Roche Holding AG — Lunsumio EMA EPAR variation assessment report (EMEA/H/C/005680, 2022)
Roche Holding AG · 2022 · EMA EPAR variation assessment report · company profile →
Report summary
This report details the EMA's variation assessment for Lunsumio (mosunetuzumab), adding new subcutaneous (SC) formulations (5 mg and 45 mg) and a new route of administration for relapsed or refractory follicular lymphoma. The application is based on pharmacokinetic (PK) non-inferiority data from study GO29781, comparing SC and IV monotherapy, supported by study CO41942 and Model-Informed Drug Development. The report covers regulatory, quality, and clinical aspects, confirming the SC formulation's acceptability from a quality perspective and its PK non-inferiority. While efficacy assessments in GO29781 generally favored IV, wide confidence intervals suggest comparability. The SC formulation shows lower rates of Cytokine Release Syndrome (CRS) but higher injection site reactions, with overall comparable efficacy and safety. The report confirms conditional marketing authorization and outlines post-authorization study requirements.
Key findings — cited to the page
| treatment-emergent Grade 4 worsening chemistry laboratory parameter shifts (glucose) | 1.4% | F2 RP2D cohort · p.93 |
| Grade 3-4 AEs (hyperglycaemia) | 2.4% | F2 RP2D cohort · p.93 |
| Grade 3 rash events | 4 | F2 RP2D cohort · p.92 |
| treatment-emergent Grade ≥ 3 worsening chemistry laboratory parameter shifts (glucose) | 15.8% | F2 RP2D cohort · p.93 |
| treatment-emergent Grade 4 worsening chemistry laboratory parameter shifts (phosphate decrease) | 0.7% | F2 RP2D cohort · p.93 |
| Grade 3-4 AEs (hypophosphatemia) | 5.0% | F2 RP2D cohort · p.93 |
| proportion of patients with CRS (any grade) | 32.1% | CO41942 · p.91 |
| proportion of patients with CRS (any grade) | 43.6% | CO41942 · p.91 |
| treatment-emergent Grade ≥ 3 worsening chemistry laboratory parameter shifts (urate) | 21.6% | F2 RP2D cohort · p.93 |
| treatment-emergent Grade 4 worsening chemistry laboratory parameter shifts (urate) | 3.6% | F2 RP2D cohort · p.93 |
| treatment-emergent Grade ≥ 3 worsening chemistry laboratory parameter shifts (phosphate decrease) | 10.1% | F2 RP2D cohort · p.93 |
| Grade 3-5 AEs | 54.7% | SC monotherapy · p.99 |
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 →