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A Phase 2 Study of INCMGA00012 in Participants With Squamous Carcinoma of the Anal Canal Who Have Progressed Following Platinum-Based Chemotherapy (POD1UM-202)

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Trial Profile

A Phase 2 Study of INCMGA00012 in Participants With Squamous Carcinoma of the Anal Canal Who Have Progressed Following Platinum-Based Chemotherapy (POD1UM-202)

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 21 May 2025

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At a glance

  • Drugs Retifanlimab (Primary)
  • Indications Anal cancer; Squamous cell cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms POD1UM-202
  • Sponsors Incyte Corporation

Most Recent Events

  • 15 May 2025 According to an Incyte media release, company submitted a Type II variation Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for retifanlimab in advanced SCAC and a Japanese New Drug Application (J-NDA) which was accepted by the Pharmaceuticals and Medical Devices Agency (PMDA) for retifanlimab in advanced SCAC.
  • 15 May 2025 According to an Incyte media release, company announced that the U.S. Food and Drug Administration (FDA) has approved Zynyz (retifanlimab-dlwr), in combination with carboplatin and paclitaxel (platinum-based chemotherapy) for the first-line treatment of adult patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC) based on data from two studies Phase 3 POD1UM-303/InterAACT2 and POD1UM-202.
  • 10 Feb 2025 According to an Incyte Corporation media release, the supplemental Biologics License Application (sBLA) submission for retifanlimab (Zynyz) in advanced/metastatic squamous cell anal carcinoma was filed with the FDA with approval anticipated in the second half of 2025.

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