Plinabulin is under clinical development by BeyondSpring and currently in Phase III for Metastatic Breast Cancer. According to GlobalData, Phase III drugs for Metastatic Breast Cancer have a 47% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Plinabulin’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Plinabulin overview

plinabulin (NPI-2358) is under development for the treatment of non-small cell lung cancer (second and third line), metastatic breast cancer, chemotherapy-induced neutropenia and febrile neutropenia (second line), metastatic brain tumor, Merkle cell cancer , melanoma, small cell lung cancer, glioblastoma multiforme, cancer associated with a RAS mutation such as colorectal cancer, multiple myeloma, bladder cancer. The drug is administered as an intravenous infusion. It is is a halimide derivative. It is a new chemical entity and a synthetic analog of NPI-2350, a natural product isolated from Aspergillus species. It binds to the colchicine-binding site of beta tubulin and GEFH1. It was also under development for metastatic pancreatic cancer, advanced solid tumor malignancies or lymphoma.

BeyondSpring overview

BeyondSpring is a clinical stage biopharmaceutical company that develops immune-oncology cancer therapies. The company provides lead compound, Plinabulin, is derived from a natural compound which holds a number of biochemical activities and provides multiple potential therapeutic potentials in various types of cancers; BPI-002, an oral small molecule agent used for the treatment of colon cancer; BPI-003 and BPI-004 against various tumors. Its target areas include non-small cell lung cancer, neutropenia prevention, and plinabulin with opdivo. The company holds a license from the Fred Hutchinson Cancer Research Center and University of Washington for a range of platform technology which concentrates on a novel mechanism to inhibit a various oncogenes. BeyondSpring is headquartered in New York City, New York, the US.

For a complete picture of Plinabulin’s drug-specific PTSR and LoA scores, buy the report here.


GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.