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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Authors
Rao, S.Anandappa, G.
Capdevila, J.
Dahan, L.
Evesque, L.
Kim, S.
Saunders, Mark P
Gilbert, D. C.
Jensen, L. H.
Samalin, E.
Spindler, K. L.
Tamberi, S.
Demols, A.
Guren, M. G.
Arnold, D.
Fakih, M.
Kayyal, T.
Cornfeld, M.
Tian, C.
Catlett, M.
Smith, M.
Spano, J. P.
Affiliation
The Royal Marsden, London, UKIssue Date
2022
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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.Citation
Rao S, Anandappa G, Capdevila J, Dahan L, Evesque L, Kim S, et al. 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). ESMO open. 2022 Jul 8;7(4):100529. PubMed PMID: 35816951. Epub 2022/07/12. eng.Journal
ESMO OpenDOI
10.1016/j.esmoop.2022.100529PubMed ID
35816951Additional Links
https://dx.doi.org/10.1016/j.esmoop.2022.100529Type
ArticleLanguage
enae974a485f413a2113503eed53cd6c53
10.1016/j.esmoop.2022.100529
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