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BeyondSpring Abstract Demonstrating Bone Pain Benefit with Lead Asset, Plinabulin, versus Neulasta for Neutropenia Prevention Presented at ISPOR 2019
The data, derived from BeyondSpring’s Phase 2 Study 105, shows that Plinabulin at 20mg/m2 has a similar efficacy profile in reducing docetaxel-induced neutropenia as Neulasta 6mg (pegfilgrastim, the current standard of care), with the added safety benefit of avoiding the patient-reported bone pain that’s typically observed with Neulasta. BeyondSpring’s poster presentation will take place on
Bone pain is a known side effect of Neulasta, and is different and distinct from the pain produced by metastatic cancer. BeyondSpring’s abstract, titled “Reduction in Patient-Reported Bone Pain with Plinabulin vs. Pegfilgrastim in Non-Small Cell Lung Cancer Patients Treated for the Prevention of Docetaxel-Induced Neutropenia,” evaluates this quality of life and safety endpoint prospectively in a randomized, open-label study of Plinabulin, compared with Neulasta, for the prevention of docetaxel-induced neutropenia in patients with advanced or metastatic non-small cell lung cancer. Patients were randomized to receive four 21-day cycles of docetaxel (75mg/m2) with either Neulasta at 6mg or Plinabulin at 5mg/m2, 10mg/m2 or 20 mg/m2. Forty-one patients completed the study in total.
When measuring “pain at its worst in the last 24 hours,” in patients with no pain at baseline (cycle 1 day 1), those on the 20mg/m2 Plinabulin arm reported minimal to no change in bone pain vs baseline, versus patients in the 6mg Neulasta arm who reported changes in bone pain beginning on Day 3. The pain also peaked on Day 7 before declining. Additionally, when measuring “pain on average,” patients in the 20mg/m2 Plinabulin arm showed an 8.3 percent increase on Day 5, but patients in the 6mg Neulasta arm exhibited an increase in pain starting on Day 3 – two days sooner. Similar results were observed for patients who had pre-existing bone pain – presumably from metastatic cancer – prior to any study treatment.
“Bone pain is a significant quality of life issue for patients who are undergoing chemotherapy treatment, and it is no longer acceptable to consider this the status quo,” said Dr.
The ISPOR 2019 Conference will take place on
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.