GSK plc — Jemperli EMA EPAR variation assessment report (EMEA/H/C/005204, 2021)
GSK plc · 2021 · EMA EPAR variation assessment report · company profile →
Report summary
The SCOOP study (213406), a Phase 1 trial evaluating niraparib (Zejula) and dostarlimab (Jemperli) in pediatric patients with recurrent or refractory solid tumors, was prematurely terminated due to safety concerns and insufficient efficacy. No efficacy was observed in expansion cohorts (0% PFS at 6 months in osteosarcoma, 0% ORR in neuroblastoma), and the safety profile was not established. Severe toxicities, including Grade 3/4 thrombocytopenia and immune-mediated encephalitis, were reported. While pharmacokinetic data suggested comparable exposure between pediatric and adult populations for both drugs, the study's early termination prevents drawing definitive conclusions on efficacy or safety for this pediatric population.
Key findings — cited to the page
| Grade 3-4 TEAEs in Part 1A Cohort 1B | 80 % | · p.45 |
| Grade >=3 TEAEs in Part 2 Safety Run-in | 67 % | · p.45 |
| Grade >=3 thrombocytopenia events in Part 1B Cohort 1 | 3 | · p.43 |
| Grade 3-4 TEAEs in Part 1A Cohort 0 | 91 % | · p.45 |
| Grade >=3 TEAEs in Part 1B | 100 % | · p.45 |
| Grade >=3 TEAEs in Part 2B | 71 % | · p.45 |
| Grade >=3 thrombocytopenia events | 6 | · p.43 |
| Grade 3-4 thrombocytopenia | 6 patients | SCOOP · p.6 |
| Grade >=3 thrombocytopenia events in Part 2B | 3 | · p.43 |
| Total Grade >=3 TEAEs of thrombocytopenia or platelet count decreased | 9 | · p.43 |
| Grade 3-4 TEAEs in Part 1A Cohort 1A | 29 % | · p.45 |
| Grade >=3 TEAEs in Part 2A | 45 % | · p.45 |
Source: GSK plc ↗ · 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 →