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Poster display session

5206 - Efficacy and Immune Activation with PEGylated human IL-10 (AM0010) in Combination with an anti-PD1 in Advanced NSCLC - Update

Date

09 Sep 2017

Session

Poster display session

Presenters

Deborah Wong

Citation

Annals of Oncology (2017) 28 (suppl_5): v460-v496. 10.1093/annonc/mdx380

Authors

D.J. Wong1, J.G. Schneider2, R. Aljumaily3, M.W. Korn4, K. Autio5, J.R. Infante6, M.R. Patel7, K. Papadopoulos8, A. Naing9, N. Gabrail10, P. Munster11, J. Goldman1, P. Van Vlasselaer12, A. Hung13, G. Brown13, M. Oft13, E.B. Garon14

Author affiliations

  • 1 Department Of Medicine, University of California, Los Angeles, 90024 - Los Angeles/US
  • 2 Oncology, Winthrop University Hospital, Mineola/US
  • 3 Hematology/oncology, Oklahoma University Medical Centre, Oklahoma City/US
  • 4 Cancer Center, UCSF, 94158 - San Francisco/US
  • 5 Genitourinary Oncology, MSKCC, 10065 - New York/US
  • 6 Medical Oncology, Sarah Cannon Research Institute/Tennessee Oncology, 37203 - Nashville/US
  • 7 Oncology, Sarah Cannon Research Institute (Nashville, TN); Florida Cancer Specialists & Research Institute, Sarasota/US
  • 8 Oncology, South Texas Accelerated Research Therapeutics (START), 78229 - San Antonio/US
  • 9 Medical Oncology, MD Anderson Cancer Center, 77030-4095 - Houston/US
  • 10 Oncology, Gabrail Cancer Center, Ohio/US
  • 11 Cancer Center, UCSF Helen Diller Family Comprehensive Cancer Center, 94115 - San Francisco/US
  • 12 Corporate, ARMO BioSciences, 94063 - Redwood City/US
  • 13 Clinical Development, ARMO BioSciences, 94063 - Redwood City/US
  • 14 Oncology/hematology, David Geffen School of Medicine at UCLA, Los Angeles/US
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Resources

Abstract 5206

Background

At therapeutic concentrations, AM0010 stimulates the cytotoxicity, survival and proliferation of intratumoral antigen activated CD8+ T cells in pre-clinical cancer models and in patients. AM0010 activates antigen stimulated CD8 T cells while PD-1 inhibits them, providing a rationale for combining AM0010 with PD-1 inhibitors.

Methods

34 NSCLC pts. received AM0010 (10-20mg/kg QD, SC) with pembrolizumab (2mg/kg, q3wk IV; n = 5) or nivolumab (3mg/kg, q2wk IV; n = 29). Tumor responses were assessed by irRC. Immune responses were measured by analysis of serum cytokines (Luminex), activation of blood derived T cells (FACS) and peripheral T cell clonality (TCR sequencing).

Results

Pts had a median of 2 prior therapies. Median follow-up is 12.9 mo (range 3.7-26.9). AMO010 plus anti-PD-1 was well tolerated. All TrAEs were reversible. G3/4 TrAEs included thrombocytopenia (8), anemia (7), fatigue (6), rash (4), pyrexia (2), hypertriglyceridemia (3) and pneumonitis (1). As of May 5 2017, 26 pts had at least 1 tumor assessment, and partial responses (PRs) were observed in 10 pts (38.5%). 12 patients had stable disease (SD: 46.1%). mPFS and mOS were not reached. Updated efficacy data will be available by Aug. 31 2017.Table:

1316P Preliminary response data stratified for PD-L1 (Study in progress)

NSCLC (n = 26)PD-L1 (22C3 IHC) (n = 20)IHC not available n = 6

Conclusions

AM0010 in combination with anti-PD-1 is well-tolerated in advanced NSCLC pts. AM0010 improved on the expected response rates of nivolumab regardless of PD-L1 status. The observed CD8 T cell activation is promising and encourages the continued study of AM0010 in combination with an anti-PD-1.

Clinical trial identification

NCT02009449

Legal entity responsible for the study

ARMO BioSciences, Redwood City, CA, USA

Funding

ARMO BioSciences, Redwood City, CA, USA

Disclosure

P. Van Vlasselaer: Employment, Stock, board of directors A. Hung: Employment. G. Brown, M. Oft: Employment. All other authors have declared no conflicts of interest.

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