Nivolumab (Nivo) maintenance (maint) in high-risk (HR) acute myeloid leukemia (AML) patients.

Authors

null

Tapan M. Kadia

The University of Texas MD Anderson Cancer Center, Department of Leukemia, Houston, TX

Tapan M. Kadia , Jorge E. Cortes , Ahmad Ghorab , Farhad Ravandi , Elias Jabbour , Naval Guastad Daver , Yesid Alvarado , Maro Ohanian , Marina Konopleva , Hagop M. Kantarjian

Organizations

The University of Texas MD Anderson Cancer Center, Department of Leukemia, Houston, TX, The University of Texas MD Anderson Cancer Center, Houston, TX, The University of Texas MD Anderson Cancer Center, Leukemia Department, Houston, TX

Research Funding

Pharmaceutical/Biotech Company

Background: Frontline AML induction produces 60-70% complete remission (CR) rates but relapse is a major source of failure. Beside stem cell transplant (SCT), few options exist for post-CR maint in HR pts. Prior maint studies of cytotoxics were unsuccessful. Post SCT immune surveillance via tumor-specific cytotoxic T-cells may be important in suppressing AML relapse. Immune checkpoint inhibitors may restore host immune surveillance in post-CR maint. Methods: This is a pilot phase II study of nivo maint in HR AML pts in CR, ineligible for SCT. Pts ≥ 18 yrs with a HR feature in 1st CR (CR1) or any pt in 2nd CR (CR2) who received induction &≥ 1 consolidation cycle & were within 12 months (mos) of CR were eligible. Treatment was: nivo 3mg/kg IV Q2 weeks for 6 mos, then Q4 weeks until 12 mos on study, & then Q3 mos until relapse. All pts had baseline cytogenetic (CG) & molecular testing, & minimal residual disease (MRD) assessment by flow cytometry. Blood & marrow samples were collected for immune correlatives. CR duration (CRd) is compared to a similar historical cohort with median (med) of 8 mos. Results: 14 pts (med age 56 yrs): 11 pts were in CR, CRp (1), & CRi (2) at enrollment; 11 pts (79%) were in CR1, 2 pts (14%) in CR2, & 1 pt (7%) in CR4 was treated. Baseline mutations: TP53 (n = 3), DNMT3a (2), IDH2 (2), NPM1 (2), TET2 (3). HR features: 5 (36%) persistent MRD, 4 (29%) adverse CG, 1 (7%) adverse mutation alone, 1 t-AML (7%) & 3 pts (21%) in ≥ CR2. Pts received a med of 4 (1-17) cycles of therapy. At med F/U of 11 mos (1.4 – 26), med CRd was not reached. 6- & 12-mo rates of CRd were 79% & 71%, respectively. The 12- & 18-mo estimated OS were 86% & 67%, respectively. Therapy was well tolerated; 5 pts had grade 3/4 immune-related events. 1 pt had thyroiditis, treated with steroids & hormone replacement; 1 pt with transaminitis responded to dose interruption; 2 pts had pneumonitis treated with steroids & dose interruption. All 4 pts resumed rx after interruption. 1 pt had autoimmune hemolytic anemia & came off study. Most pts have detectable MRD while on therapy & in CR; 1 pt cleared MRD & 1 pt normalized CG. Conclusions: Maint nivo is safe & feasible in HR AML. The study continues to surpass expected rate of 6-mo CRd of HR pts. Correlatives profiling the immune repertoire are being analyzed. Clinical trial information: NCT02532231

Disclaimer

This material on this page is ©2024 American Society of Clinical Oncology, all rights reserved. Licensing available upon request. For more information, please contact licensing@asco.org

Abstract Details

Meeting

2018 ASCO Annual Meeting

Session Type

Poster Discussion Session

Session Title

Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant

Track

Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant

Sub Track

Acute Leukemia

Clinical Trial Registration Number

NCT02532231

Citation

J Clin Oncol 36, 2018 (suppl; abstr 7014)

DOI

10.1200/JCO.2018.36.15_suppl.7014

Abstract #

7014

Poster Bd #

74

Abstract Disclosures