European Commission Approves Glofitamab in Relapsed/Refractory DLBCL

Results from the phase 1/2 NP30179 trial led the European Commission to grant conditional marketing authorization to patients with relapsed/refractory diffuse large B-cell lymphoma.

The European Commission has granted conditional marketing authorization for glofitamab-gxbm (Columvi) to be used in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) after 2 or more lines of therapy, according to a press release from Roche.¹

The approval is based on results from the phase 1/2 NP30179 trial (NCT03075696), in which patients who received a fixed course treatment had a complete response (CR) rate of 35.2% and an overall response rate of 50%.^2,3 At 12 months, a continued response was observed in 74.60% (95% CI, 59.19%-89.93%) of complete responders. The median duration of CR was not reached.

The approval stands as Europe’s first CD20xCD3 T cell-engaging bispecific antibody. Glofitamab is a chemotherapy-free option designed to be used for a fixed duration. The press release notes that glofitimab may be an important consideration for treatment strategies in patients at risk of disease progression.

“It is exciting that with this approval, patients in Europe with heavily pre-treated or refractory diffuse large B-cell lymphoma will now have a new, potentially practice-changing treatment option that will allow them time off of therapy to resume their routine activities, helping to alleviate some of the physical and emotional burdens caused by cancer treatment,” principal study investigator Michael Dickinson, MD, PhD, associate professor at the Peter MacCallum Cancer Centre and Royal Melbourne Hospital, said in the press release.

Investigators also reported that the median follow-up for the median duration of response of 12.8 months, and the median time to CR was 42 days (95% CI, 41-47).

Common adverse effects included cytokine release syndrome (CRS; 64.3%), neutropenia (37.7%), anemia (30.5%), and thrombocytopenia (24.7%). Of note grade 1 CRS occurred in 48.1% of patients and grade 2 events were seen in 12.3%, with 1 patient discontinuing treatment following CRS.

In June 2023, the FDA approved glofitamab for patients with relapsed/refractory DLBCL not otherwise specified or large B-cell lymphoma arising from follicular lymphoma after 2 or more lines of systemic therapy.⁴

References

1. European Commission approves Roche’s fixed-duration Columvi (glofitamab) for people with relapsed or refractory diffuse large B-cell lymphoma. News release. Roche. July 11, 2023. Accessed July 13, 2023. https://bit.ly/3JY0EuC
2. Hutchings M, Morschhauser F, Iacoboni G, et al. Glofitamab, a novel, bivalent CD20-targeting T-Cell-engaging bispecific antibody, induces durable complete remissions in relapsed or refractory B-cell lymphoma: a phase I trial. J Clin Oncol. 2021;39(18):1959-1970. doi:10.1200/JCO.20.03175
3. Dickinson MJ, Carlo-Stella C, Morschhauser F, et al. Glofitamab for relapsed or refractory diffuse large B-cell lymphoma. N Engl J Med. 2022;387(24):2220-2231. doi:10.1056/NEJMoa2206913
4. FDA approves Genentech’s Columvi, the first and only bispecific antibody with fixed-duration treatment for people with relapsed or refractory diffuse large B-cell lymphoma. News release. Genentech. June 15, 2023. Accessed July 13, 2023. https://bit.ly/3X7M5dr