INO-VATE ALL
An antibody-drug conjugate put four in five relapsed ALL patients into remission versus fewer than one in three with chemotherapy.
CR/CRi 80.7% vs 29.4%; MRD negativity among responders 78.4% vs 28.1%; 41% vs 11% proceeded to transplant; median OS 7.7 vs 6.7 months (HR 0.77), not significant at the pre-specified boundary but with a 2-year OS advantage (22.8% vs 10.0%). NEJM 2016. Hepatic VOD in 11% (22% post-transplant).
Setting
Relapsed or refractory CD22+ B-ALL, adults: inotuzumab ozogamicin vs standard intensive chemotherapy
Phase
Phase 3
Sponsor
Pfizer
Registry
Headline result
CR/CRi 80.7% vs 29.4%; OS 7.7 vs 6.7 months.
Reported
2016
Enrolled
326
Replication
Paediatric ITCC-059 and COG AALL1621 reproduced ~60-80% remission rates; frontline Mini-hyper-CVD + InO series show high MRD negativity in older adults.
In plain words
What these results mean for people, not percentages
Complete remission / CRiprimarysurrogate endpoint
- 80.7 vs 29.4 out of 100 had no sign of cancer on scans or tests with Inotuzumab compared with Chemotherapy; 51.3 more per 100.
- Roughly one extra person helped for every 2 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
- The p-value (<0.001) says a difference this large would rarely happen by chance; it does not say how large or how useful the difference is.
- 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.
Overall survival (median)primarysurvival endpoint
- Median 7.7 vs 6.7 months with Inotuzumab compared with Chemotherapy; about 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 23 percent lower chance of the event at any given time (hazard ratio 0.77, likely range 0.58 to 1.03).
- The likely range for the hazard ratio crosses 1, so the difference could be due to chance.
- Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
Be careful
- These results apply to the people the trial enrolled: Relapsed or refractory CD22+ B-ALL, adults: inotuzumab ozogamicin vs standard intensive chemotherapy. 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.
326 participants enrolled.
Complete remission / CRiprimary
· p <0.001
Inotuzumab80.7 of 100
n = 109
Chemotherapy29.4 of 100
n = 109
Overall survival (median)primary
HR 0.77 (0.58–1.03) · p = 0.04 (did not meet boundary)
Inotuzumab
7.7 mo
Chemotherapy
6.7 mo
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Complete remission / CRiprimary | Inotuzumab | 109 | 80.7% | — | <0.001 | link |
| Chemotherapy | 109 | 29.4% | ||||
| Overall survival (median)primary | Inotuzumab | 164 | 7.7 months | 0.77 (0.58–1.03) | 0.04 (did not meet boundary) | — |
| Chemotherapy | 162 | 6.7 months |
Replication
Paediatric ITCC-059 and COG AALL1621 reproduced ~60-80% remission rates; frontline Mini-hyper-CVD + InO series show high MRD negativity in older adults.