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ePoster Display

1030TiP - An open-label multicenter phase Ib study of AN0025, a selective inhibitor of the prostaglandin E2 receptor-type-4 receptor, in combination with pembrolizumab in patients with advanced solid tumors

Date

16 Sep 2021

Session

ePoster Display

Topics

Clinical Research;  Cytotoxic Therapy

Tumour Site

Presenters

Wallace Akerley

Citation

Annals of Oncology (2021) 32 (suppl_5): S829-S866. 10.1016/annonc/annonc705

Authors

W. Akerley1, M. Reilley2, A. Marabelle3, C. Baldini4, P.A. Cassier5, M. Chisamore6, T. Tang7, N. Lautermilch8, D. Hong9

Author affiliations

  • 1 Internal Medicine, Huntsman Cancer Institute, 84112 - Salt Lake City/US
  • 2 Department Of Medicine, University of Virginia, 22903 - Charlottesville/US
  • 3 Cancer Immunotherapy Program, Gustave Roussy Cancer Campus, Villejuif/FR
  • 4 Drug Development Department (ditep), Gustave Roussy Cancer Center, 94800 - villejuif/FR
  • 5 Department Of Medical Oncology, Centre Léon Bérard, Lyon/FR
  • 6 Oncology Early Clinical Development, Merck & Co., Inc., 07033 - Kenilworth/US
  • 7 Head Of Development Operation, Adlai Nortye, 08902 - North Brunswick/US
  • 8 Clinical Development Dept, AdlaiNortye USA Inc., 08902 - North Brunswick/US
  • 9 Division Of Cancer Medicine, MD Anderson, Houston/US

Resources

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Abstract 1030TiP

Background

AN0025 is a selective inhibitor of the prostaglandin E2 type-4 receptor, inhibiting PGE2-mediated differentiation and suppressive function of monocytic myeloid cells, which contribute to the immunosuppressive tumor microenvironment. These cells are associated with a poorer prognosis in many cancers. A previous Ph 1 study with AN0025 was conducted to assess safety, MTD and RP2D. AN0025 was well tolerated in 30 patients with advanced cancer at 125, 250, 500, 750 mg QD with no DLTs. The MTD was not reached. 23% of patients achieved stable disease, 5 were clinically stable for ≥ 18 weeks. 10 patients received AN0025 treatment longer than their most recent prior therapy, including 2 immunotherapy patients (Hong DS, et al. J Immunother Cancer 2020).

Trial design

AN0025 and Pembrolizumab have unique mechanisms of action and safety profiles. Combination therapy may safely provide synergistic antitumor outcomes and improve retreatment with pembrolizumab. AN0025S0103 is an open-label, multicenter, phase I study to evaluate safety of AN0025 with pembrolizumab in patients with locally advanced/metastatic tumors, including Bladder, NSCLC, TNBC, Cervical, and MSS CRC. Patients have received no more than 3 prior lines of systemic therapy and have either 1) progressed on treatment with an anti-PD-1/PD-L1 and failed or are deemed inappropriate for additional standard treatments, or 2) have not received prior anti-PD-1/PD-L1 therapy and failed SOC treatment. Study includes a DLT observation phase (Ia), followed by an expansion phase (Ib), to assess AEs and safety. Pembrolizumab given 200 mg Q3W for each dose level of AN0025 (500, 250, and 125 mg QD), for a maximum of 35 cycles. In phase 1a, 12-24 patients will be enrolled, sample size determined by DLTs. In Expansion Cohorts, 10-12 patients will be enrolled in each tumor type. With 12 patients per cohort, the probability of observing ≥1 responder is 72% when the true underlying response rate in the cohort is as low as 10%. Secondary Endpoints include ORR, DOR, PFS OS overall and by PD-L1 expression. The trial opened 2020 and 15 patients have enrolled.

Clinical trial identification

NCT04432857.

Editorial acknowledgement

Legal entity responsible for the study

Adlai Nortye USA INC.

Funding

Adlai Nortye USA INC.

Disclosure

A. Marabelle: Financial Interests, Institutional, Principal Investigator: Roche/Genentech; Financial Interests, Institutional, Principal Investigator: BMS; Financial Interests, Institutional, Principal Investigator: Merck; Financial Interests, Institutional, Principal Investigator: Pfizer; Financial Interests, Institutional, Principal Investigator: Lytix pharma; Financial Interests, Institutional, Principal Investigator: Eisai; Financial Interests, Institutional, Principal Investigator: AstraZeneca/Medimmune; Financial Interests, Institutional, Principal Investigator: Tesaro; Financial Interests, Institutional, Principal Investigator: Chugai; Financial Interests, Institutional, Principal Investigator: OSE immunotherapeutics; Financial Interests, Institutional, Principal Investigator: SOTIO; Financial Interests, Institutional, Principal Investigator: Molecular Partners; Financial Interests, Institutional, Principal Investigator: IMCheck; Financial Interests, Institutional, Principal Investigator: Pierre Fabre; Financial Interests, Institutional, Principal Investigator: Adlai Nortye; Financial Interests, Institutional, Advisory Role: Oncovir; Financial Interests, Institutional, Advisory Role: Centre Léon Bérard; Financial Interests, Personal, Advisory Role: Merck Serono; Financial Interests, Personal, Advisory Role: eTheRNA; Financial Interests, Personal, Advisory Role: Lytix pharma; Financial Interests, Personal, Advisory Role: Kyowa Kirin Pharma; Financial Interests, Personal, Advisory Role: Novartis; Financial Interests, Personal, Advisory Role: BMS; Financial Interests, Personal, Advisory Role: Symphogen; Financial Interests, Personal, Advisory Role: Genmab; Financial Interests, Personal, Advisory Role: Amgen; Financial Interests, Personal, Advisory Role: Biothera; Financial Interests, Personal, Advisory Role: Nektar; Financial Interests, Personal, Advisory Role: Tesaro/GSK; Financial Interests, Personal, Advisory Role: Oncosec; Financial Interests, Personal, Advisory Role: Pfizer; Financial Interests, Personal, Advisory Role: Seattle Genetics; Financial Interests, Personal, Advisory Role: AstraZeneca/Medimmune; Financial Interests, Personal, Advisory Role: Servier; Financial Interests, Personal, Advisory Role: Gritstone; Financial Interests, Personal, Advisory Role: Molecular Partners; Financial Interests, Personal, Advisory Role: Bayer; Financial Interests, Personal, Advisory Role: Partner Therapeutics; Financial Interests, Personal, Advisory Role: Sanofi; Financial Interests, Personal, Advisory Role: Pierre Fabre; Financial Interests, Personal, Advisory Role: RedX pharma; Financial Interests, Personal, Advisory Role: OSE Immunotherapeutics; Financial Interests, Personal, Advisory Role: Medicxi; Financial Interests, Personal, Advisory Role: HiFiBio; Financial Interests, Personal, Advisory Role: IMCheck; Financial Interests, Personal, Advisory Role: MSD; Financial Interests, Personal, Advisory Role: iTeos; Financial Interests, Personal, Advisory Role: Innate Pharma; Financial Interests, Personal, Advisory Role: Shattuck Labs; Financial Interests, Personal, Advisory Role: Medincell; Financial Interests, Personal, Advisory Role: Tessa Therapeutics; Financial Interests, Personal, Advisory Role: Deka Biosciences; Financial Interests, Personal, Invited Speaker: Roche/Genentech; Financial Interests, Personal, Invited Speaker: BMS; Financial Interests, Personal, Invited Speaker: Merck (MSD); Financial Interests, Personal, Invited Speaker: Merck Serono; Financial Interests, Personal, Invited Speaker: AstraZeneca/Medimmune; Financial Interests, Personal, Invited Speaker: Amgen; Financial Interests, Personal, Invited Speaker: Sanofi; Financial Interests, Personal, Invited Speaker: Servier.; Financial Interests, Personal, Advisory Role: Roche; Financial Interests, Personal, Advisory Role: Pierre Fabre; Financial Interests, Personal, Advisory Role: Onxeo; Financial Interests, Personal, Advisory Role: Eisai; Financial Interests, Personal, Advisory Role: Bayer; Financial Interests, Personal, Advisory Role: Genticel; Financial Interests, Personal, Advisory Role: Rigontec; Financial Interests, Personal, Advisory Role: Daichii Sankyo; Financial Interests, Personal, Advisory Role: Imaxio; Financial Interests, Personal, Advisory Role: Sanofi/BioNTech; Financial Interests, Personal, Advisory Role: Molecular Partners; Financial Interests, Personal, Advisory Role: Pillar Partners; Financial Interests, Personal, Advisory Role: BPI; Financial Interests, Personal, Advisory Role: Faron; Financial Interests, Personal, Advisory Role: Applied Materials; Non-Financial Interests, Personal, Other, Travel: AstraZeneca; Non-Financial Interests, Personal, Other, Travel: BMS; Non-Financial Interests, Personal, Other, Travel: Merck (MSD); Non-Financial Interests, Personal, Other, Travel: Roche; Financial Interests, Personal, Stocks/Shares: Pegascy SAS; Financial Interests, Personal, Stocks/Shares: Centessa Pharmaceuticals; Financial Interests, Personal, Stocks/Shares: HiFiBio; Financial Interests, Personal, Stocks/Shares: Shattuck Labs. C. Baldini: Financial Interests, Personal, Invited Speaker: Sanofi; Financial Interests, Personal, Invited Speaker: BMS; Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Institutional, Research Grant: Seattle Genetics; Financial Interests, Institutional, Research Grant: Iteos; Financial Interests, Institutional, Research Grant: Tahio; Financial Interests, Institutional, Principal Investigator: BMS. P.A. Cassier: Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Personal, Invited Speaker: Roche/Genentech; Financial Interests, Personal, Invited Speaker: Amgen; Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Personal, Invited Speaker: Merck Serono; Financial Interests, Institutional, Research Grant: Novartis; Financial Interests, Institutional, Research Grant: Roche/Genentech; Financial Interests, Institutional, Research Grant: Lilly; Financial Interests, Institutional, Research Grant: Blueprint Medicines; Financial Interests, Institutional, Research Grant: Bayer; Financial Interests, Institutional, Research Grant: AstraZeneca; Financial Interests, Institutional, Research Grant: Celgene; Financial Interests, Institutional, Research Grant: Plexxikon; Financial Interests, Institutional, Research Grant: Abbvie; Financial Interests, Institutional, Research Grant: BMS; Financial Interests, Institutional, Research Grant: Merck Serono; Financial Interests, Institutional, Research Grant: Merck Sharp & Dohme; Financial Interests, Institutional, Research Grant: Taiho Pharmaceutical; Financial Interests, Institutional, Research Grant: Toray Industries; Financial Interests, Institutional, Research Grant: Transgene; Financial Interests, Institutional, Research Grant: Loxo; Financial Interests, Institutional, Research Grant: GlaxoSmithKline; Financial Interests, Institutional, Research Grant: Innate Pharma; Financial Interests, Institutional, Research Grant: Janssen; Financial Interests, Personal, Other, Travel: Roche; Financial Interests, Personal, Other, Travel: Amgen; Financial Interests, Personal, Other, Travel: Novartis; Financial Interests, Personal, Other, Travel: Bristol-Myers Squibb; Financial Interests, Personal, Other, Travel: Merck Sharp & Dohme; Financial Interests, Personal, Other, Travel: Netris Pharma; Financial Interests, Personal, Other, Travel: Bayer; Financial Interests, Personal, Other, Travel: Merck Serono. M. Chisamore: Financial Interests, Institutional, Full or part-time Employment: Merck; Financial Interests, Institutional, Stocks/Shares: Merck. T. Tang: Financial Interests, Institutional, Full or part-time Employment: Adlai Nortye; Financial Interests, Institutional, Stocks/Shares: Adlai Nortye. N. Lautermilch: Financial Interests, Institutional, Full or part-time Employment: Adlai Nortye; Financial Interests, Institutional, Stocks/Shares: Adlai Nortye. D. Hong: Financial Interests, Institutional, Research Grant: AbbVie; Financial Interests, Institutional, Research Grant: Adaptimmune; Financial Interests, Institutional, Research Grant: Adlai Nortye; Financial Interests, Institutional, Research Grant: Amgen; Financial Interests, Institutional, Research Grant: Amgen; Financial Interests, Institutional, Research Grant: Bayer; Financial Interests, Institutional, Research Grant: Bristol Myers Squibb; Financial Interests, Institutional, Research Grant: Daiichi Sankyo; Financial Interests, Institutional, Research Grant: Eisai; Financial Interests, Institutional, Research Grant: Eli Lilly; Financial Interests, Institutional, Research Grant: EMD Serono; Financial Interests, Institutional, Research Grant: Erasca; Financial Interests, Institutional, Research Grant: Fate Therapeutics; Financial Interests, Institutional, Research Grant: Genentech; Financial Interests, Institutional, Research Grant: Genmab; Financial Interests, Institutional, Research Grant: GlaxoSmithKline; Financial Interests, Institutional, Research Grant: Ignyta; Financial Interests, Institutional, Research Grant: nfinity; Financial Interests, Institutional, Research Grant: Kite; Financial Interests, Institutional, Research Grant: Kyowa; Financial Interests, Institutional, Research Grant: Loxo; Financial Interests, Institutional, Research Grant: Merck; Financial Interests, Institutional, Research Grant: MedImmune; Financial Interests, Institutional, Research Grant: Millenium; Financial Interests, Institutional, Research Grant: Mirati; Financial Interests, Institutional, Research Grant: miRNA; Financial Interests, Institutional, Research Grant: Molecular Templates; Financial Interests, Institutional, Research Grant: Mologen; Financial Interests, Institutional, Research Grant: Navier; Financial Interests, Institutional, Research Grant: NCI-CTEP; Financial Interests, Institutional, Research Grant: Novartis; Financial Interests, Institutional, Research Grant: Numab; Financial Interests, Personal, Research Grant: Pfizer; Financial Interests, Institutional, Research Grant: Seattle Genetics; Financial Interests, Institutional, Research Grant: Takeda; Financial Interests, Institutional, Research Grant: Turning Point Therapeutics; Financial Interests, Institutional, Research Grant: Verstatem; Financial Interests, Institutional, Research Grant: VM Oncology; Financial Interests, Personal, Other, Travel: AACR; Financial Interests, Personal, Other, Travel: Amgen; Financial Interests, Personal, Other, Travel: ASCO; Financial Interests, Personal, Other, Travel: AstraZeneca; Financial Interests, Personal, Other, Travel: Bayer; Financial Interests, Personal, Other, Travel: Celgene; Financial Interests, Personal, Other, Travel: Eli Lilly; Financial Interests, Personal, Other, Travel: Genentech; Financial Interests, Personal, Other, Travel: Genmab; Financial Interests, Personal, Other, Travel: GlaxoSmithKline; Financial Interests, Personal, Other, Travel: Janssen; Financial Interests, Personal, Other, Travel: LOXO; Financial Interests, Personal, Other, Travel: miRNA; Financial Interests, Personal, Other, Travel: Pfizer; Financial Interests, Personal, Other, Travel: Philips; Financial Interests, Personal, Other, Travel: SITC; Financial Interests, Personal, Invited Speaker: Takeda; Financial Interests, Personal, Invited Speaker: Tavistock; Financial Interests, Personal, Invited Speaker: Trieza; Financial Interests, Personal, Invited Speaker: WebMD; Financial Interests, Personal, Invited Speaker: Alpha Insights; Financial Interests, Personal, Invited Speaker: Acuta; Financial Interests, Personal, Invited Speaker: Amgen; Financial Interests, Personal, Invited Speaker: Axiom; Financial Interests, Personal, Invited Speaker: Adaptimmune; Financial Interests, Personal, Invited Speaker: Baxter; Financial Interests, Personal, Invited Speaker: Bayer; Financial Interests, Personal, Invited Speaker: Boxer Capital; Financial Interests, Personal, Invited Speaker: COG; Financial Interests, Personal, Invited Speaker: Ecor1; Financial Interests, Personal, Invited Speaker: Genentech; Financial Interests, Personal, Invited Speaker: GLG; Financial Interests, Personal, Invited Speaker: Group H; Financial Interests, Personal, Invited Speaker: Guidepoint; Financial Interests, Personal, Invited Speaker: HCW; Financial Interests, Personal, Invited Speaker: Infinity; Financial Interests, Personal, Invited Speaker: Janssen; Financial Interests, Personal, Invited Speaker: Merrimack; Financial Interests, Personal, Invited Speaker: Medscape; Financial Interests, Personal, Invited Speaker: Numab; Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Personal, Invited Speaker: Prime Oncology; Financial Interests, Personal, Invited Speaker: Seattle Genetics; Financial Interests, Personal, Invited Speaker: ST Cube; Financial Interests, Personal, Advisory Board: Molecular Match; Financial Interests, Personal, Ownership Interest: OncoResponse; Financial Interests, Personal, Advisory Board: Presagia Inc. All other authors have declared no conflicts of interest.

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