BeyondSpring (NASDAQ: BYSI) announced new clinical results from its Study 106 program for lead asset Plinabulin, which demonstrates that combining Plinabulin with Neulasta not only improves overall efficacy for chemotherapy-induced neutropenia (CIN) treatment but also reverses Neulasta’s potential immune-suppressive phenotype.
Dr. Douglas Blayney, global Principal Investigator for BeyondSpring’s CIN development program and Professor of Medicine at Stanford University Medical Center, will present the data in a poster presentation at the 2019 ASCO-SITC Clinical Immuno-Oncology Symposium on March 1.
In its Study 106 (using TAC, or taxotere, doxorubicin and cyclophosphamide, as an example of high-risk chemotherapy), BeyondSpring evaluated whether combining Plinabulin with Neulasta would reverse the immune-suppressive neutrophil profile induced by Neulasta. Breast cancer patients received TAC chemotherapy, followed by Neulasta monotherapy, Plinabulin monotherapy or Plinabulin combined with Neulasta and analyzed neutrophil-to lymphocyte ratio (NLR) levels.
The Plinabulin and Neulasta combination data shows better efficacy for the treatment of CIN, versus Neulasta alone, while preventing neutrophil overproduction.
The percentage of patients with grade 4 neutropenia was lowered from 59% with Neulasta alone to 38% with the combination, and the percentage of patients with an absolute neutrophil count exceeding the upper limit of what is considered normal was lowered from 50% with Neulasta alone to 31% with Neulasta and Plinabulin.
In addition, immune-suppressive NLR levels were lower in the Plinabulin/Neulasta combination, compared with Neulasta alone.
“These new results from our poster presentation at this year’s ASCO-SITC Symposium, which marks BeyondSpring’s first abstract for Phase 2 of Study 106, provide additional rationale for developing Plinabulin in combination with Neulasta,” Dr. Blayney said in a statement. “This combination provides immense clinical benefit and reinforces earlier data from our studies with Plinabulin.”
Dr. Ramon Mohanlal, EVP of R&D and CMO of BeyondSpring, said the cancer treatment landscape is increasingly moving toward immunotherapy/chemotherapy combinations that also cause CIN.
“With high-risk febrile neutropenia, and with immunotherapy/chemotherapy combinations, the Plinabulin and Neulasta combination is expected to provide superior protection against CIN while avoiding a predominant immune-suppressive tumor microenvironment,” he added.
