Press release
Incyte Announces Encouraging Results From Phase 2 Trial of Retifanlimab (INCMGA0012) in Patients With Previously Treated, Advanced Squamous Cell Carcinoma of the Anal Canal
Independent central review confirmed responses include 1 complete response, 12 partial responses and 33 stable disease for an objective response rate of 14%
About this update from Incyte Corporation
[{"type":"text","content":"\n\nIndependent central review confirmed responses include 1 complete response, 12 partial responses and 33 stable disease for an objective response rate of 14% and disease control rate of 49% \n\n\nResponses were observed regardless of PD-L1 status, presence of liver metastases or HIV+ status \n\n\nPresentation is available on-demand as part of the ESMO Virtual Congress 2020 \n\n\nPOD1UM-303/InterAACT 2, a Phase 3 trial evaluating retifanlimab plus chemotherapy in patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal is now open and recruiting patients.\n\n\n WILMINGTON, Del.--(BUSINESS WIRE)--\nIncyte (Nasdaq:INCY) today announced results from its Phase 2 POD1UM-202 trial evaluating retifanlimab, a PD-1 inhibitor, in previously treated patients with advanced squamous cell carcinoma of the anal canal (SCAC) who have progressed following standard platinum-based chemotherapy. The trial enrolled 94 patients, including those with well-controlled human immunodeficiency virus (HIV) infection (10%).\n\nRetifanlimab monotherapy resulted in a confirmed objective response rate (ORR) of 14% as determined by independent central review (ICR) using RECIST v1.1. Responses were observed regardless of PD-L1 status, presence of liver metastases, age or HIV+ status. Retifanlimab was generally well-tolerated with a safety profile as expected of a PD-1 inhibitor and no loss of HIV infection control.\n\nKey findings from POD1UM-202: \n\n\n\n \n\n\n\nN=94\n\n\n\n\n\nORR* (95% CI)\n\n\n\n13.8% (7.6-22.5)\n\n\n\n\n\nBest OR*, n\n\n\n\n1 CR\n\n\n12 PR\n\n\n33 SD\n\n\n\n\n\nDCR\n\n\n\n48.9%\n\n\n\n\n\nDOR, median (95% CI), months\n\n\n\n9.5 (5.6-NE)\n\n\n\n\n\nPFS, median (95% CI), months\n\n\n\n2.3 (1.9-3.6)\n\n\n\n\n\nOS, median (95% CI), months\n\n\n\n10.1 (7.9-NE)\n\n\n\n\n\n*Confirmed responses as determined by independent central review (ICR) using RECIST v1.1.\n\n\nORR: objective response rate; CI: confidence interval; OR: objective response; CR: complete response; PR: partial response; SD: stable disease; DCR: disease control rate; DOR: duration of response; PFS: progression-free survival; OS: overall survival; NE: not estimable.\n\n\n\n\n“The results from the POD1UM-202 trial highlight the potential of retifanlimab to provide a meaningful treatment for patients with SCAC who have progressed following ...