FDA Approves Glofitamab-gxbm to Treat Adults With Relapsed/Refractory DLBCL

The FDA has granted accelerated approval to glofitamab-gxbm (Columvi; Genentech) to treat adults with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL) or large B-cell lymphoma arising from follicular lymphoma after at least 2 lines of systemic therapy.¹

This is the first approved bispecific antibody with a fixed-duration treatment for this patient population. DLBCL is the most common form of non-Hodgkin lymphoma, accounting for more than a quarter of all lymphomas reported in the United States.² There are more than 25,000 cases of DLBCL diagnosed each year in the United States.

“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,” Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development, said in a statement.¹ “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.”

Many patients with DLBCL may be responsive to treatment, but the majority of patients who subsequently relapse or are refractory to treatment have poor outcomes.¹

The approval is based on results of the phase 1/2 NP30179 study in which glofitamab was given as a fixed course for 8.5 months. The trial included 132 patients with R/R DLBCL, and 30% of patients in the trial had received prior chimeric antigen receptor T-cell therapy. The majority (83%) had been refractory to their most recent treatment.

“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,” said Krish Patel, MD, director of the Lymphoma Program at the Swedish Cancer Institute in Seattle and investigator of the Columvi phase 1/2 NP30179 study.¹

More than half (56%) of patients in the trial achieved an overall response (95% CI; 47-65) and 43% achieved a complete response (CR; 95% CI; 35-52). In addition, the response was durable with 68.5% of patients who responded continuing to respond for at least 9 months (95% CI; 56.7-80.3). The median duration of response was 18.4 months (95% CI; 11.4-not estimable).

“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,” Patel said.¹

Cytokine release syndrome was the most common adverse event (70%), followed by musculoskeletal pain (21%), fatigue (20%), and rash (20%).

At the 2022 meeting of the American Society of Hematology, research on glofitamab found 61% of patients had maintained a CR 12 months after treatment ended and 92.6% were progression-free.³

The presenter, Martin Hutchings, MD, PhD, staff specialist, Department of Hematology, Copenhagen University Hospital, had said that while more follow-up was needed, “I do believe there is a curative potential."³

References

1. FDA approves Genentech’s Columvi, the first and only bispecific antibody with a fixed-duration treatment for people with relapsed or refractory diffuse large B-cell lymphoma. Press release. June 15, 2023. Accessed June 16, 2023. https://www.gene.com/media/press-releases/14994/2023-06-15/fda-approves-genentechs-columvi-the-firs

2. Diffuse large B-cell lymphoma (DLBCL). Leukemia & Lymphoma Society. Accessed June 16, 2023. https://www.lls.org/research/diffuse-large-b-cell-lymphoma-dlbcl

3. Caffrey M, Klein H. ASH 2022: bispecific antibodies. Am J Manag Care. 2023;29(spec 1):SP22-SP25.TK