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BeyondSpring’s Plinabulin Demonstrates Superior Quality of Life Over Pegfilgrastim in a Head-to-Head Comparison Trial for the Prevention of Neutropenia
In the Phase 2 portion of the Phase 2/3 study, a multicenter, randomized double-blind trial, all patients received docetaxel 75 mg/m2 on Day 1. Patients were randomly assigned one of three Plinabulin doses (5 mg/m2 [n=14], 10 mg/m2 [n=13] or 20 mg/m2 [n=14]) given by IV infusion 30 minutes after chemotherapy over four cycles, or the standard dose (6 mg) of Pegfilgrastim (Neulasta®) on Day 2. QoL was assessed with the validated health-related questionnaires before dose on Day 1 of each of the four cycles, prior to the study and at the end of treatment.
Plinabulin, in contrast to Pegfilgrastim and other G-CSFs, does not produce bone pain, which remains an unaddressed patient complaint with the use of Pegfilgrastim monotherapy.
“We measured patient reported outcomes (PRO) in our study, as PRO are increasingly recognized as important and valid by patients, regulatory agencies and payers. While this analysis is exploratory, these preliminary results are statistically and clinically significant and indicate improvements with Plinabulin in the QoL for patients being treated with docetaxel for advanced non-small cell lung cancer in addition to protecting against CIN,” said Dr.
“PRO are equally as important as validated clinical outcomes, and with Plinabulin we have created a treatment option that is effective for CIN prevention and improves the QoL for very sick patients,” added Dr.
About Chemotherapy-Induced Neutropenia (CIN)
As many as 90 percent of patients who receive high-risk chemotherapy and G-CSF monotherapy may still experience grade 3 or 4 neutropenia [Lee et al., Annals of Surgical treatment and research 94(5): 223-228 (2018)]. Patients with grade 4 (severe) neutropenia have an abnormally low concentration of neutrophils, making these patients more susceptible to bacterial / fungal infections and sepsis, which can require hospitalization and be fatal. Grade 4 CIN can have an adverse effect on chemotherapy administration and is usually considered a significant predictor of low relative dose intensity (RDI), dose delays and dose reductions [Lalami Y, Critical Reviews in Oncology / Hematology, 120: 163 – 179 (2017)]. Even a 15 percent chemotherapy dose reduction can reduce long-term survival by as much as 50 percent [Bonadonna, Med Oncol 29:1495–1501 (2012)].
Additionally, as many as 70 percent of patients using G-CSF monotherapy experience bone pain [Moore et al., Annals of Pharmacotherapy 51(9): 797-803 (2017)]. Twenty-five percent of patients also report that the pain is severe. The National Comprehensive Cancer Network (NCCN) guidelines require that patients with grade 3 or 4 neutropenia decrease chemotherapy dose intensity, delay chemotherapy cycle timing or discontinue chemotherapy, each of which can have a negative effect on the long-term outcomes of cancer care [Lalami et al., Critical Reviews in Oncology / Hematology 120: 163-179 (2017)].
Cautionary Note Regarding Forward-Looking Statements
Source: BeyondSpring, Inc.