Study summary

Glofitamab added to chemo roughly doubled survival after relapse, but enrolled few US patients

STARGLO trial · 274 people, phase 3 · Published November 2024, The Lancet

What was tested

Glofitamab, a bispecific antibody, added to gemcitabine-oxaliplatin chemotherapy, against chemotherapy with rituximab, for relapsed DLBCL in people who cannot have a stem cell transplant.

What they found

• Median survival was 25.5 vs 12.9 months.
• Most of the trial's patients were enrolled in Asia, not the US.

What it means

The FDA declined to approve this specific use, citing how few US patients were in the trial; glofitamab remains approved only as a later-line single drug.