BeyondSpring (NASDAQ:BYSI) presented new clinical results from its Study 106 program in the prevention of chemotherapy-induced neutropenia (CIN) for its lead asset Plinabulin at the 2019 ASCO-SITC clinical immuno-oncology symposium.
By combining Plinabulin with Neulasta, the data showed that patients not only experienced better outcomes for CIN treatment, but Neulasta’s potential immune-suppressive phenotype was also reduced.
Neulasta, a long-acting granulocyte-colony stimulating factor and the current standard-of-care for CIN, activates the bone marrow, resulting in a temporary overproduction of neutrophils, many of which are immature. Immature neutrophils can travel to the tumor tissue and cause the microenvironment to be immune-suppressive.
BeyondSpring evaluated whether combining Plinabulin with Neulasta would reverse the immune-suppressive neutrophil profile induced by Neulasta.
BeyondSpring’s Study 106 used taxotere, doxorubicin and cyclophosphamide as an example of high febrile neutropenia risk chemotherapy. Patients were randomly assigned to treatment arms with Neulasta alone, Neulasta combined with Plinabulin or Plinabulin alone.
The combination of Plinabulin with Neulasta resulted in better protection against CIN. The data also demonstrated that adding Plinabulin to Neulasta reversed the immune-suppressive profile of Neulasta by lowering the percentage of patients with a neutrophil-to-lymphocyte ratio of less than five or with a lymphocyte-to-monocyte ratio of greater than 3.2, compared with Neulasta alone.
“The Plinabulin and full Neulasta combination not only is more effective than either alone, but also significantly reduces bone pain and improves patients’ quality of life,” Dr. Douglas Blayney, global principal investigator for BeyondSpring’s CIN development program and Prof. of medicine at Stanford University Medical Center, said in a statement.
“This new data we presented at ASCO-SITC will benefit both patients and their physicians. We think our combination therapy is the future of cancer care,” he added.
Dr. Ramon Mohanlal, EVP of R&D and CMO of BeyondSpring, said the data would set the stage for BeyondSpring’s NDA filings in both the U.S. and China later in 2019.
