STARGLO
A bispecific plus chemotherapy improved survival in relapsed lymphoma, but the FDA rejected it because most patients were enrolled in Asia and the US-relevant subgroup did not clearly benefit.
OS median 25.5 vs 12.9 months (HR 0.62); PFS HR 0.40. EU approval 2025. FDA ODAC voted 8-1 that the data were not applicable to US patients (regional heterogeneity, small non-Asian subgroup); complete response letter July 2025. A landmark case on trial generalisability.
- Median 25.5 vs 12.9 months with Glofit-GemOx compared with R-GemOx; about 12.6 months longer for half the group.
- A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
- Put another way, the treated group had about 38 percent lower chance of the event at any given time (hazard ratio 0.62, likely range 0.43 to 0.88).
- Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
- These results apply to the people the trial enrolled: R/R DLBCL, transplant-ineligible, ≥1 prior line: glofitamab + GemOx vs rituximab + GemOx. People in a different situation may not see the same effect.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
274 participants enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survival (median)primary | Glofit-GemOx | 183 | 25.5 months | 0.62 (0.43–0.88) | — | link |
| R-GemOx | 91 | 12.9 months |
Pages like this
not linked directly; found by shared links- TrialEPCORE DLBCL-1
Shares EPCORE NHL-1: epcoritamab, a subcutaneous CD20 x CD3 bispecific, in relapsed large B-cell lymphoma including after CAR-T, Diffuse large B-cell lymphoma.
- IdeaHead-to-head bispecific vs CAR-T in second-line LBCL
Shares Glofitamab, T-cell engagers (bispecific), Diffuse large B-cell lymphoma.
- ProductOdronextamab
Shares EPCORE NHL-1: epcoritamab, a subcutaneous CD20 x CD3 bispecific, in relapsed large B-cell lymphoma including after CAR-T, T-cell engagers (bispecific), Diffuse large B-cell lymphoma.
- TermRichter transformation
Shares Glofitamab, T-cell engagers (bispecific), Diffuse large B-cell lymphoma.
- TrialEPCORE NHL-1
Shares EPCORE NHL-1: epcoritamab, a subcutaneous CD20 x CD3 bispecific, in relapsed large B-cell lymphoma including after CAR-T, Diffuse large B-cell lymphoma.
- PersonJoshua Brody
Shares T-cell engagers (bispecific), Diffuse large B-cell lymphoma.
- PairingCD20 bispecific + CD79b ADC (mosunetuzumab + polatuzumab)
Shares EPCORE NHL-1: epcoritamab, a subcutaneous CD20 x CD3 bispecific, in relapsed large B-cell lymphoma including after CAR-T, Diffuse large B-cell lymphoma.
- ProductMosunetuzumab
Shares EPCORE NHL-1: epcoritamab, a subcutaneous CD20 x CD3 bispecific, in relapsed large B-cell lymphoma including after CAR-T, T-cell engagers (bispecific), Diffuse large B-cell lymphoma.