New NICE technology appraisal guidance has recommended inotuzumab ozogamicin (Besponsa) as a treatment option for relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukaemia in adults. People with relapsed or refractory Philadelphia-chromosome-positive disease should have already been treated with at least one tyrosine kinase inhibitor.
The decision is based on the findings of the INO-VATE 1022 (n=326) open-label, phase 3, randomised controlled trial comparing inotuzumab ozogamicin with fludarabine, cytarabine and granulocyte colony-stimulating factor (FLAG), high-dose cytarabine, and cytarabine with mitoxantrone.
The median overall survival in INO-VATE 1022 was 7.7 months for inotuzumab ozogamicin compared with 6.7 months for standard care in the intention-to-treat population. The difference was not statistically significant.
However, more patients had complete remission or complete remission with incomplete haematological recovery with inotuzumab ozogamicin than with standard care (80.7% vs 29.4%; P<0.0001. Similarly, more patients were able to have haematopoietic stem cell transplant (HSCT) directly after inotuzumab ozogamicin compared with standard care (41% vs 11%; P<0.001).
Based on the results, the appraisal committee concluded that inotuzumab ozogamicin is clinically effective compared with FLAG-based chemotherapy. The treatment was also found to meet NICE's criteria for life-extending treatment at the end of life and cost-effectiveness estimates compared with standard care fell within the range NICE considers an acceptable use of NHS resources.
The recommendation is dependent on the company agreeing to a confidential commercial arrangement regarding cost.
Inotuzumab ozogamicin is administered intravenously at a starting dose of 1.8 mg/m2 per cycle (0.8 mg/m2 on day 1 and 0.5 mg/m2 on days 8 and 15), in three- to four-week cycles. Cycle 1 lasts for three weeks, and each subsequent cycle lasts for four weeks.
