Plinabulin is being evaluated for the prevention of chemo-induced neutropenia (CIN) and is currently in two global multi-center clinical trials aiming for a broad indication of prevention of all chemo-induced neutropenia in all cancer type.
Study 106 is a Phase 2/3 trial of Plinabulin in combination with Neulasta, a long lasting G-CSF, (Plinabulin / Neulasta Combo) versus Plinabulin monotherapy versus Neulasta monotherapy after a high risk myelosuppressive chemotherapeutic regimen composed of three agents, Taxotere (docetaxel), Adriamycin (doxorubicin) and Cytoxan (cyclophosphamide), or TAC, for advanced breast cancer patients. The top line of Phase 2 portion of this study was read out in October 2018.
Study 105 is a Phase 2/3 trial of Plinabulin versus Neulasta after a standard regimen of docetaxel, an intermediate risk chemotherapy, for advanced breast cancer, hormone refractory prostate cancer and advanced NSCLC patients. The Phase 3 portion of this study has met its primary endpoint of non-inferiority for the duration of severe neutropenia (DSN) in the first cycle in a pre-specified interim analysis.
We believe that the clinical profile of Plinabulin in combination of a G-CSF (Plinabulin / G-CSF Combo) such as its potential for improved clinical outcome in neutropenia, lower bone pain, prevention of immune suppression, and its anti-cancer effects, has the potential to set a new standard in the prevention of CIN in patients treated by high risk chemotherapy. By improving clinical outcomes in neutropenia and reducing bone pain, the Plinabulin / G-CSF Combo has the potential to enable patients to maintain chemotherapy target dose, keep to their chemotherapy cycle times and complete the full course of chemotherapy. When this occurs patients have significantly better long-term outcomes.
Plinabulin also has a superior clinical profile against a G-CSF such as lower bone pain, prevention of immune suppression and no thrombocytopenia in the prevention of CIN in patients treated by intermediate risk chemotherapy where G-CSF is cautioned against.
For details of these two trials, please visit the below websites.