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Clinical Results for BeyondSpring’s Lead Asset, Plinabulin for the Prevention of Chemotherapy-Induced Neutropenia, Demonstrated Superior Immune Profile Compared to Neulasta®
Company to Present Latest Findings at 2018
The data showed that, Neulasta induced a peripheral blood immune profile that is known to potentially increase immune suppression. In contrast, Plinabulin did not generate this predominant immunosuppressive phenotype. Neulasta, a long-acting G-CSF and the current standard of care for chemotherapy-induced neutropenia (CIN), is believed to activate the bone marrow, resulting in an overproduction of neutrophils. Clinical data suggest that a large proportion of these neutrophils appear to represent immature neutrophils, which typically make their way to the tumor tissue, and tip the immune balance in the tumor into an immune-suppressive microenvironment. High neutrophil counts, in particular if of an immature nature, are associated with poor prognosis in cancer patients. Similarly, high monocyte counts are also associated with poor cancer prognosis.
The data demonstrated that, in contrast to Neulasta, Plinabulin did not show NLR>5 or LMR <3.2 values. Promyelocytes or myelocytes were observed in 77% of patients given Neulasta, compared to 14% of patients given Plinabulin (p<0.001), and neutrophil bands were observed in more than 25% of patients given Neulasta, compared to 0% of patients given Plinabulin (p<0.03).
“While both Plinabulin and Neulasta monotherapy demonstrated equal effects in the prevention of CIN in terms of how often and how long patients experienced severe neutropenia in Study 105, this added demonstration of a potentially superior immune profile over Neulasta has distinct advantages. We now recognize the importance of our immune system in fighting cancer, and the avoidance of suppression of our immune system has the potential to result in better cancer outcomes and prognosis. A leading trend is to combine immunotherapy with chemotherapy, and the latter is known to induce CIN. With immune/chemotherapy combination, Plinabulin has the potential to offer advantages over Neulasta and G-CSFs in general for the prevention of CIN, to enable the best possible immune therapeutic efficacy,” said Dr.
“Not only does Plinabulin appear to have immune-enhancing anticancer potential, but there is growing evidence supporting a superior product profile for the prevention of CIN. We previously reported a bone pain benefit with Plinabulin over Neulasta. Plinabulin prevents not only chemotherapy-induced neutropenia, but also chemotherapy-induced thrombocytopenia. This new observation of avoidance of an immune suppressive potential as was observed with Neulasta adds to the list of differentiating features observed in clinical trials to-date for Plinabulin and sets the stage for Plinabulin as a novel CIN treatment with potential for a superior product profile,” added Dr.
About Study 105
Plinabulin was given as a single dose per cycle 30 minutes after docetaxel chemotherapy, while Neulasta was given 24 hours after docetaxel chemotherapy, consistent with its approved product label. The Phase 2 portion met its primary endpoint, which was to determine the recommended Phase 3 Plinabulin dose, and the Phase 3 trial is ongoing.
About Chemotherapy-Induced Neutropenia
The current standard of care for chemotherapy-induced neutropenia prevention is G-CSF monotherapy. However, G-CSF monotherapy has limitations as described in its product information summary. As many as 90 percent of patients on chemotherapy and G-CSF monotherapy may still experience grade 3/4 neutropenia. NCCN guidelines require that patients with grade 3/4 neutropenia decrease chemotherapy dose intensity, delay chemotherapy cycle timing or discontinue chemotherapy, each of which can have a negative effect on the long-term outcomes of cancer care.
Cautionary Note Regarding Forward-Looking Statements
Neulasta is a registered trademark of Amgen, Inc.