BeyondSpring’s Plinabulin Holds its Own in Quality of Life Study
In the mid-stage BPI-2358-105 study, plinabulin and Neulasta were provided to patients with advanced non-small cell lung cancer. Patients were provided with one of three dose levels of plinabulin 30 minutes after chemotherapy, or the standard dose of Neulasta on day two following chemotherapy. The study revealed that the 20 mg dose of plinabulin demonstrated a significant improvement in quality of life over four treatment cycles. There were significant improvements in pain levels, fatigue and insomnia, BeyondSpring said in its announcement. Quality of life (QoL) was assessed with the validated health-related questionnaires before dose on the first day of each of the four cycles, prior to the study and at the end of treatment.
In previous clinical trials, BeyondSpring found that a dose of plinabulin at 20mg/ m2 of a 40mg fixed-dose has equal protection against severe chemotherapy-induced neutropenia (CIN) in comparison to Neulasta.
Plinabulin, in contrast to Neulasta and other G-CSFs, does not produce bone pain, which remains an unaddressed patient complaint with the use of pegfilgrastim monotherapy, the company said in its announcement. Up to 70% of patients using G-CSF monotherapy experience bone pain. Of those, 25% of patients classified the pain as severe. Bone pain is one of the reasons that patients may refuse treatment. Lan Huang, chief executive officer of BeyondSpring, told BioSpace earlier this year that multiple studies have shown plinabulin can reduce bone pain. She said patients have described the bone pain as intense and a feeling as if the bones are going to explode.
Douglas Blayney, the principal investigator for BeyondSpring’s chemotherapy-induced neutropenia (CIN) study, said the study focused on patient-reported outcomes (PRO), which have become increasingly recognized as important and valid by regulatory agencies and payers.
“While this analysis is exploratory, these preliminary results are statistically and clinically significant and indicate improvements with Plinabulin in the QoL for patients being treated with docetaxel for advanced non-small cell lung cancer in addition to protecting against CIN,” Blayney said in a statement.
Neutrophils are a type of white blood cell that fights infections in the body. CIN occurs when neutrophils are not being produced due to the effects of chemotherapy. CIN increases a patient's risk of infection and disrupts their cancer treatment.
Full data from the study will be presented during the IASLC World Conference on Lung Cancer in Barcelona, Spain on Sept. 8. Blayney, also a professor of medicine at Stanford University, will make the presentation.
Ramon Mohanlal, BeyondSpring’s chief medical officer and head of research and development, pointed to the increasing validity of PRO in clinical trials. With plinabulin, Mohanlal said BeyondSpring has created a treatment option that is effective for CIN prevention and also improves the quality of life for very sick patients. With this data in hand, as well as data from previous late-stage trials, Mohanlal said BeyondSpring is preparing for the submission of New Drug Applications in the United States, as well as China for plinabulin.