Incyte"s retifanlimab shows survival benefits for SCAC at ESMO 2024

The Phase 3 POD1UM-303/InterAACT2 trial has shown promising results for retifanlimab in patients with squamous cell anal carcinoma (SCAC), meeting its primary endpoint of progression-free survival. The trial demonstrated a statistically significant improvement in overall response rate and duration of response when retifanlimab was combined with platinum-based chemotherapy compared to a placebo. These findings were presented at the European Society for Medical Oncology (ESMO) Congress 2024, highlighting the potential of this treatment in a patient population with limited options. The incidence of SCAC is rising, largely due to human papillomavirus (HPV) and exacerbated by human immunodeficiency virus (HIV), which significantly increases the risk of developing this cancer. Currently, there are no FDA-approved treatments for advanced SCAC, making the results of this trial particularly significant. The positive data from the trial supports Incyte's plans to file a supplemental Biologics License Application (sBLA) for retifanlimab by the end of 2024. Incyte's President and Head of Research and Development, Dr. Pablo J. Cagnoni, emphasized the importance of these results, noting that this is the first large-scale Phase 3 trial evaluating a checkpoint inhibitor for SCAC. The trial's findings could lead to a new standard-of-care treatment for patients suffering from this aggressive cancer. The company is also planning an in-person event to discuss the trial results further, indicating a commitment to engaging with the scientific community and stakeholders regarding the implications of these findings for future treatment options in SCAC.