Lunsumio(mosunetuzumab)
Oncology· 501 cited findings· 2 source documents
Company: Roche Holding AG
What the regulatory reviews say
Lunsumio (mosunetuzumab) is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least two prior systemic therapies. The European Medicines Agency (EMA) granted an orphan medicinal product designation (EU/3/21/2517) and agreed to an Accelerated Assessment procedure on 16 September 2021. A conditional marketing authorisation was requested.
Efficacy findings from the GO29781 clinical trial include a median Progression-Free Survival (PFS) of 1-1.1 years for third-line R/R FL patients and 0.5 years for sixth-line R/R FL patients. Median Overall Survival (OS) was 4.8-8.8 years for third-line R/R FL patients and 1.9 years for sixth-line R/R FL patients. The Complete Response (CR) rate by Independent Review Facility (IRF) was 58.5% in the F2 expanded R/R FL cohort and 60.0% in the B11 expanded R/R FL cohort.
Safety data indicate that Grade ≥3 Cytokine Release Syndrome (CRS) occurred in <3% of patients. Discontinuation due to progressive disease was observed in 23.4% of the F2 expanded R/R FL cohort and 27.8% of the B11 expanded R/R FL cohort. Deaths by any cause were 11.7% (11 patients) in the F2 expanded R/R FL cohort and 8.9% (8 patients) in the B11 expanded R/R FL cohort.
Key figures — cited to the source page
| Median PFS for third-line R/R FL patients | 1-1.1 years | Roche Holding AG — Lunsumio EMA EPAR public assessment repor, p.11 |
| Median PFS for sixth-line R/R FL patients | 0.5 years | Roche Holding AG — Lunsumio EMA EPAR public assessment repor, p.11 |
| Median OS for third-line R/R FL patients | 4.8-8.8 years | Roche Holding AG — Lunsumio EMA EPAR public assessment repor, p.11 |
| CR rate by IRF (F2 exp R/R FL cohort) | 58.5% | Roche Holding AG — Lunsumio EMA EPAR variation assessment re, p.70 |
| CR rate by IRF (B11 exp R/R FL cohort) | 60.0% | Roche Holding AG — Lunsumio EMA EPAR variation assessment re, p.70 |
| Grade ≥3 CRS frequency | <3 % | Roche Holding AG — Lunsumio EMA EPAR public assessment repor, p.164 |
| Discontinuation due to progressive disease (F2 exp R/R FL cohort) | 23.4% | Roche Holding AG — Lunsumio EMA EPAR variation assessment re, p.56 |
| Proposed indication | treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least two prior systemic therapies | Roche Holding AG — Lunsumio EMA EPAR public assessment repor, p.7 |
Source documents
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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.