Douglas W. Blayney, MD, is a professor of medicine (oncology) at Stanford University and the former Medical Director of Stanford Cancer Center. He specializes in breast cancer treatment. He is particularly concerned about the quality and value of cancer care. In this video Dr. Blayney discusses the Phase 3 PROTECTIVE-2 TRIAL.
Plunabulin significantly reduces bone pain in breast cancer patients (pts) treated with TAC (docetaxel, doxorubicin, cyclophosphamide) and pegfilgrastim, according to mechanistic evidence (Peg)
Publication Number: P5-18-01
Patients who received both pegfilgrastim and plinabulin experienced less bone discomfort than those who received only pegfilgrastim (p=0.03).
Planabulin treatment may reduce the requirement for compensatory hematopoiesis and intracavitary pressure build-up, which can cause bone pain.
At the nadir, patients who received pegfilgrastim and plinabulin had a higher absolute neutrophil count (ANC) (the point of their lowest ANC).
TAC+Peg (30%) vs TAC+Peg+Plin (18%), p=0.03. Treatment-emergent adverse events of bone pain, cycles 1 to 4 (percentage of patients): TAC+Peg (30%) vs TAC+Peg+Plin (18%), p=0.03.
TAC+Peg (0.32) vs TAC+Peg+Plin (0.54), p=0.0002. ANC nadir during cycle 1 (mean ANC nadir (109 cells/L)): TAC+Peg (0.32) vs TAC+Peg+Plin (0.54), p=0.0002.
TAC+Peg vs TAC+Peg+Plin, p=0.019, the depth of ANC nadir was statistically substantially connected with bone pain levels.
In early-stage breast cancer (BC) patients (pts) treated with taxotere, doxorubicin, and cyclophosphamide, the combination plinabulin+pegfilgrastim (Plin+Peg) showed better toxicity management and health-related quality-of-life (HrQoL) than Peg alone (TAC)
Publication Number: P5-18-04
The addition of plinabulin to pegfilgrastim reduces toxicity and improves HrQoL in breast cancer patients taking TAC. In view of the improved outcomes found with the inclusion of plinabulin and pegfilgrastim, TAC should be reevaluated for patients with early-stage breast cancer.
The profile of adverse events (AEs) among individuals receiving plinabulin and pegfilgrastim was altered toward lower-grade AEs.
Significant change in EQ-5D-5L utility values, Cycles 1 to 4 for TAC+Peg vs TAC+Peg+Plin, p=0.024; significant change in EQ-5D-5L utility values, Cycles 1 to 4 for TAC+Peg vs TAC+Peg+Plin, p=0.024; significant change in EQ-5D-5L utility values, Cycles 1 to 4 for TAC+Peg
Plinabulin’s Background
Plinabulin, BeyondSpring’s primary asset, is a strong antigen presenting cell (APC) inducer and a selective immunomodulating microtubule-binding agent (SIMBA). It’s a patent-protected, intravenous injected CIN prevention asset as well as a Phase 3 anti-cancer candidate for non-small cell lung cancer (NSCLC) with recently revealed good topline data. Plinabulin causes the immune defense protein GEF-H1 to be released, which has two effects: the first is a long-lasting anticancer benefit from dendritic cell maturation, which results in the activation of tumor antigen-specific T-cells to target cancer cells, and the second is an early onset of action in CIN prevention after chemotherapy by increasing the number of hematopoietic stem/progenitor cells (HSPCs). Plinabulin has been designated as a Breakthrough Therapy by the US and Chinese Food and Drug Administrations for the prevention of CIN. Plunabulin is being explored in combination with several immuno-oncology medicines as a “pipeline in a medication” that could enhance the effects of PD-1/PD-L1 antibodies and re-sensitize PD-1/PD-L1 antibody-resistant patients.