Inotuzumab ozogamicin in adults with relapsed or refractory CD22-positive acute lymphoblastic leukemia: a phase 1/2 study

DeAngelo, Daniel J.; Stock, Wendy; Stein, Anthony S.; Shustov, Andrei R.; Liedtke, Michaela; Schiffer, Charles A.; Vandendries, Erik; Liau, Katherine; Ananthakrishnan, Revathi; Boni, Joseph; Laird, A. Douglas; Fostvedt, Luke; Kantarjian, Hagop M.; Advani, Anjali S.

doi:10.1182/bloodadvances.2016001925

Cited by 108 publications

(115 citation statements)

References 47 publications

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“…[121][122][123][124] Both inotuzumab and blinatumomab, as single agents, resulted in superior CRs, molecular responses, and survival results compared with standardof-care intensive chemotherapy in ALL salvage. This may be the case for inotuzumab, blinatumomab, and other antibodies under development.…”

Section: Acute Lymphocytic Leukemiamentioning

confidence: 99%

Toward the potential cure of leukemias in the next decade

Kantarjian

Keating

Freireich

2018

Cancer

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Historically, progress in leukemia research has been slow, but it has accelerated recently as a result of understanding the pathophysiology of leukemias and implementing more effective and targeted therapies. This review summarizes the progress across leukemia subsets and projects the potential cure of most leukemias in the next decade. Cancer 2018;124:4301-4313.APL constitutes 5% to 10% of AML cases. It is characterized by the translocation between chromosomes 15 and 17-t(15,17)(q22; q12)-and the corresponding promyelocytic leukemia/retinoic acid receptor α (PML-RARα) molecular abnormality. The discovery of daunorubicin and other anthracyclines in the 1970s was the first step toward

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Section: Acute Lymphocytic Leukemiamentioning

confidence: 99%

Toward the potential cure of leukemias in the next decade

Kantarjian

Keating

Freireich

2018

Cancer

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“…Inotuzumab ozogamicin is associated with elevated liver enzyme levels in 11%‐15% of patients, and VOD in 11% of patients . Patients with hepatitis B infection have been excluded from phase II and III studies . To date, no reports of HBV reactivation in patients receiving inotuzumab ozogamicin have appeared in the literature, and there has been no consensus on an appropriate prophylactic strategy.…”

Section: Discussionmentioning

confidence: 99%

Prevention of hepatitis B virus reactivation in patients with hematological malignancies and resolved hepatitis B virus infection: a systematic review and meta‐analysis

Cheung

Law

Chao

et al. 2020

J of Digest Diseases

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Objective Patients with resolved hepatitis B virus (HBV) infection are at risk of HBV reactivation during treatment for hematological malignancies. We conducted a systematic review and meta‐analysis of the data on the efficacy of antiviral prophylaxis for the prevention of HBV reactivation in this group of patients. Methods We conducted a systemic literature search of PubMed including MEDLINE and EMBASE databases to 31 January 2019 to identify studies published in English comparing antiviral prophylaxis with no prophylaxis for HBV reactivation in patients treated for hematological malignancies. The search terms used were (“occult hepatitis B” OR “resolved hepatitis B”) AND (“reactivation”) AND (“haematological malignancy” OR “hematological malignancy” OR “chemotherapy” OR “immunotherapy” OR “chemoimmunotherapy” OR “lymphoma” OR “leukemia” OR “transplant”). The primary outcome was the reactivation of HBV infection. Pooled estimates of relative risk (RR) were calculated. Results We identified 13 relevant studies including two randomized controlled trials (RCT), one post hoc analysis from RCT and 10 cohort studies. There was a trend towards a lower rate of HBV reactivation using antiviral prophylaxis, but the difference was not significant (RR 0.57, 95% confidence interval [CI] 0.23–1.40, P = 0.22). When limiting the analysis to the three prospective studies of patients receiving anti‐CD20 monoclonal antibodies, we found antiviral prophylaxis was associated with a significantly lower risk of HBV reactivation (RR 0.17, 95% CI 0.06–0.49, P = 0.001). Conclusion Antiviral prophylaxis reduced the risk of HBV reactivation in patients receiving anti‐CD20 monoclonal antibodies for hematological malignancies but not in a broader group of patients receiving anticancer therapy.

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“…51 Seventeen (46%) patients were in salvage 1, 9 (24%) in salvage 2, and 11 (30%) in salvage 3 or later. The CR and CR without count recovery rates were 79% (19 of 24) and 46% (6 of 13) in the dose expansion and dose escalation cohorts, respectively.…”

Section: Inotuzumab Ozogamycinmentioning

confidence: 99%

Monoclonal antibodies in acute lymphoblastic leukemia

Jabbour

O’Brien

Ravandi

et al. 2015

Blood

129

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With modern intensive combination polychemotherapy, the complete response (CR) rate in adults with acute lymphoblastic leukemia (ALL) is 80% to 90%, and the cure rate is 40% to 50%. Hence, there is a need to develop effective salvage therapies and combine novel agents with standard effective chemotherapy. ALL leukemic cells express several surface antigens amenable to target therapies, including CD20, CD22, and CD19. Monoclonal antibodies target these leukemic surface antigens selectively and minimize off-target toxicity. When added to frontline chemotherapy, rituximab, an antibody directed against CD20, increases cure rates of adults with Burkitt leukemia from 40% to 80% and those with pre-B ALL from 35% to 50%. Inotuzumab ozogamicin, a CD22 monoclonal antibody bound to calicheamicin, has resulted in marrow CR rates of 55% and a median survival of 6 to 7 months when given to patients with refractory-relapsed ALL. Blinatumomab, a biallelic T cell engaging the CD3-CD19 monoclonal antibody, also resulted in overall response rates of 40% to 50% and a median survival of 6.5 months in a similar refractory-relapsed population. Other promising monoclonal antibodies targeting CD20 (ofatumumab and obinutuzumab) or CD19 or CD20 and bound to different cytotoxins or immunotoxins are under development. Combined modalities of chemotherapy and the novel monoclonal antibodies are under investigation. (Blood. 2015;125(26):4010-4016)

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Inotuzumab ozogamicin in adults with relapsed or refractory CD22-positive acute lymphoblastic leukemia: a phase 1/2 study

Cited by 108 publications

References 47 publications

Toward the potential cure of leukemias in the next decade

Toward the potential cure of leukemias in the next decade

Prevention of hepatitis B virus reactivation in patients with hematological malignancies and resolved hepatitis B virus infection: a systematic review and meta‐analysis

Monoclonal antibodies in acute lymphoblastic leukemia

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