Barcelona, Spain – In a Phase 3 clinical trial, Incyte's retifanlimab, a PD-1 targeting antibody, in combination with chemotherapy, demonstrated a significant reduction in disease progression among patients with recurrent or metastatic squamous cell carcinoma of the anal canal. The study's findings, presented at a major oncology conference, suggest that the combination therapy could become a new standard of care for this challenging cancer, which is often linked to human papillomavirus (HPV).
The trial compared retifanlimab plus chemotherapy to chemotherapy alone in patients with advanced anal cancer. The results indicated that adding retifanlimab to chemotherapy decreased the risk of disease progression or death by more than a third. Specifically, the median progression-free survival was 9.3 months in the retifanlimab arm, compared to 7.4 months in the chemotherapy-only arm.
While overall survival data are still maturing, preliminary results suggest a trend towards improved survival in the combination therapy group. Researchers noted that longer-term follow-up is necessary to confirm this benefit definitively. Retifanlimab is already approved as Zynyz for Merkel cell carcinoma.
The study's findings offer hope for patients with advanced anal cancer, a disease with limited treatment options. The current standard of care typically involves chemotherapy, but outcomes remain poor for patients with recurrent or metastatic disease. The introduction of immunotherapy, such as retifanlimab, represents a significant step forward in improving patient outcomes.
The trial's success could pave the way for regulatory approval of retifanlimab in this indication, providing a new treatment option for patients with advanced anal cancer. Further studies are planned to explore the potential of retifanlimab in combination with other therapies and in earlier stages of the disease.