Trial data on the use of plinabulin for mitigating chemotherapy-induced neutropenia with docetaxel will be presented as a poster at the American Society of Hematology’s annual meeting in San Diego.
Trial data on the use of plinabulin for mitigating chemotherapy-induced neutropenia with docetaxel will be presented as a poster at the American Society of Hematology’s annual meeting in San Diego.
Current therapies for the treatment of neutropenia cannot be administered until 24 hours after chemotherapy. During that time, there may be significant destruction of the white blood cells (neutrophils) that are a patient’s first line of defense against infections, according to Ramon Mohanlal, MD, PhD, chief medical officer at BeyondSpring, which developed plinabulin.
“Whereas Plinabulin can be administered on the same day as (1 hour after) chemotherapy,” he said in a statement. “The phase 2 data shows that Plinabulin has a profound benefit in preventing docetaxel-induced neutropenia (P <.0003) while demonstrating a favorable safety profile (much less bone pain vs G-CSF and its analogues). It also has the added benefit of having anticancer effects."
In the trial, patients were randomized to receive docetaxel 75 mg/m2 alone (n = 73) or docetaxel 75 mg/m2 followed by plinabulin at 30 mg/m2 (n = 50) or at 20 mg/m2 (n = 40). The treatments were repeated every 3 weeks, and plinabulin was given by a 30-minute intravenous infusion starting 1 hour after the patient was given docetaxel.
The study found that the addition of plinabulin to docetaxel, compared with docetaxel alone, significantly reduced the proportion of patients with grade 4 neutropenia (an abnormally low concentration of neutrophils in the blood) from 33.3% to 4.6%. Grade 4 neutropenia is associated with a high mortality rate, and patients with grade 4 neutropenia are more susceptible to severe bacterial infections and sepsis, which require hospitalizations.
"We are making excellent progress as we complete these pivotal studies on the efficacy of the plinabulin/docetaxel combination in preventing neutropenia during chemotherapy," said Lan Huang, PhD, co-founder and CEO of BeyondSpring. "Plinabulin has the potential to be a more effective, safe, and convenient alternative to G-CSFs (including its biosimilars and pegylated G-CSF), while also being a more affordable solution to the benefit of cancer patients in need all over the world."
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