Glofitamab Injection 格菲妥单抗注射液

Intech announced Phase 3 results of its CD20xCD3 bispecific antibody Columvi (glofitamab-gxbm) as a second-line therapy for diffuse large B-cell lymphoma (DLBCL), showing that the drug combined with chemotherapy can provide survival benefits for patients with relapsed or refractory disease.
The multicenter, open-label, randomized STARGLO trial was designed to evaluate the efficacy and safety of glofitamab plus chemotherapy (i.e., gemcitabine and oxaliplatin) compared with rituximab plus chemotherapy in patients with diffuse large B-cell lymphoma who have received at least one prior therapy and are not eligible for autologous stem cell transplantation.

Patients were randomly assigned in a 2:1 ratio to receive either glofitamab plus chemotherapy or rituximab plus chemotherapy for up to eight 21-day cycles. Patients in the glofitamab group received glofitamab plus chemotherapy, followed by up to four cycles of glofitamab alone, and a single dose of otuzumab was given seven days before the first dose of glofitamab.

The trial met its primary endpoint, overall survival. Secondary endpoints, including progression-free survival, complete response rate, objective response rate, and duration of objective response, were met.

In terms of safety, the safety results shown by Gefituzumab combined with chemotherapy were consistent with the known safety of the individual drugs.

Gefituzumab is a CD20xCD3 T-cell-engaging bispecific antibody with a novel 2:1 structural format that targets CD3 on T cells and CD20 on B cells, inducing T cells to release cancer cell-killing proteins when they interact closely with B cells. It is designed to be ready-to-use and ready for infusion, so patients can start treatment immediately after diagnosis. This is especially important for patients with highly aggressive disease who are at risk of rapid disease progression.

In addition, the drug is the first fixed-duration bispecific antibody to receive accelerated approval from the U.S. FDA and conditional approval from the European Commission for the treatment of patients with relapsed/refractory diffuse large B-cell lymphoma after 2 or more lines of systemic therapy. Fixed-duration treatment is different from continuous treatment and has an end date for treatment and a treatment-free period.

It is worth noting that both the FDA and the European Commission’s regulatory decisions were based on data from the Phase 1/2 NP30179 trial (NCT03075696), which showed an objective response rate of 56% and a complete response rate of 43%. The STARGLO data should help convert its accelerated approval into a full approval.

At present, Genentech has not disclosed the specific results of the STARGLO trial. The company only stated in a press release that subjects who received a combination of gefitinib and chemotherapy lived longer than those who received rituximab plus chemotherapy. The trial data will be submitted to regulators and presented at an upcoming medical conference.

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’, press release. Genentech; published on April 14, 2024.

Note: This article is intended to introduce medical and health research and does not provide any basis for medication. For specific medication guidelines, please consult your attending physician.