A phase II study of retifanlimab (INCMGA00012) in patients with squamous carcinoma of the anal canal who have progressed following platinum-based chemotherapy (POD1UM-202)

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  • S. Rao, The Royal Marsden
  • ,
  • G. Anandappa, The Royal Marsden
  • ,
  • J. Capdevila, Autonomous University of Barcelona
  • ,
  • L. Dahan, Aix-Marseille Université
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  • L. Evesque, Centre Antoine Lacassagne
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  • S. Kim, Universite de Franche-Comte
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  • M. P. Saunders, Christie Hospital NHS Foundation Trust
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  • D. C. Gilbert, Brighton and Sussex University Hospitals NHS Trust
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  • L. H. Jensen, University Hospital of Southern Denmark
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  • E. Samalin, Universite de Montpellier
  • ,
  • K. L. Spindler
  • S. Tamberi, AUSL Romagna Oncology Unit Faenza Hospital (RA)
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  • A. Demols, Université Libre de Bruxelles
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  • M. G. Guren, University of Oslo
  • ,
  • D. Arnold, Asklepios Klinik St. Georg
  • ,
  • M. Fakih, City of Hope National Med Center
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  • T. Kayyal, Renovatio Clinical
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  • M. Cornfeld, Incyte
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  • C. Tian, Incyte
  • ,
  • M. Catlett, Incyte
  • ,
  • M. Smith, Incyte
  • ,
  • J. P. Spano, Sorbonne Université

Background: Locally advanced or metastatic squamous carcinoma of the anal canal (SCAC) has poor prognosis following platinum-based chemotherapy. Retifanlimab (INCMGA00012), a humanized monoclonal antibody targeting programmed death protein-1 (PD-1), demonstrated clinical activity across a range of solid tumors in clinical trials. We present results from POD1UM-202 (NCT03597295), an open-label, single-arm, multicenter, phase II study evaluating retifanlimab in patients with previously treated advanced or metastatic SCAC. Patients and methods: Patients ≥18 years of age had measurable disease and had progressed following, or were ineligible for, platinum-based therapy. Retifanlimab 500 mg was administered intravenously every 4 weeks. The primary endpoint was overall response rate (ORR) by independent central review. Secondary endpoints were duration of response (DOR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety. Results: Overall, 94 patients were enrolled. At a median follow-up of 7.1 months (range, 0.9-19.4 months), ORR was 13.8% [95% confidence interval (CI) 7.6% to 22.5%], with one complete response (1.1%) and 12 partial responses (12.8%). Responses were observed regardless of human immunodeficiency virus or human papillomavirus status, programmed death ligand 1 (PD-L1) expression, or liver metastases. Stable disease was observed in 33 patients (35.1%) for a DCR of 48.9% (95% CI 38.5% to 59.5%). Median DOR was 9.5 months (range, 5.6 months-not estimable). Median (95% CI) PFS and OS were 2.3 (1.9-3.6) and 10.1 (7.9-not estimable) months, respectively. Retifanlimab safety in this population was consistent with previous experience for the PD-(L)1 inhibitor class. Conclusions: Retifanlimab demonstrated clinically meaningful and durable antitumor activity, and an acceptable safety profile in patients with previously treated locally advanced or metastatic SCAC who have progressed on or are intolerant to platinum-based chemotherapy.

OriginalsprogEngelsk
Artikelnummer100529
TidsskriftESMO Open
Vol/bind7
Nummer4
ISSN2059-7029
DOI
StatusUdgivet - aug. 2022

Bibliografisk note

Funding Information:
SR reports being an advisor or receiving honoraria from Amgen, Celgene, and Shire; travel grants from Bayer, Celgene, and Incyte Corporation. JC reports scientific consultancy role (speaker and advisory roles) for Advanced Accelerator Applications, Amgen, Bayer, Eisai, Eli Lilly, Exelixis, Hutchison MediPharma, Ipsen, Isotopen Technologien München, Merck Serono, Novartis, Pfizer, and Sanofi; research support/grants from Advanced Accelerator Applications, AstraZeneca, Bayer, Eisai, Novartis, and Pfizer. LD reports honoraria from Amgen, Sanofi, and Servier. LE reports honoraria from Merck and Servier. SK reports research funding from Bioprojet Pharma, Boehringer Ingelheim, Bristol Myers Squibb, Novartis, Pfizer, Roche, and Sanofi; advisor or honoraria from Incyte Corporation, Ipsen, Merck Sharp & Dohme, Sanofi, and Servier. MPS reports being an advisor or receiving honoraria from Amgen, Merck, and Servier. ES reports honoraria from or serves on the advisory board for Amgen, Bristol Myers Squibb, Merck Sharp & Dohme, Pierre Fabre Oncology, Roche, Sandoz, and Servier. KLS reports honoraria from Boston Scientific. AD reports consultant and advisory role for AstraZeneca, Basilea Pharmaceutica, Bayer, and Servier; research funding from Bayer. DA reports consultant or advisory role, and/or presentation honoraria from AstraZeneca, Boston Scientific, Bristol Myers Squibb, Eli Lilly, Merck Sharp & Dohme, Pierre Fabre Oncology, Sanofi, Servier, and Terumo. MF reports consultant or advisory role for Amgen, Array BioPharma, GlaxoSmithKline, Incyte Corporation, Pfizer, Seattle Genetics, and Taiho Pharmaceutical; speakers’ bureau for Guardant Health; research funding (institutional) from Amgen, AstraZeneca, Bristol Myers Squibb, and Novartis. MCo , CT , and MS report employment and stock ownership in Incyte Corporation. MCa reports former employment and stock ownership in Incyte Corporation. JPS reports honoraria from AstraZeneca, Biogaran, Bristol Myers Squibb, Eli Lilly, Gilead Sciences, Leo Pharma, Mylan, Myriad Genetics, Novartis, Pfizer, and Pierre Fabre; consulting or advisory role for Merck Sharp & Dohme and Roche; grant from MSD Avenir. All other authors have declared no conflicts of interest.

Funding Information:
The authors thank the patients, their families, and the site personnel who participated in this study. The authors also thank Marianne Veyri (APHP-Sorbonne) for support of the trial conduct. Statistical support was provided by Xiaohan Xu, Kechen Zhao, and Yubing Yao (Incyte Corporation, Wilmington, DE). Medical writing assistance was provided by Sneha DSilva, MD, CMPP (Envision Pharma Group, Philadelphia, PA), and funded by Incyte Corporation. This work was supported by Incyte Corporation (Wilmington, DE, USA) (no grant number). SR reports being an advisor or receiving honoraria from Amgen, Celgene, and Shire; travel grants from Bayer, Celgene, and Incyte Corporation. JC reports scientific consultancy role (speaker and advisory roles) for Advanced Accelerator Applications, Amgen, Bayer, Eisai, Eli Lilly, Exelixis, Hutchison MediPharma, Ipsen, Isotopen Technologien München, Merck Serono, Novartis, Pfizer, and Sanofi; research support/grants from Advanced Accelerator Applications, AstraZeneca, Bayer, Eisai, Novartis, and Pfizer. LD reports honoraria from Amgen, Sanofi, and Servier. LE reports honoraria from Merck and Servier. SK reports research funding from Bioprojet Pharma, Boehringer Ingelheim, Bristol Myers Squibb, Novartis, Pfizer, Roche, and Sanofi; advisor or honoraria from Incyte Corporation, Ipsen, Merck Sharp & Dohme, Sanofi, and Servier. MPS reports being an advisor or receiving honoraria from Amgen, Merck, and Servier. ES reports honoraria from or serves on the advisory board for Amgen, Bristol Myers Squibb, Merck Sharp & Dohme, Pierre Fabre Oncology, Roche, Sandoz, and Servier. KLS reports honoraria from Boston Scientific. AD reports consultant and advisory role for AstraZeneca, Basilea Pharmaceutica, Bayer, and Servier; research funding from Bayer. DA reports consultant or advisory role, and/or presentation honoraria from AstraZeneca, Boston Scientific, Bristol Myers Squibb, Eli Lilly, Merck Sharp & Dohme, Pierre Fabre Oncology, Sanofi, Servier, and Terumo. MF reports consultant or advisory role for Amgen, Array BioPharma, GlaxoSmithKline, Incyte Corporation, Pfizer, Seattle Genetics, and Taiho Pharmaceutical; speakers’ bureau for Guardant Health; research funding (institutional) from Amgen, AstraZeneca, Bristol Myers Squibb, and Novartis. MCo, CT, and MS report employment and stock ownership in Incyte Corporation. MCa reports former employment and stock ownership in Incyte Corporation. JPS reports honoraria from AstraZeneca, Biogaran, Bristol Myers Squibb, Eli Lilly, Gilead Sciences, Leo Pharma, Mylan, Myriad Genetics, Novartis, Pfizer, and Pierre Fabre; consulting or advisory role for Merck Sharp & Dohme and Roche; grant from MSD Avenir. All other authors have declared no conflicts of interest. Incyte Corporation (Wilmington, DE, USA) is committed to data sharing that advances science and medicine while protecting patient privacy. Qualified external scientific researchers may request anonymized datasets owned by Incyte Corporation for the purpose of conducting legitimate scientific research. Researchers may request anonymized datasets from any interventional study (except phase I studies) for which the product and indication have been approved on or after 1 January 2020 in at least one major market (e.g. US, EU, JPN). Data will be available for request after the primary publication or 2 years after the study has ended. Information on Incyte Corporation's clinical trial data sharing policy and instructions for submitting clinical trial data requests are available at: https://www.incyte.com/Portals/0/Assets/Compliance%20and%20Transparency/clinical-trial-data-sharing.pdf?ver=2020-05-21-132838-960

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