Columvi
Oncology· 737 cited findings· 2 source documents
Company: Roche Holding AG
What the regulatory reviews say
Columvi is indicated as a monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. It received an Orphan medicinal product designation (EU/3/21/2497) and a CHMP positive opinion for marketing authorisation on 26 April 2023.
In efficacy findings, the Overall response rate (ORR) was 26%, and the Complete response (CR) rate was 7%. The IRC-assessed CR-rate (ITT population) was 35.2%, and the IRC-assessed CR-rate (efficacy evaluable population) was 36.1%. The median overall survival was 6.3 months. The median duration of CR was not reached, with a median duration of follow-up for IRC-assessed DOCR of 12.8 months. Event-free rates among complete responders were 94.4% at 3 months and 74.6% at 12 months.
The primary safety population size was 154 patients, with a median number of cycles of glofitamab received of 5.0 cycles. The median treatment duration in this population was 79.0 days. In Cohort D3, 63 patients died, and 24 patients experienced disease progression or death.
Key figures — cited to the source page
| Overall response rate (ORR) | 26 % | Roche Holding AG — Columvi EMA EPAR public assessment report, p.11 |
| Complete response (CR) rate | 7 % | Roche Holding AG — Columvi EMA EPAR public assessment report, p.11 |
| Median overall survival | 6.3 months | Roche Holding AG — Columvi EMA EPAR public assessment report, p.11 |
| IRC-assessed CR-rate (ITT population) | 35.2% | Roche Holding AG — Columvi EMA EPAR public assessment report, p.82 |
| Median duration of CR | not reached | Roche Holding AG — Columvi EMA EPAR public assessment report, p.82 |
| Patients died (Cohort D3) | 63 patients | Roche Holding AG — Columvi EMA EPAR public assessment report, p.87 |
| Primary safety population size | 154 patients | Roche Holding AG — Columvi EMA EPAR public assessment report, p.100 |
| CHMP positive opinion for marketing authorisation | 26 April 2023 | Roche Holding AG — Columvi EMA EPAR public assessment report, p.9 |
Source documents
Explore the full evidence
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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.