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A phase 1a/1b trial of CSF-1R inhibitor LY3022855 in combination with durvalumab or tremelimumab in patients with advanced solid tumors

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Summary

Background LY3022855 is a recombinant, immunoglobulin, human monoclonal antibody targeting the colony-stimulating factor-1 receptor. This phase 1 trial determined the safety, pharmacokinetics, and antitumor activity of LY3022855 in combination with durvalumab or tremelimumab in patients with advanced solid cancers who had received standard anti-cancer treatments. Methods In Part A (dose-escalation), patients received intravenous (IV) LY3022855 25/50/75/100 mg once weekly (QW) combined with durvalumab 750 mg once every two weeks (Q2W) IV or LY3022855 50 or 100 mg QW IV with tremelimumab 75/225/750 mg once every four weeks. In Part B (dose-expansion), patients with non-small cell lung cancer (NSCLC) or ovarian cancer (OC) received recommended phase 2 dose (RP2D) of LY3022855 from Part A and durvalumab 750 mg Q2W. Results Seventy-two patients were enrolled (median age 61 years): Part A = 33, Part B = 39. In Part A, maximum tolerated dose was not reached, and LY3022855 100 mg QW and durvalumab 750 mg Q2W was the RP2D. Four dose-limiting equivalent toxicities occurred in two patients from OC cohort. In Part A, maximum concentration, area under the concentration-time curve, and serum concentration showed dose-dependent increase over two cycles of therapy. Overall rates of complete response, partial response, and disease control were 1.4%, 2.8%, and 33.3%. Treatment-emergent anti-drug antibodies were observed in 21.2% of patients. Conclusions LY3022855 combined with durvalumab or tremelimumab in patients with advanced NSCLC or OC had limited clinical activity, was well tolerated. The RP2D was LY3022855 100 mg QW with durvalumab 750 mg Q2W. ClinicalTrials.gov ID: NCT02718911 (Registration Date: May 3, 2011).

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Data availability

Eli Lilly and Company provides access to all individual participant data collected during the trial, after anonymization, with the exception of pharmacokinetic or genetic data. Data are available to request six 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 they 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, and blank or annotated case report forms, will be provided in a secure data-sharing environment for up to two years per proposal. For details on submitting a request, see the instructions provided at www.clinicalstudydatarequest.com.

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Acknowledgements

We extend our gratitude to the patients and their families and caregivers for participating in this trial. Medical writing support was provided by Karan Sharma from Eli Lilly Services India Pvt. Ltd.

Funding

This study was funded by Eli Lilly and Company.

Author information

Authors and Affiliations

  1. Drug Development Unit, Sarah Cannon Research Institute at HealthONE, 1800 Williams St Ste 300, Denver, CO, USA

    Gerald S. Falchook

  2. Department of Oncology, University Antwerpen, Universitair Ziekenhuis Antwerpen, Drie Eikenstraat, Edegem, Belgium

    Marc Peeters

  3. Drug Research Unit, Universitair Ziekenhuis Gent, Corneel Heymanslaan, Ghent, Belgium

    Sylvie Rottey

  4. Department of Medical Oncology, GZA Sint Augustinus, Oosterveldlaan, Wilrijk, Belgium

    Luc Y. Dirix

  5. Comprehensive Cancer Care Department – Faculty of Medicine, Masaryk Memorial Cancer Institute, Brno, Czech Republic

    Radka Obermannova

  6. Department of Oncology, Sharett Institute of Oncology, Hadassah Medical Center, Jerusalem, Israel

    Jonathan E. Cohen

  7. The Faculty of Medicine, The Wohl Institute for Translational Medicine, Hadassah Medical Center, Jerusalem, Israel

    Jonathan E. Cohen

  8. Department of Oncology, Clinical Research Institute at Rambam, Rambam Medical Center, Haifa, Israel

    Ruth Perets

  9. Technion – Israel Institute of Technology, Haifa, Israel

    Ruth Perets

  10. The Ella Institute for Immuno-Oncology, Sheba Medical Center, Oncology Institute, Tel Hashomer, Ramat Gan, Israel

    Ronnie Shapira Frommer

  11. Department of Medical Oncology, Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN, USA

    Todd M. Bauer

  12. Hematologic Oncology, Florida Cancer Specialists/Sarah Cannon Research Institute, Sarasota, FL, USA

    Judy S. Wang

  13. Department of Medicine, Division of Hematology/Oncology, Columbia University, College of Physicians and Surgeons, New York, NY, USA

    Richard D. Carvajal

  14. Department of Medicine,Medical Oncology, NYU Langone Health, New York, NY, USA

    Joshua Sabari

  15. Eli Lilly and Company, Windlesham, Surrey, UK

    Sonya Chapman

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

    Wei Zhang, Boris Calderon & Daniel A. Peterson

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  1. Gerald S. Falchook
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  2. Marc Peeters
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  3. Sylvie Rottey
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Contributions

S. Chapman contributed to study conception and design. W. Zhang and S. Chapman contributed to development of methodology. GS. Falchook, JE. Cohen, M. Peeters, RD. Carvajal, TM. Bauer, R. Obermannova, LY. Dirix contributed to acquisition of data. S. Chapman, W. Zhang, DA. Peterson, GS. Falchook, M. Peeters, RD. Carvajal, LY. Dirix, R. Perets, RS. Frommer contributed to analysis and interpretation of data. All authors contributed to writing, review, and/or critical revision of the manuscript.

Corresponding author

Correspondence to Gerald S. Falchook.

Ethics declarations

Ethics approval

The study was performed in accordance with the International Conference on Harmonization guidelines and Declaration of Helsinki 1964 and its amendments. The Institutional Review Board of each study site approved the study protocol, information brochure, and the informed consent form before study initiation.

Consent to participate

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

Consent for publication

Patients provided informed consent to regarding publishing their data.

Conflict of interest

GS. Falchook reports receiving grants from Eli Lilly and Company during the conduct of the study. He also received grants from 3-V Biosciences, Abbisko, ADC Therapeutics, Aileron, American Society of Clinical Oncology, Amgen, ARMO, Beigene, Bioatla, Bioinvent, Biothera, Bicycle, Celldex, Celgene, Ciclomed, Curegenix, Curis, Cyteir, Daiichi, DelMar, eFFECTOR, grants and other from EMD Serono, Epizyme, Exelixis, grants and other from Fujifilm, Genmab, GSK, Hutchison MediPharma, from Igynta, Incyte, Jacobio, Jouce, Kolltan, Loxo, MedImmune, grants and other from Millenium, Merck, miRNA Therapeutics, NIH, Novartis, Oncomed, Oncorus, Oncothyreon, from Poseida, Precision Oncology, Prelude, Regeneron, Rgenix, Ribon, Sapience, Strategia, Syndax, Synthorx, Taiho, Takeda, Tesaro, Tocagen, Turning Point Therapeutics, U.T. MD Anderson Cancer Center, Vegenics, Xencor, other from Wolters-Kluver, other from Sarah Cannon Research Institute, other from Total Health Conferencing, other from Rocky Mountain Oncology Society. He also received Royalties (self): Wolters Kluwer (2014-present) Advisory role (to institution): Fujifilm (2018) Údvisory role (self): EMD Serono (2010, 2011) Travel (self, for work or research related to institution): Bristol-Myers Squibb (2015), EMD Serono (2011, 2012, 2013), Fujifilm (2018), Millennium (2013), Sarah Cannon Research Institute Speakers honorarium for CME: Total Health Conferencing (2019), Rocky Mountain Oncology Society (2020) Research funding (to institution) from Ó-V Biosciences, Abbisko, Abbvie, ADC Therapeutics, Aileron, American Society of Clinical Oncology, Amgen, ARMO, AstraZeneca, BeiGene, Bioatla, Bioinvent, Biothera, Bicycle, Celldex, Celgene, Ciclomed, Curegenix, Curis, Cyteir, Daiichi, DelMar, eFFECTOR, Eli Lilly and Company, EMD Serono, Epizyme, Exelixis, Fujifilm, Genmab, GlaxoSmithKline, Hutchison MediPharma, Ignyta, Incyte, Jacobio, Jounce, Kolltan, Loxo, MedImmune, Millennium, Merck, miRNA Therapeutics, National Institutes of Health, Novartis, OncoMed, Oncorus, Oncothyreon, Poseida, Precision Oncology, Prelude, Regeneron, Rgenix, Ribon, Sapience, Strategia, Syndax, Synthorx, Taiho, Takeda, Tarveda, Tesaro, Tocagen, Turning Point Therapeutics, U.T. MD Anderson Cancer Center, Vegenics, and Xencor.

M. Peeters reports receiving advisory fee from Eli Lilly and Company.

S. Rottey, LY. Dirix, R. Obermannova, and JE. Cohen have no conflicts to disclose.

R. Perets reports receiving personal fees from BiolineRx and Karyopharm Therapeutics.

RD. Carvajal reports receiving personal fees and other from BMS, Incyte, Immunocore, and Merck Roche/Genentech; personal fees from Castle Biosciences, Compugen, Foundation Medicine, I-Mab, PureTech, Sanofi Genzyme, Sorrento Therapeutics, Aura Biosciences, Chimeron, and Rgenix; other from Amgen, Novartis, Pfizer, AstraZeneca, Bellicum, Plexxikon, Mirati, Macrogenics, Corvus, Bayer, Eli Lilly and Company, and Astellis.

J. Sabari reports receiving personal fees from AstraZeneca, Janssen, and Pfizer.

DA. Peterson, S. Chapman, W. Zhang, and B. Calderon are full-time employees of Eli Lilly and Company.

RS. Frommer reports receiving personal fees from MSD, BMS, Roche, Novartis, Clovis oncology, and Astra Zeneca.

TM. Bauer reports receiving grants from Eli Lilly and Company during the conduct of the study; grants 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, and ARMO Biosciences; grants and other from Leap Therapeutics; grants and non-financial support and other from Ignyta and Moderna Therapeutics; grants, personal fees and other from Pfizer; grants, personal fees and non-financial support from Loxo and Bayer; personal fees and non-financial support from Guardant Health; personal fees from Exelesis.

JS. Wang reports receiving research funding to institution from Genentech, Vedanta Biosciences, Relay Therapeutics, Synthorx, Ribon Therapeutics, Clovis Pharma, Xencor, Black Diamond Therapeutics, Vigeo Therapeutics, Qilu Puget Sound Biotherapeutics, Daiichi Sankyo Pharma, Cyteir Therapeutics, Bicycle Therapeutics, Kymab, Prelude Therapeutics, ADC Therapeutics, Revolution Medicines, Klus Pharma, Janssen R&D, Birdie Biopharmaceuticals, Merck, Jacobio Pharmaceuticals, MacroGenics, TopAlliance Biosciences, Moderna, Agenus, Boehringer Ingelheim, Eli Lilly and Company, Tesaro, GlaxoSmithKline, Stemline Therapeutics, BioNTech, Hutchinson MediPharma, Evelo Biosciences, Ignyta, EMD Serono, Novartis Pharmaceuticals, Loxo Oncology, Acerta Pharma, Portola Pharmaceuticals, Celgene Corporation, Taiho Oncology, LSK BioPartners, Olema Pharmaceuticals, and Phoenix Molecular Designs; personal fees and AstraZeneca, H3 Biomedicine, and Syndax.

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Falchook, G.S., Peeters, M., Rottey, S. et al. A phase 1a/1b trial of CSF-1R inhibitor LY3022855 in combination with durvalumab or tremelimumab in patients with advanced solid tumors. Invest New Drugs 39, 1284–1297 (2021). https://doi.org/10.1007/s10637-021-01088-4

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