Matches in SemOpenAlex for { <https://semopenalex.org/work/W4284974088> ?p ?o ?g. }
- W4284974088 endingPage "100529" @default.
- W4284974088 startingPage "100529" @default.
- W4284974088 abstract "•Retifanlimab (PD-1 inhibitor) monotherapy demonstrated encouraging results in patients with platinum-refractory SCAC.•Clinically meaningful antitumor activity was reported with ORR of 13.8% and stable disease in 35.1%, for a DCR of 48.9%.•Observed responses in advanced SCAC were durable (median 9.5 months).•Acceptable safety profile consistent with that reported for the PD-(L)1 inhibitor class.•Promising results warrant further investigation of retifanlimab in advanced SCAC as well as earlier stages of disease. BackgroundLocally 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 methodsPatients ≥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.ResultsOverall, 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.ConclusionsRetifanlimab 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. 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 ≥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. 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. 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." @default.
- W4284974088 created "2022-07-10" @default.
- W4284974088 creator A5001479918 @default.
- W4284974088 creator A5005521442 @default.
- W4284974088 creator A5006355590 @default.
- W4284974088 creator A5009032937 @default.
- W4284974088 creator A5011116444 @default.
- W4284974088 creator A5013930160 @default.
- W4284974088 creator A5017741773 @default.
- W4284974088 creator A5028007686 @default.
- W4284974088 creator A5028431629 @default.
- W4284974088 creator A5029697647 @default.
- W4284974088 creator A5029703099 @default.
- W4284974088 creator A5039870429 @default.
- W4284974088 creator A5040081800 @default.
- W4284974088 creator A5040739416 @default.
- W4284974088 creator A5041747752 @default.
- W4284974088 creator A5042306519 @default.
- W4284974088 creator A5043962640 @default.
- W4284974088 creator A5052808201 @default.
- W4284974088 creator A5059107350 @default.
- W4284974088 creator A5061200817 @default.
- W4284974088 creator A5074910871 @default.
- W4284974088 creator A5081767061 @default.
- W4284974088 date "2022-08-01" @default.
- W4284974088 modified "2023-10-17" @default.
- W4284974088 title "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)" @default.
- W4284974088 cites W1587588102 @default.
- W4284974088 cites W1985233123 @default.
- W4284974088 cites W1998345145 @default.
- W4284974088 cites W2050320008 @default.
- W4284974088 cites W2063806298 @default.
- W4284974088 cites W2103648930 @default.
- W4284974088 cites W2104342315 @default.
- W4284974088 cites W2111079175 @default.
- W4284974088 cites W2131979371 @default.
- W4284974088 cites W2133420310 @default.
- W4284974088 cites W2158244375 @default.
- W4284974088 cites W2164644812 @default.
- W4284974088 cites W2304953639 @default.
- W4284974088 cites W2435226206 @default.
- W4284974088 cites W2529484692 @default.
- W4284974088 cites W2543747182 @default.
- W4284974088 cites W2552883321 @default.
- W4284974088 cites W2587287943 @default.
- W4284974088 cites W2589072142 @default.
- W4284974088 cites W2602907503 @default.
- W4284974088 cites W2607272476 @default.
- W4284974088 cites W2734526782 @default.
- W4284974088 cites W2736166064 @default.
- W4284974088 cites W2763963251 @default.
- W4284974088 cites W2773124333 @default.
- W4284974088 cites W2786816161 @default.
- W4284974088 cites W2800129568 @default.
- W4284974088 cites W2802644926 @default.
- W4284974088 cites W2810482013 @default.
- W4284974088 cites W2897815318 @default.
- W4284974088 cites W2903493423 @default.
- W4284974088 cites W2925815206 @default.
- W4284974088 cites W2974183337 @default.
- W4284974088 cites W3015755028 @default.
- W4284974088 cites W3029930204 @default.
- W4284974088 cites W3034884769 @default.
- W4284974088 cites W3083986479 @default.
- W4284974088 cites W3084149108 @default.
- W4284974088 cites W3088833629 @default.
- W4284974088 cites W3113025934 @default.
- W4284974088 cites W3128646645 @default.
- W4284974088 cites W3162733280 @default.
- W4284974088 cites W3164232230 @default.
- W4284974088 cites W3173506613 @default.
- W4284974088 cites W3200231835 @default.
- W4284974088 cites W4210463828 @default.
- W4284974088 doi "https://doi.org/10.1016/j.esmoop.2022.100529" @default.
- W4284974088 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/35816951" @default.
- W4284974088 hasPublicationYear "2022" @default.
- W4284974088 type Work @default.
- W4284974088 citedByCount "18" @default.
- W4284974088 countsByYear W42849740882021 @default.
- W4284974088 countsByYear W42849740882022 @default.
- W4284974088 countsByYear W42849740882023 @default.
- W4284974088 crossrefType "journal-article" @default.
- W4284974088 hasAuthorship W4284974088A5001479918 @default.
- W4284974088 hasAuthorship W4284974088A5005521442 @default.
- W4284974088 hasAuthorship W4284974088A5006355590 @default.
- W4284974088 hasAuthorship W4284974088A5009032937 @default.
- W4284974088 hasAuthorship W4284974088A5011116444 @default.
- W4284974088 hasAuthorship W4284974088A5013930160 @default.
- W4284974088 hasAuthorship W4284974088A5017741773 @default.
- W4284974088 hasAuthorship W4284974088A5028007686 @default.
- W4284974088 hasAuthorship W4284974088A5028431629 @default.
- W4284974088 hasAuthorship W4284974088A5029697647 @default.
- W4284974088 hasAuthorship W4284974088A5029703099 @default.
- W4284974088 hasAuthorship W4284974088A5039870429 @default.
- W4284974088 hasAuthorship W4284974088A5040081800 @default.
- W4284974088 hasAuthorship W4284974088A5040739416 @default.
- W4284974088 hasAuthorship W4284974088A5041747752 @default.
- W4284974088 hasAuthorship W4284974088A5042306519 @default.