BeyondSpring (NASDAQ:BYSI) reported new data from its lead asset, Plinabulin, for the prevention of chemotherapy-induced neutropenia (CIN) at the American Society of Hematology (ASH) annual meeting.
Plinabulin is currently in late-stage clinical development for the prevention of CIN and as an anticancer therapy in non-small cell lung cancer.
CIN is a side effect of chemotherapy, and despite the broad use of G-CSFs for more than 25 years, febrile neutropenia and resultant hospitalization remain an unresolved clinical problem. In addition, bone pain is a common side effect of G-CSF, which limits patient compliance and results in suboptimum chemotherapy dosing.
The data continue to add evidence that Plinabulin has a unique mechanism of action, compared with G-CSF (granulocyte-colony stimulating factor) – the current standard of care in CIN prevention – and is a potential new option for CIN in intermediate-risk chemotherapy patients as a single agent.
Among the company’s findings is that Plinabulin monotherapy is an equally effective single-dose-per cycle agent in intermediate neutropenic risk CIN, but with minimal bone pain, when compared with pegfilgrastim.
In addition, combining Plinabulin and pegfilgrastim demonstrates superior CIN efficacy in high risk for CIN and febrile neutropenia, compared to G-CSF alone, and almost eradicates pegfilgrastim-induced bone pain.
The company also reported that Plinabulin mobilizes CD34+ progenitor cells into the peripheral blood through a mechanism of action different than G-CSF or the G-CSF alternative Plerixafor, potentially presenting a new option for hematopoietic cell transplantation.
“The CD34+ finding with Plinabulin has potentially not only medical, but also commercial significance as it adds an additional indication to the Plinabulin product label, which pegfilgrastim and its biosimilars do not have,” Dr. Lan Huang, co-founder and CEO, said in a statement.
“This further adds to Plinabulin’s holistic product profile, as an anticancer agent that can prevent severe CIN, without causing overt bone pain, and with protection against chemotherapy-induced thrombocytopenia,” Dr. Huang added.
