Biological activity of most relevant β-glucans investigated in clinical studies
Clinical trial (ref.) | Features | Patients | β-glucans/other drugs | Results |
---|---|---|---|---|
Halstenson CE, et al., [96] | Phase 1a/b.Single center, randomized, double-bind, placebo-controlled, dose escalation study | Healthy volunteer subjects | Imprime PGG | Acceptable safety profile, well tolerated |
NCT03246685 [97] | Phase 2.Multicenter, open-label study | Advanced Squamous Cell Carcinoma of H&N (SCCHN) patients | Imprime PGG & Pembrolizumab | Terminated for enrollment failure |
Uhlik M, et al., [98] | Phase 2.Multicenter, open-label study | 44 ABA positive mTNBC patients | Imprime PGG & Pembrolizumab | mTNBC:- Objective response rate (ORR) was 15.9%, with 1 complete response (CR) and 6 partial responses (PR)- 17/44 shown stable diseases (SD) for more than 1 year (best response) and 4/44 for more than 2 years- Overall survival (OS) rate at 1 year was ~ 63%; median OS is 18.1 months by Kaplaian-Meyer estimation (95% CI, 12 months-not reached) |
Chan A, et al., [99] | Phase 2.Multicenter, open-label study | 40 ABA positive metastatic melanoma patients | Imprime PGG & Pembrolizumab | Melanoma patients:- disease control rate (DCR) was 45% (with 1 CR and 8 SD)- median OS was 8.8 months (with 12 month OS rate equal to 45%) |
Modak S, et al., [100] | Phase 1. | 24 chemo-resistant NB patients | Oral β-glucan & 3F8 | - Acceptable safety profile, well tolerated- The maximum dose tolerated of β-glucan was not reached- A clinical response was observed in 63% of patients |
Kushner BH, et al., [101] | Phase 1. | 15 high-risk NB patients in remission | β-glucan & bivalent gangliosides vaccine | Acceptable safety profile, well tolerated |
NCT03003468 [102] | Phase 1b/2. | mNSCLC patients | Imprime PGG & Pembrolizumab | On going |
NCT03555149 [103] | Phase 1b/2.Open-label, multicenter, randomized Umbrella study | mCRC patients (cohort 3) | Imprime PGG & Atezolizumab (cohort 3) | On going |
mCRC: metastatic CRC; mNSCLC: metastatic NSCLC; mTNBC: metastatic triple-negative breast cancer; NB: neuroblastoma
VC, NR and FT contributed to literature research and article’s selection. VC, NR, FT and FM wrote the manuscript and generated the figures and tables. FM and RB contributed to the revisions of the manuscript. All authors approved the published version of the manuscript.
All authors declare that there are no conflicts of interest.
Not applicable.
Not applicable.
Not applicable.
Not applicable.
Not applicable.
© The Author(s) 2021.