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An antibody-drug conjugate put four in five relapsed ALL patients into remission versus fewer than one in three with chemotherapy.
INO-VATE ALL, trial NCT01564784 sponsored by Pfizer and published in the New England Journal of Medicine in 2016, showed that the CD22 antibody-drug conjugate inotuzumab ozogamicin put four in five adults with relapsed or refractory B-cell acute lymphoblastic leukaemia into remission versus fewer than one in three with intensive chemotherapy. It randomised 326 patients, met its primary remission endpoint with far higher MRD negativity and four times as many patients proceeding to transplant, while overall survival was not significantly different at the prespecified boundary, and hepatic veno-occlusive disease occurred in about a tenth. Whether lower frontline doses avoid the liver toxicity is the open question.
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 enrolled.
| 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 to 1.03) | 0.04 (did not meet boundary) | link |
| Chemotherapy | 162 | 6.7 months |
Shares Elias Jabbour, Hagop M. Kantarjian, Inotuzumab ozogamicin, CD22.
Shares Inotuzumab ozogamicin, Pfizer (incl. Seagen), Acute lymphoblastic leukaemia, Antibody-drug conjugate (ADC).
Shares Inotuzumab ozogamicin, CD22, Acute lymphoblastic leukaemia.
Shares Inotuzumab ozogamicin, Acute lymphoblastic leukaemia.
Shares CD22, Acute lymphoblastic leukaemia.
Shares CD22, Acute lymphoblastic leukaemia.
Shares Pfizer (incl. Seagen), Antibody-drug conjugate (ADC).
Shares Pfizer (incl. Seagen), Antibody-drug conjugate (ADC).