Roche Holding AG — Tecentriq EMA EPAR variation assessment report (EMEA/H/C/004143, 2017)
Roche Holding AG · 2017 · EMA EPAR variation assessment report · company profile →
Report summary
This report summarizes the assessment of Roche Holding AG's Tecentriq (atezolizumab) paediatric studies, specifically Cohort D of the BO41932 (TAPISTRY) Phase II trial. This study investigated atezolizumab in adult and paediatric patients with TMB-high advanced or metastatic solid tumours. The primary endpoint, objective response rate, was achieved, and the safety profile was consistent with previous findings, revealing no new safety concerns.
Key findings — cited to the page
| Patients with at least one Grade 3-5 AE | 45.3 % | BO41932 (TAPISTRY) Cohort D · p.13 |
| Patients with at least one AE of any grade | 93.2 % | BO41932 (TAPISTRY) Cohort D · p.12 |
| Patients with at least one treatment-related Grade 3-5 AE | 9.5 % | BO41932 (TAPISTRY) Cohort D · p.13 |
| Patients reporting Grade 5 AEs | 4.1 % | BO41932 (TAPISTRY) Cohort D · p.13 |
| Number of patients treated | 148 patients | BO41932 (TAPISTRY) Cohort D · p.7 |
| Safety Evaluable Population | 148 patients | BO41932 (TAPISTRY) Cohort D · p.7 |
| Atezolizumab dose (adults) | 1200 mg | BO41932 (TAPISTRY) Cohort D · p.5 |
| 95% CI lower bound for IRC-assessed ORR | 16.53 % | BO41932 (TAPISTRY) Cohort D · p.8 |
| Number of patients enrolled | 150 patients | BO41932 (TAPISTRY) Cohort D · p.5 |
| 95% CI upper bound for IRC-assessed ORR | 33.10 % | BO41932 (TAPISTRY) Cohort D · p.8 |
| Number of responders in TMB-high (≥16 mutations/Mb) EE population | 27 responders | BO41932 (TAPISTRY) Cohort D · p.8 |
| IRC-assessed ORR in TMB-high (≥16 mutations/Mb) EE population | 24.1 % | BO41932 (TAPISTRY) Cohort D · p.8 |
Source: Roche Holding AG ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →