Authors (reference) | Bazinet [7] | Zha [8] | Yu [9] | Yu [10] | Richard-Carpentier [11] | Liu [12] |
---|---|---|---|---|---|---|
Regimen | VEN + ASTX727 | VEN + AZA + chidamide | VEN + AZA + HHT | VEN + AZA + HHT + sorafenib | VEN + enasidenib | VEN + PegC |
Study type | Phase II | Phase II | Retro | Phase II | Phase Ib/II | Phase I |
NCT number | NCT04746235 | N/A | N/A | N/A | NCT04092179 | NCT04666649 |
Study period | N/A | 2022–2023 | 2018–2022 | 2020–2022 | 2020–2022 | N/A |
Patients number | 10 | 53 | 172 | 51 | 23 | 26 |
Male | N/A | 31 (58.5%) | N/A | N/A | 16 (59.3%) | 10 (38.5%) |
Age range (years) | 46–75 | 18–73 | N/A | 31–57 | 23–84 | 24–79 |
Median prior lines of therapies | 2 (1–4) | N/A | N/A | N/A | 1 (1–2) | 2 (1–5) |
Prior exposure to VEN | N/A | N/A | N/A | N/A | N/A | 18 (69.2%) |
Response rate | ORR 50%, CR/CRi 50% | ORR 68%, CRc 53% | CRc 66.3% | ORR 82.4%, CRc 76.5% | ORR 70%, CR 57% | ORR 47% |
Grade ≥ 3 AEs | Neutropenic fever 23% | No | N/A | Neutropenia 92.2% | febrile neutropenia 41% | N/A |
Follow-up (months) | 12.8 | 6.7 | N/A | 10.3 | 17.1 | N/A |
Survival | Median OS 7.6 months, median RFS or DOR 4.6 months | Median EFS 6 months, Median OS not reached | Median OS not reached | Median OS 18.1 months, EFS 13.2 months | Median OS 9.4 months, the 2-year OS rate 42% | N/A |