A New Option for Relapsed Acute Lymphoblastic Leukemia

Summary and Comment |
July 7, 2016

A New Option for Relapsed Acute Lymphoblastic Leukemia

  1. Michael E. Williams, MD, ScM

Response rates were markedly improved with the antibody-drug conjugate inotuzumab ozogamicin versus standard intensive chemotherapy.

  1. Michael E. Williams, MD, ScM

Adults with relapsed or refractory acute lymphoblastic leukemia (ALL) typically have short survival with currently available therapies. In an industry-sponsored, multicenter, prospective, randomized, phase III trial, investigators compared the single-agent, CD22-targeting antibody-drug conjugate inotuzumab ozogamicin (IO) with standard second-line induction chemotherapy regimens in 326 adult B-cell ALL patients; two thirds had failed one prior induction, and one third had failed two or more. Responding patients could proceed to allogeneic stem cell transplantation (SCT) at the investigator's discretion.

Progression-free survival was increased with IO versus standard re-induction therapy (5.0 vs. 1.8 months; P<0.001), as was overall survival (7.7 vs. 6.7 months; P=0.04). A preplanned analysis of 109 IO recipients and 96 standard therapy recipients (13 declined standard therapy) showed that the complete remission rate was significantly improved with IO (80.7% vs. 33.3%; P<0.001). More IO recipients than standard therapy recipients proceeded to allogeneic SCT (41% vs. 11%; P<0.001). Liver toxicity and veno-occlusive disease (VOD) were increased in IO recipients (11% vs. 1%).


Inotuzumab ozogamicin provides an important new bridge to potentially curative allogeneic SCT in this poor-risk population of B-cell ALL patients. Incorporation of the agent during initial induction or consolidation may be anticipated but will require attention to modulating VOD risk.

Editor Disclosures at Time of Publication

  • Disclosures for Michael E. Williams, MD, ScM at time of publication Consultant / Advisory board Celgene; Gilead; Takeda; TG Therapeutics; Bristol-Myers Squibb Speaker's bureau Research to Practice Grant / Research support Celgene; Janssen; Allos; Pharmacyclics; Gilead Leadership positions in professional societies Lymphoma Research Foundation (Scientific Advisory Board); American Board of Internal Medicine (Chair, Hematology Subspecialty Board; Member, Council)


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