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BeyondSpring Announces Top Line Positive Efficacy and Safety Data from Phase 2 Study 106 with Lead Asset, Plinabulin, for Chemotherapy-Induced Neutropenia Prevention
Plinabulin Significantly Reduced Grade 3/4 CIN and Bone Pain When Combined with Neulasta, Compared to Neulasta Monotherapy, in Breast Cancer Patients Receiving High-Risk TAC Chemotherapy
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The current standard of care (G-CSF agents, including Neulasta and filgrastim), although effective against febrile neutropenia, leaves patients at continued risk for grade 3/4 neutropenia, associated mortality and the need to lower chemotherapy dose intensity to sub-optimally effective levels. In addition, these G-CSF agents cause bone pain in the majority of patients, causing patients to refuse further G-CSF treatment and compromising their ability to receive the most effective chemotherapy regimen.
With TAC chemotherapy, the mean Duration of Severe Neutropenia (DSN) continues to exceed 1 day, associated with grade 3/4 CIN frequency of over 90 percent in patients, leading to a delay in TAC dose, dose reduction or switching to less effective chemotherapy regimens.
Plinabulin is a novel, non-G-CSF agent with a differentiated mechanism of action (MoA) for treating CIN. In contrast to G-CSF, Plinabulin’s MoA is not associated with causing bone pain. The MoA for CIN being different between G-CSF and Plinabulin suggests that there is a strong rationale to combine these two agents together. BeyondSpring’s Phase 2 data from Study 106 demonstrated statistically significant (p<0.05) efficacy of Plinabulin in combination with Neulasta at 6 mg (Plinabulin/Neulasta Combo). Importantly, bone pain caused by Neulasta in more than 90% of patients was almost completely prevented by the addition of Plinabulin (p<0.0001). In addition, Plinabulin attenuated the neutrophil overshoot (absolute neutrophil count over 8.0 x 10E9 cells/L) when added to Neulasta. Neutrophil overshoot can result in bone marrow exhaustion and immune suppression.
In Phase 2 of Study 106, patients were dosed on Neulasta on day 2, and Plinabulin on day 1, 30 minutes after TAC in the following regimens: Neulasta at 6 mg (n=21); Neulasta at 6 mg + Plinabulin (n=16); Neulasta at 3 mg + Plinabulin(n=21); and Neulasta at 1.5 mg + Plinabulin (n=14). The Plinabulin doses were 20 mg/m2.
Key data from the study include the following:
Plinabulin/Neulasta Combo Demonstrated Positive Efficacy Data in Prevention of CIN
Plinabulin/Neulasta Combo Demonstrated Positive Safety Data in Prevention of CIN
“This data suggests a potential new approach to preventing CIN and bone pain in patients receiving chemotherapy. The addition of Plinabulin to the standard TAC and Neulasta regimen appears to markedly reduce the incidence of grade 3/4 neutropenia and nearly eliminates bone pain – which are both serious limitations associated with the use of G-CSF,” said Dr.
“We continue to build on the Plinabulin portfolio for CIN by undertaking multiple studies, involving multiple chemotherapy regimens simultaneously. Previously, we reported positive data regarding Study 105 at prominent scientific conferences (
“Importantly, Plinabulin also exerts anticancer activity, and a large global Phase 3 trial (Study 103) is underway aimed at confirming Plinabulin’s anticancer efficacy when combined with docetaxel. Our overall development strategy for Plinabulin is to improve on the current standard of care for CIN and demonstrate anticancer efficacy by adding Plinabulin to a broad range of standard therapies for oncology. To date, Plinabulin has treated over 450 patients in clinical trials globally, with good tolerability and no cardio-safety issues. We are on track for our planned submission of a New Drug Application (NDA) for the treatment of CIN in
Conference Call and Webcast Information
A live webcast of the conference call will be available through the Investors section of BeyondSpring’s website at http://ir.beyondspringpharma.com. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast. A replay of the webcast will remain available on http://ir.beyondspringpharma.com for 30 days following the call.
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