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BeyondSpring’s Rationale for the Plinabulin-Neulasta Combination for Neutropenia Prevention Accepted as Abstracts at 2019 ASCO Annual Meeting
BeyondSpring’s first abstract (No. e12030), “Comparison of 6mg Pegfilgrastim, Plinabulin and the Combination for CIN Prevention: Rationale for the Combination,” evaluates whether combining Plinabulin with Neulasta, would protect patients against CIN throughout the entire chemotherapy cycle. The two agents have different mechanisms of action, with Plinabulin predominantly protective in the first week of the cycle, and Neulasta predominantly protective in the second week of the cycle. Protection was measured by evaluating the absolute neutrophil count (ANC). The data shows that Plinabulin, when added to the standard dose of Neulasta, offered CIN protection throughout the entire cycle, something that could not be achieved by each of these agents alone. The addition of Plinabulin to Neulasta, almost completely eliminated the Neulasta-induced bone pain, reducing its incidence of at least 1 day of bone-pain from 95 percent (with the standard dose of Neulasta) to 6 percent (with the Plinabulin-Neulasta combination) (p < 0.0001).
BeyondSpring’s second abstract (No. e12017), “Plinabulin Combined with Half Dose (3mg) Pegfilgrastim, Compared with Full Dose (6mg) Pegfilgrastim Alone for CIN: Neutrophil, Bone Pain and Immunosuppressive Effects,” compared patients who received a combination of Plinabulin with a half dose of Neulasta to patients who received a full dose of Neulasta alone to test the effects on CIN, bone pain and the immune-suppressive profile. The data highlights that a half dose of Neulasta, combined with Plinabulin, is equally effective against CIN as a full dose of Neulasta alone (demonstrating a strong neutropenia benefit). In addition, the combination therapy offered significantly lower levels of bone pain for patients, as well, along with a favorable immune profile compared to Neulasta alone.
“These results suggest that combining Plinabulin with Neulasta, the existing standard of care for CIN, makes the treatment better and more effective for patients,” said Dr.
“The combination of Plinabulin and Neulasta or G-CSF has the opportunity to improve care for patients, providers and payers,” added Dr.
The ASCO Annual Meeting 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.