Zynyz(retifanlimab)
Oncology· 1967 cited findings· 2 source documents
Company: Incyte Corporation →
What the regulatory reviews say
Zynyz (retifanlimab) is proposed as a monotherapy for the treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC). It received Orphan medicinal product designation for Merkel cell carcinoma on 13 January 2023 and FDA approval in April 2023. A Marketing authorization application was submitted on 27 February 2023, and a CHMP positive opinion was issued on 22 February 2024.
In efficacy studies, Zynyz demonstrated an objective response rate (ORR) of 52.3% and 53.5%. The complete response (CR) rate was 18.5% and 16.8%, while the partial response (PR) rate was 33.8% and 36.6%. The median duration of response (DOR) was 25.26 months, with 72.2% of responses lasting at least 6 months and 63.0% lasting at least 12 months. The disease control rate (DCR) was 59.4%, and the median progression-free survival (PFS) was 12.65 months.
Regarding safety, pneumonitis (all grades) was observed at rates of 4.7%, 2.6%, and 3.1%, with Grade >= 3 pneumonitis occurring at rates of 1.9%, 0.9%, and 1.1%. Colitis (all grades) was reported at rates of 4.7% and 2.0%, with Grade >= 3 colitis at 0.0% and 0.9%.
Key figures — cited to the source page
| Objective response rate (ORR) | 52.3 | Incyte Corporation — Zynyz EMA EPAR public assessment report, p.113 |
| Complete response (CR) rate | 18.5 | Incyte Corporation — Zynyz EMA EPAR public assessment report, p.113 |
| Median duration of response (DOR) | 25.26 | Incyte Corporation — Zynyz EMA EPAR public assessment report, p.114 |
| Pneumonitis (All Grades) rate | 4.7 | Incyte Corporation — Zynyz EMA EPAR public assessment report, p.142 |
| Pneumonitis (Grade >= 3) rate | 1.9 | Incyte Corporation — Zynyz EMA EPAR public assessment report, p.142 |
| Colitis (All Grades) rate | 4.7 | Incyte Corporation — Zynyz EMA EPAR public assessment report, p.142 |
| FDA approval date | April 2023 | Incyte Corporation — Zynyz EMA EPAR public assessment report, p.13 |
| CHMP positive opinion date | 22 February 2024 | Incyte Corporation — Zynyz EMA EPAR public assessment report, p.9 |
Source documents
Explore the full evidence
All 1967 cited findings for Zynyz — searchable, comparable and answerable in plain language — are in the Oncology research library →
Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.