Incyte Corporation — Zynyz EMA EPAR variation assessment report (EMEA/H/C/006194, 2024)
Incyte Corporation · 2024 · EMA EPAR variation assessment report · company profile →
Report summary
Incyte Biosciences Distribution B.V. submitted a Type II variation for Zynyz (retifanlimab) to the EMA, seeking to extend its indication for first-line treatment of metastatic or inoperable locally recurrent squamous cell carcinoma of the anal canal (SCAC) in combination with carboplatin and paclitaxel. The application is based on interim results from the Phase 3 POD1UM-303 study. This study demonstrated a statistically significant improvement in progression-free survival (PFS) with retifanlimab plus chemotherapy, along with improved objective response rates and duration of response. While overall survival (OS) showed a clinically relevant difference, it did not meet statistical significance in the primary analysis due to high crossover rates. The safety profile revealed an increase in immune-related adverse events and treatment discontinuations in the retifanlimab arm, though these were considered manageable. Pharmacokinetic and immunogenicity analyses were also conducted.
Key findings — cited to the page
| Skin reactions (Grade >= 3) in Study INCMGA 0012-202 (Retifanlimab Monotherapy) | 2.1 % | INCMGA 0012-202 · p.79 |
| Hypothyroidism (all grades) in Study INCMGA 0012-202 (Retifanlimab Monotherapy) | 9.6 % | INCMGA 0012-202 · p.79 |
| Adrenal insufficiency (Grade 3 or higher) in retifanlimab + chemotherapy group | 1.9 % | · p.75 |
| Skin reactions (Grade 3 or higher) in placebo + chemotherapy group | 0.7 % | · p.75 |
| Grade 3 irAEs in Study INCMGA 0012-202 (Retifanlimab Monotherapy) | 4.3 % | INCMGA 0012-202 · p.78 |
| Grade 5 irAEs in Study INCMGA 0012-202 (Retifanlimab Monotherapy) | 1.1 % | INCMGA 0012-202 · p.78 |
| Colitis (Grade 3 or higher) in retifanlimab + chemotherapy group | 3.2 % | · p.75 |
| Colitis (Grade 3 or higher) in placebo + chemotherapy group | 2.0 % | · p.75 |
| Adrenal insufficiency (Grade 3 or higher) in placebo + chemotherapy group | 0.0 % | · p.75 |
| Skin reactions (Grade 3 or higher) in retifanlimab + chemotherapy group | 1.9 % | · p.75 |
| Grade 4 irAEs in Study INCMGA 0012-202 (Retifanlimab Monotherapy) | 3.2 % | INCMGA 0012-202 · p.78 |
| Hyperthyroidism (all grades) in Study INCMGA 0012-202 (Retifanlimab Monotherapy) | 4.3 % | INCMGA 0012-202 · p.79 |
Source: Incyte Corporation ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →