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Attend this session at the
2019 ASCO Annual Meeting!


Session: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant

Type: Poster Session

Time: Monday June 3, 8:00 AM to 11:00 AM

Location: Hall A


Session: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant

Type: Poster Discussion Session

Time: Monday June 3, 4:30 PM to 6:00 PM

Location: E450

The first-in-class anti-CD47 antibody Hu5F9-G4 is active and well tolerated alone or with azacitidine in AML and MDS patients: Initial phase 1b results.

Sub-category:
Acute Leukemia

Category:
Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant

Meeting:
2019 ASCO Annual Meeting

Abstract No:
7009

Poster Board Number:
Poster Discussion Session (Board #384)

Citation:
J Clin Oncol 37, 2019 (suppl; abstr 7009)

Author(s): David Andrew Sallman, William Bruce Donnellan, Adam Steven Asch, Daniel Junseung Lee, Monzr Al Malki, Guido Marcucci, Daniel Aaron Pollyea, Suman Kambhampati, Rami S. Komrokji, Joanna Van Elk, Ming Lin, Balaji Agoram, James Y Chen, Jens-Peter Volkmer, Chris H.M. Takimoto, Mark Chao, Paresh Vyas; Moffitt Cancer Center, Tampa, FL; Sarah Cannon Research Institute, Nashville, TN; Brody School of Medcn, Greenville, NC; Columbia Univ Medcl Ctr, New York, NY; City of Hope Medical Center, Duarte, CA; Ohio State Univ, Columbus, OH; University of Colorado Comprehensive Cancer Center, Aurora, CO; University of Kansas Medical Center, Westwood, KS; Forty Seven, Inc., Menlo Park, CA; Forty Seven, Menlo Park, CA; Jansen, Menlo Park, CA; University of Oxford, Oxford, United Kingdom

Abstract Disclosures

Abstract:

Background: Hu5F9-G4 (5F9) is an antibody targeting CD47, a macrophage immune checkpoint and “don’t eat me” signal on cancers. CD47 blockade induces tumor phagocytosis and eliminates leukemia stem cells (LSC) in AML models. Azacitidine (AZA) synergizes with 5F9 by inducing “eat me” signals on AML, enhancing phagocytosis. This trial explored the safety/efficacy of 5F9 alone or with AZA in AML/MDS patients (pts). Methods: This Phase 1b treated: r/r AML/MDS pts with 5F9; and untreated AML (induction chemo ineligible) and higher risk MDS pts with 5F9+AZA. A 5F9 priming/intrapatient dose escalation regimen (1-30 mg/kg weekly) was used to mitigate on target anemia. Results: 10 (6 AML, 4 MDS) r/r pts received 5F9 (median 2 prior therapies (range 1-6). 24 untreated pts (15 AML, 9 MDS) received 5F9+AZA. In total, median age was 73, 62% of AML pts were intermediate or poor cytogenetic risk (38% unknown), all MDS pts were intermediate or high risk by IPSS-R. 5F9 alone or with AZA was well-tolerated with no MTD reached. 5F9 did not potentiate AZA toxicities. Treatment-related AEs ( > 10% of pts) for 5F9+AZA were anemia (25%), thrombocytopenia (20%), and infusion reactions (15%). In 25 efficacy evaluable pts, 8/15 (53%) untreated AML/MDS pts had a CR/CRi to 5F9+AZA (5/10 (50%) in AML, 3/5 (60%) in MDS). 1/10 (10%) r/r AML/MDS pts had a response (MLFS) to 5F9 alone. LSC frequency was reduced/eliminated in most 5F9+aza responders; 50% of responders were MRD negative by flow cytometry. 4/10 (40%) AML pts became RBC transfusion independent and 4/5 (80%) MDS pts had hematologic improvement. Time to response was more rapid (median 1.9 mos) than expected for AZA alone. As of Jan 2019, no responder has relapsed (median follow-up of 3.4 mos (range 1.1 – 6.8 mos). 2 pts had successful allogeneic transplant. Conclusions: 5F9+AZA is a novel immunotherapy blocking a key macrophage checkpoint. It has been well tolerated with robust activity in AML/MDS pts with rapid CRs and MRD negativity. Adding 5F9 to cytotoxic agents may be a promising treatment strategy. An expansion cohort is ongoing. Funded by Forty Seven and the California Institute for Regenerative Medicine. Clinical trial information: NCT03248479

 
Other Abstracts in this Sub-Category:

 

1. Effect of gilteritinib on survival in patients with FLT3-mutated (FLT3mut+) relapsed/refractory (R/R) AML who have common AML co-mutations or a high FLT3-ITD allelic ratio.

Meeting: 2019 ASCO Annual Meeting Abstract No: 7000 First Author: Mark J. Levis
Category: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant - Acute Leukemia

 

2. A randomized phase II trial of CX-01 with standard therapy in elderly patients with acute myeloid leukemia (AML).

Meeting: 2019 ASCO Annual Meeting Abstract No: 7001 First Author: Tibor Kovacsovics
Category: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant - Acute Leukemia

 

3. Association of smoking with poor risk ELN 2017, cytogenetics/molecular profile, and survival outcomes in acute myeloid leukemia.

Meeting: 2019 ASCO Annual Meeting Abstract No: 7002 First Author: Mansour Alfayez
Category: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant - Acute Leukemia

 

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