FDA Approves Glofitamab (Columvi) for DLBCL

Zosia Chustecka

June 16, 2023

The US Food and Drug Administration (FDA) has granted accelerated approval for glofitamab (Columvi) for use in certain types of lymphoma.

The indication is for use in adult patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified or with large B-cell lymphoma (LBCL) arising from follicular lymphoma who have received two or more lines of systemic therapy.

The product is a T-cell-engaging bispecific antibody developed by Genentech, which has a similar product, mosunetuzumab-axgb (Lunsumio), for the treatment follicular lymphoma. Lunsumio was approved in December 2022.

These drugs could be considered a first choice in the setting of third-line therapy, suggests an expert writing recently in The New England Journal of Medicine.

Nancy Bartlett, MD, from the Siteman Cancer Center, Washington University School of Medicine, St. Louis, Missouri, is the author of an editorial that accompanied the publication of results with glofitamab in the pivotal trial that led to its approval.

"Bispecific agents will be an excellent option for the 60% of patients in whom second-line CAR T-cell therapy fails," she writes in her editorial.

She suggests that these agents may be preferred over CAR T cells. "If longer follow-up confirms that the majority of complete remissions with bispecific agents are durable, on the basis of the advantages of availability (including in the community setting) and more favorable immediate and late toxic-effect profiles, bispecific agents could be considered as the initial choice.... CAR T-cell therapy could be held in reserve for patients who do not have a complete response or who have a relapse after a complete response."

Most Common Form of Non-Hodgkin's Lymphoma

DLBCL is the most common form of non-Hodgkin's lymphoma in the United States, the company noted in a press release. While many people with DLBCL are responsive to treatment, the majority of those who experience relapse or whose condition is refractory to subsequent treatments have poor outcomes.

"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," commented Krish Patel, MD, director of the Lymphoma Program at the Swedish Cancer Institute in Seattle, who is an investigator on the clinical trial that led to the product's approval. He said that the results from trials suggest that glofitamab gives patients "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 accelerated approval is based on response rate and durability of response results from the phase 1/2 NP30179 study.

Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

This trial involved 132 patients with DLBCL who experienced relapse or whose condition was refractory to prior therapies. About one third of patients (30%) had received prior CAR T-cell therapy. Additionally, for 83% of patients, the condition was refractory to their most recent therapy.

Glofitamab was given to all patients as a fixed course for 8.5 months.

More than half (56%) achieved an overall response, and 43% achieved a complete response. Over two thirds (68.5%) of those who responded continued to respond for at least 9 months The median duration of response was 1.5 years.

The most common adverse events were cytokine release syndrome (CRS; 70%), which may be serious or life-threatening; musculoskeletal pain (21%); fatigue (20%); and rash (20%). CRS was generally of low grade (52% of patients experienced grade 1 CRS, and 14% experienced grade 2).

Results from the NP30179 trial were published in December 2022 The New England Journal of Medicine.

The complete response rates seen with glofitamab rivals the durable complete response that has been observed with CAR T-cell therapy, Bartlett notes in the accompanying editorial. "Although these results are promising, it is still too early to estimate the curative potential of glofitamab," she comments.

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