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).

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.

Informations de copyright

Copyright © 2022 The Authors. Published by Elsevier Ltd.. All rights reserved.

Déclaration de conflit d'intérêts

Disclosure 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. Data sharing 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