MORGES, Switzerland — Incyte today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion recommending approval of Zynyz (retifanlimab) in combination with carboplatin and paclitaxel, a platinum-based chemotherapy, for the first-line treatment of adult patients with metastatic or inoperable locally recurrent squamous cell carcinoma of the anal canal.
If approved by the European Commission, Zynyz in combination with platinum-based chemotherapy would become the first PD-1 immunotherapy regimen available in Europe for patients with advanced squamous cell carcinoma of the anal canal, a rare and difficult-to-treat cancer.
“Today’s positive CHMP opinion is an important step towards addressing the urgent need for new treatment options for patients in Europe with advanced SCAC, a disease which has seen limited innovation for decades,” said Lee Heeson, Executive Vice President and Head of Incyte International. “If approved, Zynyz in combination with platinum-based chemotherapy has the potential to become a new standard-of-care for patients living with this rare and difficult-to-treat cancer.”
The CHMP opinion is based on results from the Phase 3 POD1UM-303/InterAACT2 clinical trial, which evaluated Zynyz in combination with platinum-based chemotherapy in adult patients with metastatic or inoperable locally recurrent squamous cell carcinoma of the anal canal who had not previously received systemic chemotherapy.
Data from the study demonstrated a statistically significant improvement in progression-free survival for patients treated with the Zynyz combination compared with chemotherapy alone. Patients receiving Zynyz plus chemotherapy achieved a median progression-free survival of 9.3 months, compared with 7.4 months for patients in the placebo combination group, representing a 37 percent reduction in the risk of disease progression or death. No new safety signals were identified in the trial. Serious adverse reactions occurred in 47 percent of patients receiving Zynyz in combination with chemotherapy, with the most frequently reported serious adverse reactions including sepsis, pulmonary embolism, diarrhea, and vomiting.
Squamous cell carcinoma of the anal canal is the most common form of anal cancer, accounting for approximately 85 percent of all cases. Globally, the prevalence of the disease is estimated at around one to two cases per 100,000 people, with a higher incidence observed in women than in men.
The CHMP recommendation will now be reviewed by the European Commission, which has the authority to grant marketing approval for centrally authorized medicines across the European Union.
