STARGLO: Glofitamab Plus Chemo Meets Primary OS End Point in R/R DLBCL in Phase 3 Study

The phase 3 STARGLO study, which is evaluating glofitamab plus chemotherapy in patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), has met its primary overall survival (OS) end point, according to a statement released Sunday by Genentech.

The study (NCT04408638) showed that patients with R/R DLBCL who had a least 1 prior line of therapy and are not candidates for autologous stem cell transplant lived longer when treated with glofitamab, a bispecific antibody, used with gemcitabine and oxaliplatin compared with rituximab and the same chemotherapy combination, according to the statement.

Adverse events (AEs) were consistent with the known safety profiles of the combination, the statement said. The most common AE is cytokine release syndrome.

Glofitamab, sold as Columvi, is a fixed-duration, bispecific CD20-directed CD3 T-cell engager that received accelerated approval from FDA on June 15, 2023, for R/R DLBCL, not otherwise specified, or LBCL arising from follicular lymphoma after at least 2 lines of systemic therapy. The therapy is designed to have 1 region bind to the protein CD3, found on T cells, and 2 regions bind to the protein CD20, found on B cells. The mechanism puts the T cells in closer proximity to the B cells setting off the cancer killing proteins from the T cells.

Approvals from FDA and the European Commission were based on results from a pivotal, single-arm phase 1/2 study of the drug as monotherapy (NCT03075696) in patients with R/R DLBCL who had received at least 2 prior treatments.

In Sunday’s statement, Genentech said these new data will be shared with regulators and presented at an upcoming scientific meeting.

“People with this aggressive lymphoma facing relapse or progression after initial treatment have limited options – particularly those who are ineligible for stem cell transplant,” said Levi Garraway, MD, PhD, Genentech’s chief medical officer and head of Global Product Development. “Building on [glofitamab’s] established benefits, these data demonstrate the potential of this combination regimen to improve survival outcomes in earlier lines of treatment.” 

Reference

Genentech’s Columvi meets primary endpoint of overall survival in people with relapsed or refractory diffuse large B-cell lymphoma in phase III STARGLO study. News release. Genentech. April 14, 2024. Accessed April 15, 2024. https://www.businesswire.com/news/home/20240414728020/en/Genentech%E2%80%99s-Columvi-Meets-Primary-Endpoint-of-Overall-Survival-in-People-With-Relapsed-or-Refractory-Diffuse-Large-B-Cell-Lymphoma-in-Phase-III-STARGLO-Study