate cancer, docetaxel, n=105 patients): Plinabulin single agent (40 mg fixed dose ? equivalent to 20 mg/m2, day 1 dose) vs. pegfilgrastim (6 mg, day 2 dose). Primary endpoint DSN cycle is met with non-inferiority.?Plinabulin showed week 1 early onset of action and was effective in prevention of clinical outcomes, such as FN and hospitalization, and chemo dose reduction and delay.
- PROTECTIVE-2 Phase 2?(7 arm randomized study, breast cancer, TAC, n=115 patients): Plinabulin single agent (10 mg/m2, 20 mg/m2, or 30 mg/m2, day 1 dose) ? 20 mg/m2 selected; Plinabulin (20 mg/m2, day 1 dose) + pegfilgrastim (1.5 mg, 3 mg, or 6 mg, day 2 dose); pegfilgrastim (6 mg, dose 2 dose).?Plinabulin (20 mg/m2) and pegfilgrastim (6 mg) was selected to be Phase 3 dose.
- PROTECTIVE-2 Phase 3?(2 arm randomized, double-blind study, breast cancer, TAC, 221 patients ? Pivotal study): Plinabulin (40 mg fixed dose ? equivalent to 20 mg/m2, day 1 dose) + pegfilgratstim (6 mg, day 2 dose) vs. pegfilgrastim (6 mg, day 2 dose).?The combination is superior to pegfilgrastim alone, which met primary endpoint of prevention of grade 4 neutropenia and key secondary endpoints, with superior benefit in reducing the incidence and severity of febrile neutropenia (FN) and hospitalization, with better quality-of-life (QoL)