BeyondSpring has begun a Phase III portion of its Study 105 to analyse Plinabulin for the treatment of chemotherapy-induced neutropenia (CIN) associated with docetaxel, a cytotoxic chemotherapeutic.
The trial aims to enrol around 150 patients with NSCLC, breast or prostate cancer at 55 sites in the US, China, Ukraine, Russia and Hungary.
Under the trial, patients will be randomised to receive either Neulasta or Plinabulin. Protocol of the trial provides for an interim analysis after dosing 100 patients after completing the first cycle of chemotherapy.
Study 105’s primary endpoint is the reduction of neutropenia, measured by DSN, in the first cycle.
Its secondary endpoints include the incidence of neutropenia, febrile neutropenia, incidence and duration of hospitalisation, and incidence of bone pain.
BeyondSpring CEO Dr Lan Huang said: “Initiating the Phase III portion for Study 105 with Plinabulin for CIN prevention is a major milestone for BeyondSpring.
“We believe that a significant reduction in the DSN endpoint, together with a manageable safety profile, would support a successful new drug application for CIN in the US and globally.
“A successful outcome could position Plinabulin to address the majority of high-risk chemotherapy cases, as well as the underserved intermediate-risk chemotherapy patient population.”
CIN is a common side effect of cancer chemotherapies, resulting from the destruction of neutrophils, a type of white blood cell crucial in defence against infection.
Cancer patients who develop CIN are more vulnerable to severe and life-threatening infections. They may have to reduce their chemotherapy treatment, and may require hospitalisation.
Plinabulin has demonstrated its ability to activate GEF-H1, a guanine nucleotide exchange factor, and activates downstream transduction pathways leading to the activation of the protein c-Jun.