Roche Holding AG — Columvi EMA EPAR variation assessment report (EMEA/H/C/005751, 2023)
Roche Holding AG · 2023 · EMA EPAR variation assessment report · company profile →
Report summary
This report summarizes Roche's Type II variation application for Columvi (glofitamab) to treat relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in adults ineligible for autologous stem cell transplant. The application is supported by the pivotal Phase III STARGLO study (GO41944) and supportive Phase Ib study (GO41943), evaluating glofitamab combined with gemcitabine and oxaliplatin (Glofit-GemOx) against rituximab plus GemOx (R-GemOx). Non-clinical data showed superior tumor reduction with the combination. Clinical results from GO41944 demonstrated statistically significant improvements in overall survival (median 25.5 vs. 12.9 months), progression-free survival, and complete response rates for Glofit-GemOx. However, Glofit-GemOx also led to higher rates of adverse events, including cytokine release syndrome, neutropenia, and neurological events, resulting in more treatment discontinuations and deaths. A divergent opinion noted regional efficacy differences and concerns regarding the comparator arm's design.
Key findings — cited to the page
| Patients with at least one thrombocytopenia assessment of Grade >=2 | 39.6 % | · p.34 |
| Patients with at least one lymphopenia assessment of Grade >=2 | 82.8 % | · p.35 |
| Patients with at least one febrile neutropenia event of Grade >=3 | 2.21 % | · p.34 |
| Patients with more than one anaemia assessment of Grade >=2 | 40.6 % | · p.34 |
| Patients with at least one leukopenia assessment of Grade >=2 | 44.4 % | · p.35 |
| Patients with more than one leukopenia assessment of Grade >=2 | 28.3 % | · p.35 |
| Patients with at least one CRS event of Grade >=2 | 13.3 % | · p.33 |
| Patients with more than one CRS event of Grade >=2 | 1.06 % | · p.33 |
| Patients with at least one pneumonia assessment of Grade >=2 | 11.2 % | · p.34 |
| Patients with at least one anaemia assessment of Grade >=2 | 49.2 % | · p.34 |
| Patients with more than one thrombocytopenia assessment of Grade >=2 | 27.3 % | · p.34 |
| Patients with more than one lymphopenia assessment of Grade >=2 | 63.1 % | · p.35 |
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 →