Roche’s fixed-duration bispecific antibody Columvi (glofitamab) has been granted conditional marketing authorisation by the European Commission (EC) to treat adults with an aggressive form of lymphoma.
The authorisation specifically applies to patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who have received at least two prior lines of systemic therapy.
Each year in Europe, an estimated 36,000 people are diagnosed with DLBCL, the most common form of non-Hodgkin’s lymphoma.
While the disease is generally responsive to treatment in the frontline, Roche reports that as many as 40% of patients will relapse or have refractory disease, at which time salvage therapy options are limited and survival is short.
Unlike treat-to-progression approaches, where treatment is given indefinitely until the cancer progresses or the therapy cannot be tolerated, Columvi is given for a defined period of time. This gives patients a target end date for their course of treatment as well as the possibility of treatment-free periods.
The EC’s decision was based on positive results from a cohort of the phase 1/2 NP30179 study, which evaluated a fixed course of Columvi in patients with DLBCL who had relapsed or were refractory to prior therapies, including about one-third who had received prior CAR T-cell therapy.
Results showed that Columvi given as a fixed course induced a complete response in 35.2% of patients, and 50% achieved an overall response.
Additionally, 74.6% of those who achieved a complete response continued to respond at 12 months, the company said.
Michael Dickinson, principal study investigator, commented: “As the lead investigator for the NP30179 study, I have seen first-hand the early and long-lasting responses that Columvi can induce, when given to patients for a fixed period of time.
“It is exciting that with this approval, patients in Europe with heavily pre-treated or refractory DLBCL will now have a new, potentially practice-changing treatment option that will allow them time off of therapy to resume their routine activities, helping to alleviate some of the physical and emotional burdens caused by cancer treatment.”
The EU authorisation comes less than a month after Columvi was granted accelerated approval by the US Food and Drug Administration for use in patients with relapsed or refractory DLBCL not otherwise specified, or large B-cell lymphoma arising from follicular lymphoma, after two or more lines of systemic therapy.Πηγή: pmlive.com