[Ad hoc announcement pursuant to Art. 53 LR] Roche’s Columvi meets primary endpoint of overall survival in people with relapsed or refractory diffuse large B-cell lymphoma in Phase III STARGLO study

• Columvi, in combination with chemotherapy, demonstrated a statistically significant improvement in overall survival for people with relapsed or refractory diffuse large B-cell lymphoma
• Data from the STARGLO study will be submitted to health authorities and presented at an upcoming medical meeting

Basel, 15 April 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the Phase III STARGLO study met its primary endpoint of overall survival. The study demonstrated that 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 autologous stem cell transplant, lived longer when treated with Columvi (glofitamab) in combination with gemcitabine and oxaliplatin (GemOx) versus MabThera/Rituxan (rituximab) 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.

“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, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “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 was the first fixed-duration bispecific antibody to receive accelerated approval by the U.S. Food and Drug Administration and conditional marketing authorisation 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.