Columvi Plus GemOx May Improve Survival in R/R DLBCL

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The phase 3 STARGLO study met its primary endpoint of improved overall survival, according to Columvi’s manufacturer, Genetech.

DLBCL cells

Patients lived longer when treated with Columvi and GemOx when compared with Rituxan (rituximab) and GemOx.

Treatment with the bispecific antibody Columvi (glofitamab-gxbm) in combination with the chemotherapy drugs gemcitabine and oxaliplatin (a pairing known as GemOx) resulted in survival improvements for patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who had previously received at least one line of therapy and are not candidates for an autologous stem cell transplant, according to a news release from Columvi’s manufacturer, Genetech.

The phase 3 STARGLO study met its primary endpoint of overall survival (the time a patient lives following treatment, regardless of disease status). Patients lived longer when treated with Columvi and GemOx when compared with Rituxan (rituximab) and GemOx, according to the news release, which noted that the study data “will be submitted to health authorities and shared at an upcoming 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,” stated Dr. Levi Garraway, Genentech’s chief medical officer and head of global product development, in the news release. “Building on Columvi’s established benefits, these data demonstrate the potential of this combination regimen to improve survival outcomes in earlier lines of treatment.”

Learn More: Targeted Therapies Shake up the DLBCL Treatment Paradigm, Expert Says

The Food and Drug Administration (FDA) approved Columvi in 2023 for the treatment of adults with R/R DLBCL or for those with large B-cell lymphoma resulting from follicular lymphoma after two or more lines of therapy. The approval made Columvi the first bispecific antibody with a fixed-duration treatment approved for that patient population.

The FDA approved Columvi based on findings from the phase 1/2 NP30179 study.

“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,” Dr. Krish Patel, director of the lymphoma program at the Swedish Cancer Institute in Seattle and investigator of the NP30179 study, said in a news release issued at the time of the approval. “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.”

Columvi, as explained by the National Cancer Institute, is a targeted therapy which works by bringing healthy T cells and lymphoma cells close together so that the T cells can be more effective at killing the lymphoma cells.

The STARGLO study, with 270 participants, began in February of 2021 and is estimated to be completed in April of 2025, according to its listing on clinicaltrials.gov.

The study, according to Genetech, is analyzing overall survival as well as progression-free survival (the time a patient lives without their disease spreading or worsening), objective response rate (the percentage of patients who respond partially or completely to treatment), duration of objective response, safety and tolerability.

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