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
This report details a Type II variation application for Jemperli (dostarlimab) to expand its indication for primary advanced or recurrent endometrial cancer, based on interim analyses from the RUBY Part 1 study. The study evaluated dostarlimab with carboplatin and paclitaxel, focusing on progression-free survival (PFS) and overall survival (OS) in dMMR/MSI-H and overall populations. Pharmacokinetic, immunogenicity, and exposure-response analyses were also conducted. OS appeared independent of dostarlimab exposure but was influenced by tumor diagnosis. While some safety events (rash, arthralgia) showed exposure relationships, the overall exposure-response for treatment-emergent adverse events was generally flat. The report also details the safety profile of the combination therapy, including deaths, serious adverse events, immune-related adverse events, and laboratory findings across various patient populations and special subgroups.
Key findings — cited to the page
| Dostarlimab/placebo-related Grade ≥3 irAEs | 13.3 % | · p.114 |
| irAEs Grade ≥3 of alanine aminotransferase increased | 2.1 % | · p.114 |
| IRRs related to paclitaxel | 12.9 % | · p.113 |
| Grade ≥3 irAEs | 6.1 % | · p.114 |
| irAEs Grade ≥3 of rash | 4.6 % | · p.114 |
| irAEs Grade ≥3 of rash maculo-papular | 2.5 % | · p.114 |
| Incidence of IRRs related to dostarlimab or placebo | 2.1 % | · p.113 |
| Incidence of IRRs related to dostarlimab or placebo | 0.8 % | · p.113 |
| IRRs related to paclitaxel | 15.4 % | · p.113 |
| Grade ≥3 irAEs | 17.4 % | · p.114 |
| Dostarlimab/placebo-related Grade ≥3 irAEs | 3.3 % | · p.114 |
| irAEs Grade ≥3 of aspartate aminotransferase increased | 2.1 % | · p.114 |
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 →