TRANSFORM
The second trial to show a CAR-T beats transplant in early-relapsing large B-cell lymphoma.
EFS median not reached vs 2.4 months (HR 0.36); CR 74% vs 43%. Crossover to liso-cel allowed, confounding OS. Basis for lisocabtagene second-line approval (June 2022).
- Median 29.5 vs 2.4 months with Liso-cel compared with Standard care; about 27.1 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 64 percent lower chance of the event at any given time (hazard ratio 0.36, likely range 0.24 to 0.52).
- This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
- These results apply to the people the trial enrolled: Primary refractory or early-relapsed LBCL, transplant-eligible: liso-cel vs salvage + autologous transplant. 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.
TRANSFORM confirmed ZUMA-7's conclusion with a different CD19 CAR-T and a more permissive design that allowed bridging chemotherapy, making the results closer to real-world practice. Liso-cel's low toxicity makes it attractive for older or frailer patients and for outpatient delivery. Together the two trials made CAR-T the standard second-line therapy for early-relapsing aggressive lymphoma.
ZUMA-7 rewrote second-line treatment for aggressive lymphoma: patients whose disease returns within a year of R-CHOP should be offered CAR-T rather than salvage chemotherapy and transplant. It is also one of the few cell-therapy trials to show an overall survival benefit despite crossover. Patients relapsing later than 12 months were not studied and transplant remains standard for them if chemosensitive.