GSK plc — Jemperli EMA EPAR public assessment report (EMEA/H/C/005204, 2021)
GSK plc · 2021 · EMA EPAR public assessment report · company profile →
Report summary
The EMA granted conditional marketing authorization for Jemperli (dostarlimab) for recurrent or advanced dMMR/MSI-H endometrial cancer, addressing an unmet medical need. The application, submitted by GlaxoSmithKline, was supported by comprehensive quality, non-clinical (pharmacology, PK, toxicology), and clinical data from the GARNET study. Dostarlimab demonstrated a favorable benefit-risk profile, with a 43.5% objective response rate and durable responses. Its safety profile, consistent with other PD-1 inhibitors, showed common adverse events like fatigue and nausea, with immune-related adverse events being a key concern. Further data from GARNET and RUBY studies are required to confirm efficacy and safety, with post-authorization studies mandated by December 2022. Risk management and educational programs are also in place.
Key findings — cited to the page
| Grades 3-4 Pruritus incidence | 0.2 % | · p.139 |
| All Grades Pruritus incidence | 11.5 % | · p.139 |
| Grades 3-4 Rash incidence | 1.2 % | · p.139 |
| All Grades Myalgia incidence | 6.6 % | · p.139 |
| All Grades Rash incidence | 16.5 % | · p.139 |
| Grades 3-4 Arthralgia incidence | 0.6 % | · p.139 |
| All Grades Nephritis incidence | 0.8 % | · p.139 |
| All Grades Pyrexia incidence | 10.5 % | · p.140 |
| Grades 3-4 Pyrexia incidence | 0.2 % | · p.140 |
| All Grades Chills incidence | 3.7 % | · p.140 |
| All Grades Arthralgia incidence | 13.8 % | · p.139 |
| Grades 3-4 Anaemia incidence | 8.7 % | · p.139 |
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 →