Previously, glofitamab had received an accelerated approval for patients with relapsed or refractory diffuse large B-cell lymphoma who received 2 or more prior lines of systemic therapy.
Trial Name: A Phase III Study Evaluating Glofitamab in Combination With Gemcitabine + Oxaliplatin vs Rituximab in Combination With Gemcitabine + Oxaliplatin in Participants With Relapsed/Refractory Diffuse Large B-Cell Lymphoma
ClinicalTrials.gov ID: NCT04408638
Sponsor: Hoffmann-La Roche
Completion Date (Estimated): April 15, 2025
According to investigators, the phase 3 STARGLO study (NCT04408638) evaluating glofitamab (Columvi; Genentech) had met its primary endpoint of overall survival (OS). The study enrolled patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who had previously received at least 1 line of therapy and are not candidates for autologous stem cell transplant.1
Glofitamab is a CD20xCD3 T-cell engaging bispecfic antibody specifically designed to target the CD3 and CD20 on the surface of T-cells and B-cells, respectively. The dual-targeting brings the T-cell in close proximity to the B-cell, activating the release of proteins that kill cancer cells from the T-cell. It was the first fixed-duration bispecific antibody to receive an accelerated approval by the FDA.1
The accelerated approval that glofitamab received in June 2023 was after positive response rates and durability of response in the phase 1/2 NP30179 study. About 130 patients with DLBCL who enrolled in this study were R/R to prior therapies, and approximately 30% had previously received chimeric antigen receptor T-cell therapy. The results for this trial demonstrated that among the patients who received fixed-duration glofitamab, about 56% had achieved an overall response and 43% achieved a complete response. Further, approximately 68.5% of this patient population had also continued to respond to treatment for at least 9 months.2
“Patients with R/R DLBCL may experience rapid progression of their cancer and often urgently need an effective treatment option that can be administered without delay,” said study investigator Krish Patel, MD, director of the Lymphoma Program at the Swedish Cancer Institute in Seattle, Washinton. “Experience from clinical trials demonstrates that [glofitamab] can provide patients with R/R DLBCL a chance for complete remission with a fixed-duration immunotherapy and that such remissions can potentially be sustained after the end of their treatment.”2
The STARGLO study is a multicenter, open-label, randomized phase 3 trial that evaluated the efficacy and safety of glofitamab compared with hyaluronidase plus rituximab (MabThera/Rituxin; Genentech) in patients with R/R DLBCL who have received at least 1 prior line of therapy and who are not candidates for autologous stem cell transplant. Patients were randomly assigned to receive either intravenous (IV) glofitamab in combination with IV gemicitabine plus oxaliplatin (GemOx) or an IV rituximab combination regimen with IV GemOx in a 21-day cycle.1
The primary endpoint is OS, and secondary endpoints include progression-free survival (PFS), complete response rate, objective response rate, duration of objective response. Safety and tolerability of the drug was also measured.1
The safety of the combination regimen had also appeared consistent with the known profiles of the individual medicines. Further, glofitamab is currently also being investigated as a monotherapy as well as in combination with other drugs, such as polatuzumab vedotin (Polivy; Genentech), in earlier lines of treatment for patients with B-cell non-Hodgkin lymphomas—such as DLBCL—and other blood cancers.1
“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, CMO, head of Global Product Development at Roche, in a press release. “Building on [glofitamab’s] established benefits, these data demonstrate the potential of this combination regimen to improve survival outcomes in earlier lines of treatment.”1
