Glofitamab-gxbm receives FDA approval for relapsing or resistant DLBCL

Glofitamab-gxbm receives FDA approval for relapsing or resistant DLBCL

Source – Roche

Columvi (Glofitamab-gxbm) has been given expedited clearance by the FDA for the treatment of adult patients with diffuse large B-cell lymphoma (DLBCL) that has relapsed or become resistant to treatment or large B-cell lymphoma resulting from follicular lymphoma, following at least two rounds of systemic therapy.

Glofitamab, a CD20xCD3 T-cell engaging bispecific antibody, showed a 56% overall response rate (ORR) and a 43% complete response (CR) rate in the Phase I/II NP30179 study (NCT03075696), which formed the basis for the approval. Additionally, 68.5% of patients who experienced a response persisted in doing so for 9 months or longer. The average response time was 18.4 months (95% confidence interval: 11.4–not estimable).

“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,” study investigator Krish Patel, MD, director of the Lymphoma Program at the Swedish Cancer Institute, stated in a news 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.”

Patients get a single dose of obinutuzumab (Gazyva) as a pretreatment seven days before beginning Glofitamab therapy. As part of their pretreatment, patients also took antipyretics, antihistamines, and corticosteroids to lower their chance of developing cytokine release syndrome (CRS).

Then, until illness progression or intolerance, Glofitamab is provided by 13 intravenous infusions over a maximum of 12 cycles, including step-up dose. Glofitamab is administered after cycle 1 of treatment once every three weeks.

Glofitamab will be marketed in the US in the upcoming weeks, according to Genentech.

Glofitamab was given as a fixed course for 8.5 months to 132 patients with DLBCL who were relapsed or resistant to prior treatment in the multicenter, open-label, dose-escalation, and dose-expansion trial; 30% of patients had previously received CAR T-cell therapy, and 83% were resistant to their most recent treatment.

Regarding security, CRS (70%), musculoskeletal discomfort (21%), weariness (20%), and rash (20%) were the most frequent adverse events (AEs; n = 145). At grades 1 (52%) and 2, CRS was found to be primarily low grade (14%).

The outcomes of a confirmatory study may be required in order for the indication for Glofitamab to maintain its approval.

“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. 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.”

Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development, Genentech

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