The drug has demonstrated the ability to reduce neutropenia induced by chemotherapy without affecting bone marrow or blood-G-CSF levels.
The drug plinabulin, developed by BeyondSpring, continues to demonstrate the ability to successfully treat chemotherapy-induced neutropenia (CIN) caused by multiple chemotherapies, while also suggesting a positive effect on bone marrow cells with a mechanism distinct from G-CSF-based therapies, the current standard of care for CIN.1
CIN is an often-severe side effect that patients with cancer who are undergoing treatment commonly experience involving the eradication of neutrophils, a type of white blood cell. As many as 90% of patients who receive high-risk chemotherapy and G-CSF monotherapy may experience grade 3 or 4 neutropenia.
Plinabulin may also have anti-cancer benefits too, according to Douglas Blayney, MD, professor of medicine and associate division chief of Medical Oncology at Sanford University School of Medicine. In an interview with CURE®, CancerNetwork®’s sister publication, Blayney explained that, “Plinabulin is a small molecule that was isolated from bacteria and slightly modified. It was initially tested as an anti-cancer agent in lung cancer and it was discovered that plinabulin not only had an anti-cancer effect, but also decreased the incidence of neutropenia – it seemed to maintain the white blood count after chemotherapy.”
In a paper published in the journal Cancer Chemotherapy and Pharmacology, the authors reported on plinabulin’s ability to reduce neutropenia induced by docetaxel, cyclophosphamide, or doxorubicin chemotherapy, without affecting bone marrow or blood-G-CSF levels. The results supported earlier clinical testing of plinabulin as a non-G-CSF based treatment for CIN associated with chemotherapies of different mechanisms.
Additionally, plinabulin demonstrated a superior quality of life over pegfilgrastim (Neulasta), the current G-CSF standard of care, in a head-to-head comparison trial for the prevention of neutropenia.2
However, due to their differing mechanisms of action for preventing CIN, researchers are now testing plinabulin and pegfilgrastim in combination.3 The confirmatory phase III of Study 106 currently testing the drugs in partnership could offer exceptional protection against TAC-induced CIN without causing bone pain, compared to pegfilgrastim alone.
“Combining plinabulin with Neulasta not only offers the potential for superior protection against CIN, but also has the potential to optimize chemotherapy for patients through minimizing dose modifications, which are typically imposed by the occurrence of severe CIN,” Blayney, the global principle investigator for Study 106, said in a press release.
The data for phase III of Study 106, as well as a new drug application submission to the FDA, is expected to be released sometime this year.
“Despite the arrival of immunotherapy treatments, chemotherapy is here to stay,” Ramon Mohanlal, BeyondSpring’s Chief Medical Officer and Executive Vice President of Research and Development, said in a press release. “Adding chemotherapy to immunotherapy further enhances the efficacy of immunotherapy, and combination therapies will increasingly dominate in first-line anti-cancer treatments.
The phase III Study 106 abstract was presented at the American Society of Hematology (ASH) Annual Meeting in Orlando, Florida on December 9, 2019.
1. BeyondSpring Publishes Report on Benefits and Mechanism of Plinabulin in Reducing Neutropenia with Multiple Chemotherapies [news release]. New York. Published December 19, 2019. globenewswire.com/news-release/2019/12/19/1962763/0/en/BeyondSpring-Publishes-Report-on-Benefits-and-Mechanism-of-Plinabulin-in-Reducing-Neutropenia-with-Multiple-Chemotherapies.html. Accessed January 13, 2020.
2. Data to be Presented at IASLC 2019 World Conference on Lung Cancer [news release]. New York. Published August 23, 2019. globenewswire.com/news-release/2019/08/23/1905965/0/en/BeyondSpring-s-Plinabulin-Demonstrates-Superior-Quality-of-Life-Over-Pegfilgrastim-in-a-Head-to-Head-Comparison-Trial-for-the-Prevention-of-Neutropenia.html. Accessed January 13, 2020.
3. BeyondSpring’s Study 106 Phase 3 Superior Trial Design Combining Plinabulin with Pegfilgrastim Versus Pegfilgrastim Alone for Chemotherapy-Induced Neutropenia Presented at ASH 2019 Annual Meeting [news release]. New York. Published December 10, 2019. globenewswire.com/news-release/2019/12/10/1958537/0/en/BeyondSpring-s-Study-106-Phase-3-Superior-Trial-Design-Combining-Plinabulin-with-Pegfilgrastim-Versus-Pegfilgrastim-Alone-for-Chemotherapy-Induced-Neutropenia-Presented-at-ASH-2019.html. Accessed January 13, 2020.