Plinabulin vs pegfilgrastim,
does it really help with Noninferior duration of severe neutropenia during cycle 1 of docetaxel?
research showsThe grade is C. PROTECTIVE-1 randomized 105 participants in a double-blind, double-dummy phase 3 trial. Cycle-1 duration of severe neutropenia was 0.77 days with plinabulin and 0.25 days with pegfilgrastim. The 0.52-day difference had a 98.52% CI of 0.40 to 0.65 days, meeting the prespecified 0.65-day noninferiority limit at the boundary, but superiority failed. A small, early-stopped, active-control-only noninferiority trial within the manufacturer's development program gives C with 50 points.
ads claimNoninferiority does not mean better prevention than pegfilgrastim. Mean severe-neutropenia duration was actually 0.52 days longer with plinabulin.
Useful facts when choosing a product
- Plinabulin was given on the day of docetaxel and pegfilgrastim the next day.
- Double-dummy masking used matching placebos, but there was no untreated or true placebo control arm.
- The investigational drugs were distinct from the neutrophil-count assessment.
What the research actually shows
Seventeen centers randomized 52 and 53 participants, and every randomized participant received at least one dose, so intention-to-treat and safety populations were both 105. The article describes a "double-blind randomized clinical trial" and a double-dummy comparison of plinabulin plus pegfilgrastim placebo versus pegfilgrastim plus plinabulin placebo. Planned enrollment was 150, but the study stopped at 105 after the planned interim analysis because COVID-19 disrupted patient and sample transport, a resource and logistics limitation. Four design limitations apply: fewer than 200 participants, noninferiority design, active control without a true placebo group, and early stopping. BeyondSpring Pharmaceuticals received China's 13th Five-Year Innovation Grant; its chief medical officer designed the trial and company personnel participated in data collection, analysis, manuscript preparation, and the submission decision. Blayney's institution received BeyondSpring grants and travel support, while Mohanlal and Huang disclosed company stock and patents. A separate statement of free trial-drug supply was not identified, but the confirmed efficacy evidence is entirely from the manufacturer's program.
Why this is classified as C (50)
The prespecified noninferiority margin was met at the boundary, but a surrogate endpoint, manufacturer-only evidence, and multiple design limitations give C with 50 points.
Counterpoint. Convenience and less bone pain may matter separately, but they do not establish superior neutropenia prevention.
Rejudgment record. Cross-check applied — Cross-checked the article, protocol, and registry for the 105-person intention-to-treat set, double-dummy active-control noninferiority design, 0.65-day margin, COVID-19 logistics stop, manufacturer role, and author disclosures
| Endpoint | S | Surrogate marker - laboratory or imaging measures |
| Replication | R1 | Single confirmatory trial |
| Independence | I0 | Evidence comes only from manufacturer studies |
| Effect size | E+ | Meets the clinically important threshold |
The scoring table and the verdict agree (C).
Sub-claim grades by effect
This ingredient is marketed for several effects. A single overall grade blends strong and weak claims together, so each effect is graded separately here. The overall grade reflects the strongest disconfirming or core claim.
| Effect (sub-claim) | Grade | Basis |
|---|---|---|
| Noninferior duration of severe neutropenia versus pegfilgrastim | C | The 0.52-day difference had a rounded upper confidence bound of 0.65 days. |
| Superior prevention versus pegfilgrastim | D | The superiority test failed. |
Cross-check — Codex and Claude
Evidence Table
| Study | Design | Sample | Funding | Endpoint | Result | Weight |
|---|---|---|---|---|---|---|
| Study 1 | Seventeen-center double-blind, double-dummy, active-controlled phase 3 noninferiority randomized trial | 53 | BeyondSpring Pharmaceuticals received a Chinese innovation grant; company personnel participated in design, collection, analysis, writing, and the submission decision | Duration of severe neutropenia in cycle 1 | 0.77 versus 0.25 days, difference 0.52 days (98.52% CI 0.40-0.65); boundary-line success at the 0.65-day noninferiority margin and failed superiority | Manufacturer-only small early-stopped active-controlled noninferiority trial |
Receipt — 1 References
All 1 cited sources were verified for existence at the original page (as of 2026-08-18).
Reviewed and approved: Chamgap Editorial Team · Approval date: 2026-08-18 · Corrections: none
Cite this verdict
[Chamgap] Plinabulin vs pegfilgrastim x docetaxel-induced severe neutropenia — Evidence Grade C·50. 1 cited sources checked. Source: https://chamgap.com/en/verdicts/immunity/plinabulin-vs-pegfilgrastim-docetaxel-severe-neutropenia/ · CC BY 4.0CC BY 4.0 — free to use with attribution; do not distort grades, numbers, or verdict meaning.
What this document does and does not do
Chamgap is an information source. It reports what research has and has not confirmed; it does not tell readers what to take or buy. That decision belongs to readers and, when needed, medical or legal professionals. This verdict reflects literature available up to the search date and may change as new research appears. Nothing here is medical advice.