In the Phase 3 study, Columvi plus chemotherapy showed a statistically significant improvement in overall survival (OS), progression-free survival (PFS), complete response rate (CRR), and objective response rate (ORR) in people with R/R DLBCL
Genentech building in South San Francisco, California. (Credit: Coolcaesar/Wikipedia)
Genentech, a subsidiary of Swiss drugmaker Roche, announced that the Phase 3 STARGLO study of Columvi plus chemotherapy has met its primary endpoint of overall survival (OS).
The Phase 3 study evaluated Columvi (gemcitabine plus oxaliplatin) in combination with gemcitabine and oxaliplatin (GemOx) compared to Rituxan (rituximab) plus GemOx.
It enrolled people with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), who have received at least one prior line of therapy and are not candidates for stem cell transplant.
The study met its primary endpoint of overall survival (OS), progression-free survival (PFS), complete response rate (CRR), and objective response rate (ORR).
It also met the secondary endpoints of duration of objective response, safety and tolerability.
Genentech said that the treatment with Columvi combination showed safety results that were consistent with the known safety profiles of the individual medicines.
Genentech chief medical officer and global product development head Levi Garraway said: “People with this aggressive lymphoma facing relapse or progression after initial treatment have limited options – particularly those who are ineligible for stem cell transplant.
“Building on Columvi’s established benefits, these data demonstrate the potential of this combination regimen to improve survival outcomes in earlier lines of treatment.”
Columvi is a CD20xCD3 T-cell engaging bispecific antibody designed to be off-the-shelf and ready for infusion, allowing the patients to get treatment immediately after diagnosis.
The drug is designed to target CD3 on the surface of T cells and CD20 on the surface of B cells and activate the release of cancer cell-killing proteins from the T cell.
Columvi has received the US Food and Drug Administration (FDA) accelerated approval and the European Commission (EC) conditional marketing authorisation in people with R/R DLBCL.
The approvals were based on positive results from the Phase 1/2 NP30179 study of Columvi monotherapy in patients with R/R DLBCL who had previously received prior treatments.
Currently, a clinical development program is ongoing, investigating Columvi as a monotherapy and in combination with other medicines for the treatment of B-cell non-Hodgkin’s lymphomas.