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 extend its indication for adult patients with dMMR/MSI-H primary advanced or recurrent endometrial cancer, in combination with platinum-containing chemotherapy. Based on the RUBY study, the application fulfills a specific obligation from the initial conditional marketing authorization. The report covers pharmacokinetic/pharmacodynamic modeling, immunogenicity, and clinical pharmacology. Efficacy results from RUBY Part 1 demonstrate significant improvements in progression-free survival and overall survival, particularly in the dMMR/MSI-H population, leading to the conversion of conditional marketing authorization to full approval. The safety profile, including adverse events, was also assessed, supporting a positive benefit-risk assessment.
Key findings — cited to the page
| Not assessable Grade at diagnosis in dostarlimab + carboplatin/paclitaxel arm | 1.9 % | RUBY Part 1 · p.88 |
| Most recent Grade of Disease: Grade 2 in dostarlimab + carboplatin/paclitaxel arm | 28.3 % | RUBY Part 1 · p.88 |
| Grade 2 at diagnosis in dostarlimab + carboplatin/paclitaxel arm | 39.6 % | RUBY Part 1 · p.88 |
| Grade 3 at diagnosis in placebo + carboplatin/paclitaxel arm | 32.3 % | RUBY Part 1 · p.88 |
| Most recent Grade of Disease: Grade 1 in dostarlimab + carboplatin/paclitaxel arm | 18.9 % | RUBY Part 1 · p.88 |
| Most recent Grade of Disease: Grade 1 in placebo + carboplatin/paclitaxel arm | 24.6 % | RUBY Part 1 · p.88 |
| Grade 1 at diagnosis in dostarlimab + carboplatin/paclitaxel arm | 30.2 % | RUBY Part 1 · p.88 |
| Grade 1 at diagnosis in placebo + carboplatin/paclitaxel arm | 29.2 % | RUBY Part 1 · p.88 |
| Grade 2 at diagnosis in placebo + carboplatin/paclitaxel arm | 33.8 % | RUBY Part 1 · p.88 |
| Grade 3 at diagnosis in dostarlimab + carboplatin/paclitaxel arm | 28.3 % | RUBY Part 1 · p.88 |
| Not assessable Grade at diagnosis in placebo + carboplatin/paclitaxel arm | 4.6 % | RUBY Part 1 · p.88 |
| Most recent Grade of Disease: Grade 2 in placebo + carboplatin/paclitaxel arm | 32.3 % | RUBY Part 1 · p.88 |
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 →