Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Plinabulin · 4 trials · 3 indications
OS is defined as the time from randomization to death from any cause
Duration of severe neutropenia (ANC \< 0.5 × 109/L)
Duration of Grade 4 neutropenia (ANC \< 0.5 × 109/L)
| Arm | Type | Description |
|---|---|---|
| Docetaxel + Plinabulin | EXPERIMENTAL | Participants will receive docetaxel IV infusion on Day 1 of each 21-day cycle plus plinabulin IV infusion on Days 1 and 8. Treatment continues until disease progression, unacceptable toxicity, death, withdrawal, or sponsor/investigator decision. |
| Docetaxel + Placebo | PLACEBO_COMPARATOR | Participants will receive docetaxel IV infusion on Day 1 of each 21-day cycle plus matching placebo IV infusion on Days 1 and 8. Treatment continues until disease progression, unacceptable toxicity, death, withdrawal, or sponsor/investigator decision. |
| Docetaxel (75 mg/m2) + pegfilgrastim (6 mg) + placebo matching plinabulin | ACTIVE_COMPARATOR | Arm 1 |
| Docetaxel (75 mg/m2) + plinabulin (40 mg) + placebo matching pegfilgrastim | EXPERIMENTAL | Arm 2 |
| TAC + Pegfilgrastim (6 mg) | ACTIVE_COMPARATOR | - |
| TAC + Plinabulin 10 mg/m^2 | EXPERIMENTAL | - |
| TAC + Plinabulin 20 mg/m^2 | EXPERIMENTAL | - |
| TAC + Plinabulin 30 mg/m^2 | EXPERIMENTAL | - |
| TAC + Pegfilgrastim (1.5 mg) + Plinabulin (20 mg/m^2) | EXPERIMENTAL | - |
| TAC + Pegfilgrastim (3 mg) + Plinabulin (20 mg/m^2) | EXPERIMENTAL | - |
| TAC + Pegfilgrastim (6 mg) + Plinabulin (20 mg/m^2) | EXPERIMENTAL | - |
| 20 mg/m^2 Plinabulin | EXPERIMENTAL | 75 mg/m\^2 Docetaxel + 20 mg/m\^2 Plinabulin |
| 10 mg/m^2 Plinabulin | EXPERIMENTAL | 75 mg/m\^2 Docetaxel + 10 mg/m\^2 Plinabulin |
| 5 mg/m^2 Plinabulin | EXPERIMENTAL | 75 mg/m\^2 Docetaxel + 5 mg/m\^2 Plinabulin |
| 6 mg Pegfilgrastim | ACTIVE_COMPARATOR | 75 mg/m\^2 Docetaxel + 6 mg Pegfilgrastim |
| Name | Type | Description |
|---|---|---|
| Plinabulin | DRUG | Plinabulin will be administered by IV infusion at 30 mg/m² over approximately 1 hour on Days 1 and 8 of each 21-day treatment cycle. On Day 1, plinabulin will be administered approximately 1 hour after completion of the docetaxel infusion. |
| Docetaxel | DRUG | Docetaxel will be administered by intravenous (IV) infusion at 75 mg/m² over approximately 1 hour on Day 1 of each 21-day treatment cycle. |
| Placebo (matching plinabulin placebo) | DRUG | Matching placebo will be administered by IV infusion over approximately 1 hour on Days 1 and 8 of each 21-day treatment cycle. On Day 1, placebo will be administered approximately 1 hour after completion of the docetaxel infusion. |
| Pegfilgrastim | DRUG | PEGFILGRASTIM is a long-acting granulocyte colony-stimulating factor that stimulates the growth of neutrophils, to reduce the incidence of fever and infection in patients with certain types of cancer who are receiving chemotherapy that affects the bone marrow. |
| Saline Placebo | OTHER | Placebo Syringe 0.6 ml Saline to match the 0.6 ml pegfilgrastim administration |
| D5W Placebo | OTHER | Placebo 250 ml D5W to match the administration of plinabulin diluted in 250 ml D5W |
| Docetaxel, doxorubicin, and cyclophosphamide (TAC) | DRUG | Docetaxel is a type of chemotherapy medicine called an taxane. Doxorubicin is a type of chemotherapy medicine called an anthracycline. Cyclophosphamide is a type of chemotherapy medicine called an alkylating agent. |
Inclusion Criteria: 1. Males and females 18 years of age or older at the time of signing the ICF 2. Willing and able to sign an ICF; 3. Non-squamous NSCLC with EGFR, ALK, ROS and RET wild type who have been diagnosed by histopathological and/or cytological examination as being ineligible for surgic...
Plinabulin is an investigational small molecule being developed for chemotherapy-induced neutropenia and non-small cell lung cancer. It is in Phase 3 clinical development for these indications. The drug is being studied in patients with solid tumors receiving docetaxel myelosuppressive chemotherapy and in advanced or metastatic non-squamous NSCLC.
Plinabulin is an inhibitor that targets multiple tubulin proteins, including TUBB4B, TUBB1, TUBA3C, TUBA4A, TUBB3, and TUBA1A. By inhibiting these tubulin targets, the drug is being investigated for its effects in chemotherapy-induced neutropenia and non-small cell lung cancer.
Plinabulin is being developed by BeyondSpring, Inc., a biopharmaceutical company listed on NASDAQ under the ticker BYSI. The company is conducting clinical trials to evaluate the drug's safety and efficacy in chemotherapy-induced neutropenia and non-small cell lung cancer.
Plinabulin is in Phase 3 clinical development. It has received Breakthrough Therapy designation and Priority Review from the FDA. The drug is investigational and has not been approved, as it is still undergoing clinical trials to assess its efficacy and safety for the studied indications.
Plinabulin has been studied in several clinical trials. NCT03102606 is a Phase 3 trial comparing Plinabulin to pegfilgrastim in patients with solid tumors receiving docetaxel chemotherapy. NCT04227990 is a Phase 2 trial in TAC-induced neutropenia. NCT04345900 is a Phase 2 trial versus pegfilgrastim. NCT07361484 is a Phase 3 trial in NSCLC.
Plinabulin is a distinct investigational drug and is not known to be the same as any other approved medication. It is being studied under its own name in clinical trials for chemotherapy-induced neutropenia and non-small cell lung cancer, and no alternative names have been reported.