Real-World Outcomes of Adult B-Cell Acute Lymphocytic Leukemia Patients Treated With Inotuzumab Ozogamicin

Badar, Talha; Szabó, Anikó; Wadleigh, Martha; Liedtke, Michaela; Arslan, Shukaib; Siebenaller, Caitlin; Aldoss, Ibrahim; Schultz, Elizabeth; Hefazi, Mehrdad; Litzow, Mark R.; Kuo, Eric; Wang, Amy; Curran, Emily; Shallis, Rory M.; Podoltsev, Nikolai A.; Balasubramanian, Suresh Kumar; Yang, Jay; Mattison, Ryan J.; Burkart, Madelyn; Dinner, Shira; Advani, Anjali S.; Atallah, Ehab

doi:10.1016/j.clml.2020.03.004

Cited by 17 publications

(16 citation statements)

References 20 publications

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“…Some retrospective real‐world studies of patients with R/R ALL treated with IO showed CR/CRi rates between 53% and 69%, with MRD negative response of 45%–79%, being similar to that observed in our series. However, the median CR duration and the OS in our study were shorter compared with other real‐life studies, in which the OS ranged from 6.9 to 11.7 months 15,16 . The median PFS in our cohort was 3.5 months, being slightly shorter than that observed in the INO‐VATE trial (5 months) 5 .…”

Section: Discussioncontrasting

confidence: 78%

Results of the compassionate program of inotuzumab ozogamicin for adult patients with relapsed or refractory acute lymphoblastic leukemia in Spain

Torrent,

Morgades,

García‐Calduch

et al. 2023

European J of Haematology

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Introduction The prognosis of relapsed B cell precursor acute lymphoblastic leukemia (B‐ALL) is poor and few patients can be successfully rescued with conventional therapies. Inotuzumab ozogamicin (IO), an antibody against the CD22 antigen linked to calicheamicin, has been approved as a rescue treatment in relapsed/refractory (R/R) B‐ALL. Patients and Methods This was an observational, retrospective, multicenter study of adult patients included in the Spanish program of compassionate use of IO in centers from the PETHEMA group (Programa Español de Tratamientos en Hematología). Results Thirty‐four patients with a median age of 43 years (range, 19–73) were included. Twenty patients (59%) were refractory to the last treatment, IO treatment was given as ≥3rd salvage treatment in 25 patients (73%) and 20 patients (59%) received allogeneic hematopoietic stem cell transplantation before IO treatment. After a median of 2 cycles of IO, 64% of patients achieved complete response (CR)/complete response with incomplete recovery. The median response duration, progression‐free survival and overall survival (OS) were 4.7 (95%CI, 2.4–7.0 months), 3.5 (95%CI, 1.0–5.0 months) and 4 months (95%CI, 1.9–6.1 months) respectively, with better OS for patients with relapsed B‐ALL versus refractory disease (10.4 vs. 2.5 months, respectively) (p = .01). There was a trend for better OS for patients with first CR duration >12 months (7.2 months [95%CI, 3.2–11.2] vs. 3 months [95% CI, 1.8–4.2] respectively) (p = .054). There was no sinusoidal obstruction syndrome (SOS) event during IO treatment, but three patients (9%) developed grade 3–4 SOS during alloHSCT after IO treatment. Conclusions Our study showed slightly inferior outcomes of the pivotal trial probably due to poorer risk factors and late onset of IO therapy of recruited patients. Our results support early use of IO in relapsed/refractory ALL patients.

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Section: Discussioncontrasting

confidence: 78%

Results of the compassionate program of inotuzumab ozogamicin for adult patients with relapsed or refractory acute lymphoblastic leukemia in Spain

Torrent,

Morgades,

García‐Calduch

et al. 2023

European J of Haematology

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“…Patients are now able to attain longer and deeper remissions with these NAs in comparison with traditional chemotherapy. Moreover, blinatumomab and InO have been shown to outperform conventional chemotherapy in successfully bridging patients to allogeneic hematopoietic stem cell transplantation (allo‐HCT) and achieving long‐term disease control 7‐10 …”

Section: Introductionmentioning

confidence: 99%

Sequencing of novel agents in relapsed/refractory B‐cell acute lymphoblastic leukemia: Blinatumomab and inotuzumab ozogamicin may have comparable efficacy as first or second novel agent therapy in relapsed/refractory acute lymphoblastic leukemia

Badar

Szabó

Dinner³

et al. 2020

Cancer

Self Cite

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Background The availability of novel agents (NAs), including blinatumomab and inotuzumab ozogamicin (InO), has improved the outcomes of patients with relapsed/refractory (RR) B‐cell acute lymphoblastic leukemia (ALL). Because of the relative effectiveness, it is often a challenge for clinicians to determine how to best sequence these NAs with respect to efficacy and toxicity. Methods In this multicenter, retrospective study of patients with RR ALL treated with blinatumomab, InO, or both, their efficacy as a first or second NA was compared. Results Among 276 patients, 221 and 55 received blinatumomab and InO, respectively, as a first NA therapy. The complete remission (CR)/complete remission with incomplete count recovery (CRi) rate was 65% and 67% for the blinatumomab and InO groups, respectively (P = .73). The rate of treatment discontinuation due to adverse events was 4% and 7% in the blinatumomab and InO groups, respectively. Ninety‐two patients (43%) in the blinatumomab group and 13 patients (29%) in the InO group proceeded with allogeneic hematopoietic stem cell transplantation. The median overall survival (OS) was 15 and 11.6 months in the blinatumomab and InO groups, respectively. A subset analysis was performed for 61 patients who received both NAs (blinatumomab and then InO [n = 40] or InO and then blinatumomab [n = 21]). The CR/CRi rate was 58% for patients who received InO as the second NA and 52% for patients who received blinatumomab as the second NA. The median OS was 10.5 for patients who received InO as the second NA and 5.9 months for patients who received blinatumomab as the second NA (P = .09). Conclusions Although the limited power of this study to detect a significant difference between subgroups is acknowledged, the data suggest that blinatumomab and InO may have comparable efficacy as a first or second NA therapy in RR ALL.

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“…To assess the efficacy of Besponsa in a less stringently controlled ("real world") patient cohort, in 2020 Badar et al reported on the clinical response and adverse effects in 84 R/R ALL patients who received the ADC outside of clinical trials. [87] Overall response rate (complete remission/complete remission with incomplete count recovery) was 63%; 44% had complete remission with minimal residual disease negativity. In those not requiring ASCT, the median duration of response was 51% at 2 years.…”

Section: Clinical Efficacymentioning

confidence: 91%

Antibody‐Drug‐Conjugate Therapy for Hematological Cancers: Matching Cell Biology with Clinical Benefit

Firer

Luboshits

2021

Adv Funct Materials

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Progress in the development and clinical efficacy of antibody-drug conjugates (ADCs) has attracted the interests of both academic researchers and the industry. The rationale for developing ADCs is based on the inherent nonselectivity of chemotherapy for tumor cells, leading to side effects that can be severe and life threatening. Another major consequence of chemotherapy is the development of drug resistance. For these reasons, targeted drug delivery (TDD) systems are being developed to specifically deliver the cytotoxic drug into the target cell. A variety of carriers that can deliver drugs to the surface or into cancer cells, one of which is the use of monoclonal antibodies, with to date ten ADCs having received FDA approval. This review will focus on the development and clinical application of five ADCs currently approved for the treatment of hematological malignancies. Following a short history that led to their regulatory approval, the review will focus on the important link between the biology of the ADC, the cell surface component targeted by the antibody component, and clinical efficacy and conclude by highlighting newer developments that strengthen this link, so that ADCs can provide long-term clinical benefit to patients with hematological cancers.

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Real-World Outcomes of Adult B-Cell Acute Lymphocytic Leukemia Patients Treated With Inotuzumab Ozogamicin

Cited by 17 publications

References 20 publications

Results of the compassionate program of inotuzumab ozogamicin for adult patients with relapsed or refractory acute lymphoblastic leukemia in Spain

Results of the compassionate program of inotuzumab ozogamicin for adult patients with relapsed or refractory acute lymphoblastic leukemia in Spain

Sequencing of novel agents in relapsed/refractory B‐cell acute lymphoblastic leukemia: Blinatumomab and inotuzumab ozogamicin may have comparable efficacy as first or second novel agent therapy in relapsed/refractory acute lymphoblastic leukemia

Antibody‐Drug‐Conjugate Therapy for Hematological Cancers: Matching Cell Biology with Clinical Benefit

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