FDA Approves Fixed-Duration Columvi to Treat Relapsed/Refractory DLBCL

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Columvi is the first bispecific antibody that can be administered to patients with relapsed or refractory diffuse large B-cell lymphoma for a defined period of time.

The Food and Drug Administration (FDA) approved Columvi (glofitamab-gxbm) to treat adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) or for those with large B-cell lymphoma resulting from follicular lymphoma after two or more lines of therapy.

This approval marks the first and only bispecific antibody (an antibody that binds to two different antigens at the same time) with a fixed-duration treatment for this patient population, according to a press release from Genentech, the manufacturer of Columvi.

“People with diffuse large B-cell lymphoma who have gone through multiple lines of therapy have a poor prognosis and desperately need additional treatment options,” Dr. Levi Garraway, chief medical officer and head of global product development, said in the release. “As an off-the-shelf, fixed-duration treatment providing durable response rates, we believe Columvi could change the way this aggressive lymphoma is treated.”

The FDA approval of Columvi is based on findings from the phase 1/2 NP30179 study, which assessed the effects of Columvi in patients with relapsed or refractory diffuse large B-cell lymphoma. Of note, 30% of patients were previously treated with CAR-T cell therapy, and 83% of patients did not respond to their most recent therapy. In this study, Columvi was given as a fixed course for 8.5 months, according to the release.

Results from the NP30179 study demonstrated that patients treated with Columvi achieved durable remission, including 56% of patients who achieved an overall response (patients with a partial or complete response to treatment) and 43% obtaining a complete response (the disappearance of all signs of cancer) to therapy.

In addition, 68.5% of patients continued to respond to treatment with Columvi for at least nine months. The median duration of response to Columvi was 1.5 years, according to the release.

“Patients with relapsed or refractory diffuse large B-cell lymphoma may experience rapid progression of their cancer and often urgently need an effective treatment option that can be administered without delay,” Dr. Krish Patel, director of the lymphoma program at the Swedish Cancer Institute in Seattle and investigator of the NP30179 study, said in the release. “Experience from clinical trials demonstrates that Columvi can provide patients with relapsed or refractory diffuse large B-cell lymphoma a chance for complete remission with a fixed-duration immunotherapy and that such remissions can potentially be sustained after the end of their treatment.”

The most common side effects reported in the study included cytokine release syndrome (70%), fatigue (20%), musculoskeletal pain (21%) and rash (20%). Although cytokine release syndrome may be serious or life-threatening, the occurrences of this side effect in the study was generally low-grade, with 52% considered to be mild and 14% considered to be moderate, according to the release.

Columvi is a CD20xCD3 T cell-engaging bispecific antibody given to patients for a defined period of time, according to the release, unlike other treatment approaches where patients are treated either indefinitely or until the patient’s disease progresses.

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