Genentech announces STARGLO study meets primary endpoint

Genentech, a member of Roche, announced the Phase III STARGLO study met its primary endpoint of overall survival. The study demonstrated that people with relapsed or refractory, or R/R, diffuse large B-cell lymphoma, or DLBCL, who have received at least one prior line of therapy and are not candidates for autologous stem cell transplant, lived longer when treated with Columvi in combination with gemcitabine and oxaliplatin versus Rituxan in combination with GemOx. Safety of the combination appeared consistent with the known safety profiles of the individual medicines. The data will be submitted to health authorities and shared at an upcoming medical meeting. Columvi was the first fixed-duration bispecific antibody to receive accelerated approval by the FDA and conditional marketing authorization from the European Commission to treat people with R/R DLBCL after two or more lines of systemic therapy. These approvals were based on positive results of Columvi as a monotherapy from the pivotal Phase I/II NP30179 study in patients with R/R DLBCL who had previously received two or more prior treatments. Columvi is a CD20xCD3 T-cell engaging bispecific antibody designed to be off-the-shelf and ready for infusion, so patients can start treatment soon after diagnosis. This is particularly important for patients with highly aggressive disease who are at risk of rapid disease progression. Columvi is given as a fixed-duration treatment, offering people with R/R DLBCL who have failed two or more lines of therapy a treatment end date and the possibility of a treatment-free period, unlike continuous treatments.