FDA approves Columvi for advanced diffuse large B-cell lymphoma
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The FDA granted accelerated approval to glofitamab-gxbm for treatment of certain adults with relapsed or refractory diffuse large B-cell lymphoma.
The indication applies to patients with DLBCL not otherwise specified or large B-cell lymphoma arising from follicular lymphoma who received at least two prior lines of systemic therapy.
Glofitamab-gxbm (Columvi, Genentech) is a CD20xCD3 T-cell engaging bispecific antibody that is administered for a defined period of time.
The FDA based accelerated approval on results of the phase 1/phase 2 NP30179 study, which included 132 individuals with relapsed or refractory DLBCL. One-third (30%) had received prior chimeric antigen receptor T-cell therapy, and 83% were refractory to their most recent therapy.
Patients received glofitamab-gxbm for a fixed course of 8.5 months.
Outcome measures included complete response rate, duration of response, PFS, safety and tolerability.
More than half (56%) of patients achieved response and 43% achieved complete response. Researchers reported a median response duration of 18.4 months (95% CI, 11.4 to not estimable) and more than two-thirds (68.5%) of responses lasted at least 9 months.
A safety analysis (n = 145) showed 70% of patients developed cytokine release syndrome, with most cases being grade 1 (52%) or grade 2 (14%). Other adverse events included musculoskeletal pain (21%), fatigue (20%) and rash (20%).
Continued approval of glofitamab-gxbm for this indication may be contingent on verification of benefit in a confirmatory trial.
“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,” Krish Patel, MD, director of the lymphoma program at Swedish Cancer Institute in Seattle and an investigator on the NP30179 study, said in a Genentech-issued press 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.”
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