BEACON Immuno
ITCC-SIOPEN BEACON Immuno: dinutuximab beta added to temozolomide-based chemotherapy for relapsed and refractory high-risk neuroblastoma
Phase 2N = 65NCT02308527
- Population
- Patients with relapsed or refractory high-risk neuroblastoma; 65 randomised between August 2019 and February 2021 at 29 sites in 7 European countries.
- Design
- Open-label, randomised phase 2 trial, 1:2 randomisation to temozolomide-based chemotherapy alone or with dinutuximab beta (10 mg/m2/24 h as a 7-day infusion), with a factorial chemotherapy question (temozolomide versus temozolomide-topotecan) for some patients; crossover to dinutuximab beta with topotecan/cyclophosphamide allowed on progression. Primary outcome best objective response rate during six cycles.
- Primary endpoint
- ORR
- Arms
- Temozolomide-based chemotherapy alone (control, n = 22): Temozolomide (3 patients) or temozolomide-topotecan (19 patients)
- Chemotherapy plus dinutuximab beta (experimental, n = 43): Dinutuximab beta with temozolomide (6 patients) or temozolomide-topotecan (37 patients)
- People
- Gray JC, senior author Moreno L, ITCC and SIOPEN
Δ ORR+12 pointsΔ median PFS+7.3 monthsΔ median OS+8.6 months
Show the numbers
| Endpoint | Analysis | Chemotherapy plus dinutuximab beta | Temozolomide-based chemotherapy alone | Effect |
|---|---|---|---|---|
| ORRRandomised patients (65), efficacy analysed by intention to treatBest objective (complete or partial) response during six cycles of treatment | primaryGray 2026 | 30.2% | 18.2% | 13 of 43 vs 4 of 22 patients. Thirteen of 22 patients in the chemotherapy-alone arm crossed over to dinutuximab beta with cyclophosphamide/topotecan after progression. |
| PFSRandomised patients (65) | primaryGray 2026 | median 11.1 months (4.3–15.5) | median 3.8 months (1.9–7.9) | Secondary outcome. |
| OSRandomised patients (65) | primaryGray 2026 | median 25.7 months | median 17.1 months (7.6–54.6) | Secondary outcome. The 95% CI for the dinutuximab beta arm is 11.4 months to not reached (upper limit not reached, so not entered as an interval). |
| Endpoint | Analysis | Chemotherapy plus dinutuximab beta | Temozolomide-based chemotherapy alone | Effect |
|---|---|---|---|---|
| ORRRandomised patients (65), efficacy analysed by intention to treatBest objective (complete or partial) response during six cycles of treatment | primaryGray 2026 | 30.2% | 18.2% | 13 of 43 vs 4 of 22 patients. Thirteen of 22 patients in the chemotherapy-alone arm crossed over to dinutuximab beta with cyclophosphamide/topotecan after progression. |
| PFSRandomised patients (65) | primaryGray 2026 | median 11.1 months (4.3–15.5) | median 3.8 months (1.9–7.9) | Secondary outcome. |
| OSRandomised patients (65) | primaryGray 2026 | median 25.7 months | median 17.1 months (7.6–54.6) | Secondary outcome. The 95% CI for the dinutuximab beta arm is 11.4 months to not reached (upper limit not reached, so not entered as an interval). |
- Chemotherapy plus dinutuximab beta (experimental)
- Temozolomide-based chemotherapy alone (control)
Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.
Data table (modelled values)
| Months | Chemotherapy plus dinutuximab beta | Temozolomide-based chemotherapy alone |
|---|---|---|
| 0 | 100.0% | 100.0% |
| 7 | 64.6% | 27.9% |
| 14 | 41.7% | 7.8% |
| 21 | 26.9% | 2.2% |
| 28 | 17.4% | 0.6% |
- Chemotherapy plus dinutuximab beta (experimental)
- Temozolomide-based chemotherapy alone (control)
Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.
Data table (modelled values)
| Months | Chemotherapy plus dinutuximab beta | Temozolomide-based chemotherapy alone |
|---|---|---|
| 0 | 100.0% | 100.0% |
| 16 | 65.0% | 52.3% |
| 32 | 42.2% | 27.3% |
| 48 | 27.4% | 14.3% |
| 64 | 17.8% | 7.5% |