A phase 1b study of atezolizumab in combination with guadecitabine for the treatment of acute myeloid leukemia Journal Article
| Authors: | Prebet, T.; Goldberg, A. D.; Jurcic, J. G.; Khaled, S.; Dail, M.; Feng, Y.; Green, C.; Li, C.; Ma, C.; Medeiros, B. C.; Yan, M.; Grunwald, M. R. |
| Article Title: | A phase 1b study of atezolizumab in combination with guadecitabine for the treatment of acute myeloid leukemia |
| Abstract: | This phase 1 b study evaluated the safety, efficacy, and pharmacokinetics of atezolizumab in combination with guadecitabine in patients with relapsed/refractory (R/R) or first-line acute myeloid leukemia (AML). Patients received atezolizumab 840 mg (days [D] 8 and 22) and guadecitabine 60 mg/m2 (D1 and D5) over 28-day cycles. Sixteen patients (median age 73.0 years) enrolled (R/R cohort, n = 11; first-line cohort, n = 5). All patients reported at least 1 AE; 15 patients (93.8%) reported grade ≥ 3 AEs, and 15 patients (93.8%) reported SAEs. Fourteen of the 16 patients (87.5%) died during the trial period due to disease progression (8/14) or AEs (6/14), hence the study was terminated early. One patient (from the R/R AML cohort) achieved a response (CR with incomplete platelet recovery) with a DOR of 27.8 months at study termination. Atezolizumab plus guadecitabine had limited clinical activity in AML and an overall unfavorable benefit-risk profile at the investigated dose levels. © 2022 Informa UK Limited, trading as Taylor & Francis Group. |
| Keywords: | adult; clinical article; event free survival; aged; leukemia, myeloid, acute; clinical trial; cancer combination chemotherapy; drug efficacy; drug safety; hypertension; hypophosphatemia; risk benefit analysis; antineoplastic agent; anemia; thrombocytopenia; antineoplastic combined chemotherapy protocols; cohort analysis; creatinine; oncology; monoclonal antibody; febrile neutropenia; fever; pneumonia; alanine aminotransferase; aspartate aminotransferase; hypokalemia; maculopapular rash; minimal residual disease; cancer specific survival; comorbidity; sepsis; phase 1 clinical trial; cancer classification; heart left ventricle ejection fraction; karyotype; adverse drug reaction; azacitidine; aspiration pneumonia; pharmacokinetic parameters; demographics; acute myeloid leukemia; overall response rate; failure to thrive; tumor immunogenicity; antibodies, monoclonal, humanized; Common Terminology Criteria for Adverse Events; nutritional disorder; humans; human; male; female; article; checkpoint inhibitor; acute diverticulitis; atezolizumab; guadecitabine; ecog performance status; pharmacodynamic parameters; pd-l1 inhibitor |
| Journal Title: | Leukemia and Lymphoma |
| Volume: | 63 |
| Issue: | 9 |
| ISSN: | 1042-8194 |
| Publisher: | Taylor & Francis Group |
| Date Published: | 2022-01-01 |
| Start Page: | 2180 |
| End Page: | 2188 |
| Language: | English |
| DOI: | 10.1080/10428194.2022.2057484 |
| PUBMED: | 35491816 |
| PROVIDER: | scopus |
| DOI/URL: | |
| Notes: | Article -- Export Date: 1 November 2022 -- Source: Scopus |
