OnCo
trialsTrialPositive

IMROZ

In IMROZ, isatuximab added to VRd cut progression by 40% in older patients not having a transplant.

60-month PFS 63.2% vs 45.2% (HR 0.60); MRD-negative CR 55.5% vs 40.9%. Approved September 2024.

Setting
Newly diagnosed transplant-ineligible myeloma (age ≤80): Isa-VRd vs VRd
Phase
Phase 3
Sponsor
Sanofi
Registry
Headline result
PFS HR 0.60.
Reported
2024
Enrolled
446

Outcomes

1top
In plain words
What these results mean for people, not percentages
446 people took part
Progression-free survival at 60 monthsprimarysurrogate endpoint
  • 63.2 vs 45.2 out of 100 alive without the cancer growing at 60 months with Isa-VRd compared with VRd; 18 more per 100.
  • Roughly one extra person helped for every 6 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
  • Put another way, the treated group had about 40 percent lower chance of the event at any given time (hazard ratio 0.6, likely range 0.41 to 0.88).
  • 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: Newly diagnosed transplant-ineligible myeloma (age ≤80): Isa-VRd vs VRd. 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.

446 participants enrolled.

Progression-free survival at 60 monthsprimary
HR 0.6 (0.41–0.88) · p = 0.0005
Isa-VRd63.2 of 100
n = 265
VRd45.2 of 100
n = 181
Source
EndpointArmnValueHR (95% CI)pSource
Progression-free survival at 60 monthsprimaryIsa-VRd26563.2%0.6 (0.41–0.88)0.0005link
VRd18145.2%

Key papers

1top

Connected

6top

Pages like this

not linked directly; found by shared links