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Immunologic and tumor responses of pegilodecakin with 5-FU/LV and oxaliplatin (FOLFOX) in pancreatic ductal adenocarcinoma (PDAC)

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Summary

Background Treatment options for pancreatic ductal adenocarcinoma (PDAC) are limited and checkpoint blockade inhibitors have been disappointing in this disease. Pegilodecakin has demonstrated single agent anti-tumor activity in immune-sensitive tumors. Phase 1 and preclinical data indicate synergy of pegilodecakin with 5-FU and platins. We assessed the safety and activity of pegilodecakin+FOLFOX in patients with PDAC. Methods IVY (NCT02009449) was an open-label phase 1b trial in the United States. Here we report on all enrolled patients from cohort C. Heavily pretreated patients were treated with pegilodecakin (self-administered subcutaneously daily at 2.5, 5, or 10 μg/kg) + 5-flurouracil/leucovorin/oxaliplatin (FOLFOX), dosed per manufacturers prescribing information, until tumor progression. Eligible patients had measurable disease per immune-related response criteria (irRC), were ≥ 18 years of age, and had ECOG performance status of 0 or 1. Patients were evaluated for primary(safety) and secondary (tumor response per irRC) endpoints. Results From 5 August 2014–12 July 2016, 39 patients enrolled in cohort C. All patients were evaluable for safety. In this advanced population, regimen had manageable toxicities with no immune-related adverse events (irAEs) greater than grade 1. The most common grade 3/4/5 TEAEs were thrombocytopenia (21[53.8%] of 39) and anemia (17[43.6%] of 39). In evaluable PDAC patients, the best overall response of pegilodecakin+FOLFOX was 3(14%) with CRs in 2(9%) patients. Conclusions Pegilodecakin+FOLFOX had an acceptable tolerability profile in PDAC, with no substantial irAEs seen, and promising efficacy with the combination yielding a 2-year OS of 24% (95% CI 10–42). These data led to the phase 3 study with pegilodecakin+FOLFOX as second-line therapy of PDAC (SEQUOIA).

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Data availability

Lilly provides access to all individual participant data collected during the trial, after anonymization, with the exception of pharmacokinetic or genetic data. Data are available for request 6 months after the indication studied has been approved in the US and EU and after primary publication acceptance, whichever is later. No expiration date of data requests is currently set once data are made available. Access is provided after a proposal has been approved by an independent review committee identified for this purpose and after receipt of a signed data sharing agreement. Data and documents, including the study protocol, statistical analysis plan, clinical study report, blank or annotated case report forms, will be provided in a secure data sharing environment. For details on submitting a request, see the instructions provided at www.vivli.org.

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Acknowledgements

Kristi Gruver, employee of Eli Lilly and Company, provided medical writing assistance. Editorial assistance was provided by Antonia Baldo. All writing and editorial assistance was funded by Eli Lilly and Company. We thank all the patients who contributed to this study and to all the staff who worked on this project. This study was a collaboration between researchers from different institutions: MD Anderson Cancer Center, Sarah Cannon Research Institute, University of California Los Angeles (UCLA), START Center for Cancer Care, Memorial Sloan Kettering Cancer Center, University of Oklahoma, and ARMO BioSciences, a wholly owned subsidiary of Eli Lilly and Company.

Funding

The work was supported by ARMO BioSciences, a wholly owned subsidiary of Eli Lilly and Company.

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Authors and Affiliations

  1. David Geffen School of Medicine, UCLA, 10833 Le Conte Avenue, Santa Monica, CA, USA

    J. Randolph Hecht, Deborah J. Wong, Zev A. Wainberg & Joseph Leveque

  2. START Center for Cancer Care, 4383 Medical Drive, San Antonio, TX, USA

    Kyriakos P. Papadopoulos

  3. Sarah Cannon Research Institute at HealthONE, 1800 N Williams Street Suite 300, Denver, CO, USA

    Gerald S. Falchook

  4. Sarah Cannon Research Institute/Florida Cancer Specialists, 600 N Cattlemen Road Suite 200, Sarasota, FL, USA

    Manish R. Patel

  5. Sarah Cannon Research Institute/Tennessee Oncology, PLLC, 300 20th Avenue N, Nashville, TN, USA

    Jeffrey R. Infante, Raid Aljumaily, Todd M. Bauer & Johanna Bendell

  6. Stephenson Cancer Center of the University of Oklahoma, 800 NE 10th, Oklahoma City, OK, USA

    Raid Aljumaily & Shubham Pant

  7. Memorial Sloan Kettering Cancer Center, 1275 York Avenue, New York, NY, USA

    Karen A. Autio

  8. MD Anderson Cancer Center, 1515 Holcombe, Houston, TX, USA

    Milind Javle, Shubham Pant & Aung Naing

  9. Eli Lilly and Company, Indianapolis, IN, USA

    Annie Hung & Sujata Rao

  10. ARMO BioSciences, a wholly owned subsidiary of Eli Lilly and Company, 575 Chesapeake Dr., Redwood City, CA, USA

    Navneet Ratti, Peter VanVlasselaer, Rakesh Verma & Martin Oft

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  1. J. Randolph Hecht
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Correspondence to J. Randolph Hecht.

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Conflict of interest

J. Randolph Hecht declares honoraria from ARMO BioSciences a wholly owned subsidiary of Eli Lilly and Company, AstraZeneca, Bristol-Myers Squibb, Gritstone, Halozyme, Ipsen, Merck, Roche; research funding from Abbvie, Advaxis, Amgen, ARMO BioSciences a wholly owned subsidiary of Eli Lilly and Company, Astellas Pharma, Forty Seven, Halozyme, Immunomedics, Eli Lilly and Company, Merck, Novartis; and travel accommodations and expenses from Advaxis, Eli Lilly and Company. Kyriakos P. Papadopoulos declares research funding from Abbvie, Amgen, ArQule, ARMO Biosciences a wholly owned subsidiary of Eli Lilly and Company, ADC Therapeutics, Anheart, 3D Medicines, Basilia, Bayer, Calithera Biosciences, Daiichi Sankyo, EMD Serono, F-star, Incyte, Jounce Therapeutics, Linnaeus, Mabspace Biosciences, Merck, Mirati Therapeutics, MedImmune, Mersana, Peloton Therapeutics, Regeneron, Syros Pharmaceuticals and Tempest Therapeutics; advisory board fees from Arqule, Basilia, Bayer. Gerald S. Falchook declares consulting or advisory role with EMD Serono, Fujifilm; speakers’ bureau with Total Health Conferencing, Rocky Mountain Oncology Society; research funding from 3-V Biosciences, Abbisko, Abbvie, ADC Therapeutics, Aileron Therapeutics, American Society of Clinical Oncology, Amgen, ARMO BioSciences a wholly owned subsidiary of Eli Lilly and Company, AstraZeneca, BeiGene, Bioatla, Bioinvent, Biothera, Bicycle, Celgene, Celldex, Ciclomed, Curegenix, Curis, Cyteir, Daiichi, DelMar Pharmaceuticals, eFFECTOR Therapeutics, Eli Lilly and Company, EMD Serono, Epizyme, Exelixis, Fujifilm, Genmab, GlaxoSmithKline, Hutchison MediPharma, Ignyta, Incyte, Jacobio, Jounce Therapeutics, Koltan Pharmaceuticals, Loxo, MedImmune, Merck, Millenium, miRNA Therapeutics, National Institutes of Health, Novartis, OncoMed, Oncorus, Oncothyreon, Poseida, Precision Oncology, Prelude, Regeneron, Rgenix, Ribon Therapeutics, Sapience, Strategia Therapeutics, Synthorx, Syndax, Taiho Pharmaceutical, Takeda, Tarveda Therapeutics, Tesaro, Tocagen, Turning Point Therapeutics, U.T. MD Anderson Cancer Center, Vegenics, Xencor; patents royalties and other intellectual property with Wolters Kluwer; and travel accommodations and expenses from Bristol-Myers Squibb, EMD Serono, Fujifilm, Millenium, Sarah Cannon Research Institute. Manish R. Patel declares honoraria from Bayer, Genentech, Janssen Oncology, Pfizer, Pharmacyclics; consulting of advisory role with Pfizer/EMD Serono, Pharmacyclics/Janssen; speakers’ bureau with Celgene, Exelixis, Genentech/Roche, Taiho Pharmaceutical; research funding from Acerta Pharma, ADC Therapeutics, Agenus, Aileron Therapeutics, AstraZeneca, Bicycle Therapeutics, BioNTech AG, Boehringer Ingelheim, Calithera Biosciences, Celgene, Checkpoint Therapeutics, CicloMed, Clovis Oncology, Curis, Cyteir Therapeutics, Daiichi Sankyo, eFFECTOR Therapeutics, EMD Serono, Evelo Therapeutics, FORMA Therapeutics, Genentech/Roche, Gilead Sciences, GlaxoSmithKline, H3 Biomedicine, Hengrui Therapeutics, Hutchison MediPharma, Ignyta, Incyte, Jacobio, Janssen, Jounce Therapeutics, Klus Pharma, Kymab, Eli Lilly and Company, Loxo, LSK Biopartners, Lycera, Macrogenics, Merck, Millenium, Mirati Therapeutics, Moderna Therapeutics, Pfizer, Phoenix Molecular Designs, Placon, Portola Pharmaceuticals, Prelude Therapeutics, Puget Sound Biotherapeutics, QiLu Pharmaceuticals, Stemline Therapeutics, Syndax, Synthorx, Taiho Pharmaceutical, Takeda, Tesaro, TopAlliance BioSciences Inc., Vedanta Biosciences, Verastem, Vigeo, Xencor. Jeffrey R. Infante declares employment with Janssen Research & Development with stock and other ownership interests with Johnson & Johnson. Raid Aljumaily declares consulting or advisory role with AstraZeneca, Regeneron; research funding from Abbvie, Alliance Foundation Trials LLC, Array BioPharma, AstraZeneca, Baxalta, Boehringer Ingelheim, Boston Biomedical, Bristol-Myers Squibb, Checkpoint Therapeutics Inc., EMD Serono, F. Hoffman-La Roche AG, G1 Therapeutics, Genentech, GlaxoSmithKline, Huntsman Cancer Institute, Eli Lilly and Company, MedImmune LLC, Merck Co, Novartis, Peloton Therapeutics Inc., Pfizer, Regeneron, Syneos Health, Tesaro. Karen A. Autio declares research funding from Amgen, ARMO BioSciences a wholly owned subsidiary of Eli Lilly and Company, AstraZeneca, CytomX Therapeutics, GlaxoSmithKline, Merck, Pfizer, Tizona Therapeutics Inc. Zev A. Wainberg declares consulting or advisory role with AstraZeneca, Bayer, Eli Lilly and Company, Merck, Novartis; research funding from Novartis, Ipsen, Plexxikon. Todd M. Bauer declares research funding from Daiichi Sankyo, Medpacto, Incyte, Mirati Therapeutics, MedImmune, Abbvie, AstraZeneca, MabVax, Stemline Therapeutics, Merck, Eli Lilly and Company, GlaxoSmithKline, Novartis, Genentech, Deciphera, Merrimack, Immunogen, Millennium, Phosplatin Therapeutics, Calithera Biosciences, Kolltan Pharmaceuticals, Principa Biopharma, Peleton, Immunocore, Roche, Aileron Therapeutics, Bristol-Myers Squibb, Amgen, Onyx, Sanofi, Boehringer-Ingelheim, Astellas Pharma, Five Prime Therapeutics, Jacobio, Top Alliance BioScience, Janssen, Clovis Oncology, Takeda, Karyopharm Therapeutics, Foundation Medicine, ARMO Biosciences a wholly owned subsidiary of Eli Lilly and Company, Leap Therapeutics; grants and non-financial support and consulting services and/or personal fees from Ignyta, Moderna Therapeutics, Pfizer, Loxo, Bayer, Guardant Health; and personal fees from Exelesis. Milind Javle declares consulting or advisory role with Incyte, Mundi, Oncosil, QED; other relationship with Bayer, BeiGene, Incyte, Merck, Merck Serono, Novartis, Pieris Pharmaceuticals, QED Therapeutics, Rafael Pharmaceuticals, Seattle Genetics. Shubham Pant declares honoraria from 4D Pharma; consulting or advisory role with TYME, Xencor, Ipsen; and research funding from ArQule, Bristol-Myers Squibb, Five Prime Therapeutics, GlaxoSmithKline, Ipsen, Eli Lilly and Company, Mirati Therapeutics, Novartis, Onco Response, RedHill BioPharma, Rgenix, Sanofi/Aventis, Xencor. Johanna Bendell declares research funding Gilead, Genentech/Roche, Bristol-Myers Squibb, Five Prime, Eli Lilly and Company, Merck, MedImmune, Celgene, EMD Serono, Taiho, Macrogenics, GSK, Novartis, OncoMed, LEAP, TG Therapeutics, AstraZeneca, BI, Daiichi Sankyo, Bayer, Incyte, Apexigen, Koltan, SynDevRex, Forty Seven, Abbvie, Array, Onyx, Sanofi, Takeda, Eisai, Celldex, Agios, Cytomx, Nektar, ARMO BioSciences a wholly owned subsidiary of Eli Lilly and Company, Boston Biomedical, Ipsen, Merrimack, Tarveda, Tyrogenex, Oncogenex, Marshall Edwards, Pieris, Mersana, Calithera, Blueprint, Evelo, FORMA, Merus, Jacobio, Effector, Novocare, Arrys, Tracon, Sierra, Innate, Arch Oncology, Prelude Therapeutics, Unum Therapeutics, Vyriad, Harpoon, ADC, Amgen, Pfizer, Millenium, Imclone, Acerta Pharma, Rgenix, Bellicum, Gossamer Bio, Arcus Bio, Seattle Genetics, Tempest Tx, Shattuck Labs, Synthorx Inc., Revolution Medicines Inc., Bicycle Therapeutics, Zymeworks, Relay Therapeutics, Atlas Medx, Scholar Rock, NGM Biopharma; consulting services with Gilead, Genentech/Roche, Bristol-Myers Squibb, Five Prime, Eli Lilly and Company, Merck, MedImmune, Celgene, Taiho, Macrogenics, GSK, Novartis, OncoMed, LEAP, TG Therapeutics, AstraZeneca, BI, Daiichi Sankyo, Bayer, Incyte, Apexigen, Ipsen, Merrimack, Oncogenex, Evelo, FORMA, Innate, Arch Oncology, Prelude Therapeutics, Bicycle Therapeutics, Relay Therapeutics, Phoenix Bio, Cyteir, Molecular Partners, Torque, Tizona, Janssen, Tolero, TD2 (Translational Drug Development), Moderna Therapeutics, Tanabe Research Laboratories, Beigene, Continuum Clinical, Amgen, Evelo, Piper Biotech, Samsung Bioepios, ARMO BioSciences a wholly owned subsidiary of Eli Lilly and Company, Agios, Sanofi, Array. Joseph Leveque declares previous employment with stock holdings from ARMO BioSciences a wholly owned subsidiary of Eli Lilly and Company and Synthorx and current employment with stock holdings from Mirati Therapeutics (serving as CMO). Navneet Ratti, Peter VanVlasselaer, Rakesh Verma, and Martin Oft declare former employment with ARMO BioSciences a wholly owned subsidiary of Eli Lilly and Company with stock holdings. Annie Hung and Sujata Rao declare former employment with ARMO BioSciences a wholly owned subsidiary of Eli Lilly and Company and current employment of Eli Lilly and Company with stock holdings. Aung Naing declares consulting or advisory role with CytomX Therapeutics, Novartis, Kymab, Genome; research funding with Amplimmune, ARMO BioSciences a wholly owned subsidiary of Eli Lilly and Company, Atterocor, Bristol-Myers Squibb, Calithera BioSciences, CytomX Therapeutics, EMD Serono, Healios Onc Nutrition, Immune Deficiency Foundation (Spouse), Incyte, Karyopharm Therapeutics, Kymab, Eli Lilly and Company, MedImmune, Merck, NCI, Neon Therapeutics, Novartis, Pfizer, PsiOxus Therapeutics, Regeneron, TopAlliance BioSciences Inc.; travel, accommodations, and expenses from ARMO BioSciences a wholly owned subsidiary of Eli Lilly and Company.

Ethical approval

All procedures performed in the study involving human participants were in accordance with Good Clinical Practice Guidelines (GCP), the US Code of Federal Regulations governing the protection of human patients (21 CFR 50), International Conference on Harmonization (ICH) guidelines, local ethical requirements consistent with the current version of the Declaration of Helsinki, and the Institutional Review Board or Independent Ethics Committees (IEC; 21 CFR 56).

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Informed consent was obtained from all individual participants included in the study.

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Hecht, J.R., Papadopoulos, K.P., Falchook, G.S. et al. Immunologic and tumor responses of pegilodecakin with 5-FU/LV and oxaliplatin (FOLFOX) in pancreatic ductal adenocarcinoma (PDAC). Invest New Drugs 39, 182–192 (2021). https://doi.org/10.1007/s10637-020-01000-6

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