Incyte Corporation / MacroGenics, Inc.

Squamous Cell Carcinoma of the Anal Canal (SCAC) and other solid tumors

11K US cases/yr · $26.0B US PD-(L)1 inhibitor market 2023 (parent class) · $29.4B / $9.3B Keytruda / Opdivo global sales 2024 (class context)

Disease Overview

Anti-PD-1 monoclonal antibodies block the PD-1/PD-L1 immune checkpoint, restoring T-cell anti-tumor activity across more than 20 cancer types. SCAC, the lead registrational indication for retifanlimab, is a rare HPV-driven cancer with rising incidence (~2.2%/year) and historically limited options after first-line platinum chemotherapy.

Competitive Landscape

The PD-1 class is dominated by Merck's Keytruda ($29.4B 2024 global sales) and BMS's Opdivo ($9.3B), with Roche's Tecentriq, Regeneron's Libtayo, GSK's Jemperli, and AstraZeneca's Imfinzi/Bavencio rounding out the marketed field — a saturated competitive environment by the time of the 2017 deal (Endpoints News: https://endpts.com/incyte-grabs-a-new-pd-1-checkpoint-drug-in-900m-deal-with-macrogenics/). Incyte's strategy with retifanlimab was explicitly to target niche tumors where PD-1 leaders had not established dominance, then expand via combination with Incyte's IDO and JAK assets. After a high-profile 2021 CRL in anal cancer following a negative AdCom, retifanlimab eventually won FDA approval as Zynyz (retifanlimab-dlwr): first in March 2023 as monotherapy for second-line metastatic Merkel cell carcinoma, then in May 2025 as the first frontline regimen (with platinum chemo) for advanced SCAC based on the POD1UM-303 Phase 3 trial. MacroGenics has earned $100M+ in milestones to date and retains tiered 15-24% royalties — modest absolute commercial scale relative to first-wave PD-1s but commercially viable in defined niches.