Roche’s fixed-duration bispecific antibody, Columvi (glofitamab-gxbm), has been granted accelerated approval by the US Food and Drug Administration (FDA) 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) not otherwise specified, or large B-cell lymphoma (LBCL) arising from follicular lymphoma, after two or more lines of systemic therapy.
Around 160,000 people worldwide are estimated to be diagnosed each year with DLBCL – the most common form of non-Hodgkin’s lymphoma. The disease can develop at any age, but the majority patients are diagnosed at age 65 or older.
While the disease is generally responsive to treatment in the front line, 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 a treatment-free period.
The US approval was based on positive results from the phase 1/2 NP30179 study, which evaluated a fixed course of Columvi for 8.5 months in 132 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 patients treated with fixed-duration Columvi reached durable remission, with 56% achieving an overall response and 43% achieving a complete response.
Additionally, more than two-thirds of patients continued to respond for at least nine months, the company said, and the median duration of response was 1.5 years.
Levi Garraway, Roche’s chief medical officer and head of global product development, said: “People with DLBCL who have gone through multiple lines of therapy have a poor prognosis and desperately need additional treatment options.
“As an off-the-shelf, fixed-duration treatment providing durable response rates, we believe Columvi could change the way this aggressive lymphoma is treated, reinforcing our dedication to bringing innovative treatment options to people with critical unmet needs.”