WILMINGTON, DE — A new treatment option has emerged for patients battling advanced squamous cell carcinoma of the anal canal (SCAC). The U.S. Food and Drug Administration (FDA) has approved Zynyz® (retifanlimab-dlwr), a PD-1 targeting monoclonal antibody, for use in combination with carboplatin and paclitaxel (platinum-based chemotherapy) as well as a monotherapy. The announcement marks a breakthrough for patients with limited treatment options for this challenging disease.
Key Approvals
- Combination Therapy: Zynyz is now authorized for first-line treatment of adult patients with inoperable, locally recurrent, or metastatic SCAC in combination with chemotherapy.
- Monotherapy: Approved for patients with locally recurrent or metastatic SCAC who have shown disease progression or intolerance to platinum-based chemotherapy.
“This approval delivers vital progress for a patient group that has faced limited advancements for decades,” said Hervé Hoppenot, Chief Executive Officer of Incyte. “Our teams are proud to bring this innovation to individuals fighting advanced anal cancer, ensuring they have access to effective treatment options.”
Promising Clinical Results
The FDA’s decision was based on compelling data from two pivotal trials evaluating the efficacy and safety of Zynyz.
- Phase 3 POD1UM-303/InterAACT2 Trial:
- Patients treated with the Zynyz-chemotherapy combination experienced a 37% reduction in the risk of progression or death compared to chemotherapy alone, demonstrating a statistically significant improvement in progression-free survival (PFS).
- Median PFS extended to 9.3 months using the combination versus 7.4 months for the control group.
- Median overall survival (OS) improved by 6.2 months, with follow-up ongoing.
- Phase 2 POD1UM-202 Trial:
- Zynyz monotherapy achieved an objective response rate (ORR) of 14% and a disease control rate of 49%.
Commenting on the impact of these trials, Marwan Fakih, M.D., from the City of Hope cancer center, noted, “The addition of Zynyz to platinum-based chemotherapy significantly improves progression-free survival. This approval provides a meaningful new option for patients with a historically grim prognosis.”
Advancing Patient Care
Patients with SCAC have faced high mortality rates and limited therapeutic advancements. The approval of Zynyz, as highlighted by the trials and its demonstrated efficacy, represents a turning point. Serious adverse reactions were consistent with expected profiles of PD-1 inhibitors and included sepsis, pulmonary embolism, and diarrhea in combination therapy.
David Winterflood, CEO of the Anal Cancer Foundation, emphasized the importance of this development, stating, “This approval not only offers a promising treatment pathway but also sheds light on the broader challenges faced by individuals with anal cancer.”
Global Reach
Beyond the U.S., Zynyz is making strides internationally with regulatory submissions to the European Medicines Agency (EMA) and the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan to extend its impact globally.
Zynyz’s approval highlights the importance of continued research and innovation in addressing unmet needs for patients, offering new possibilities for those living with advanced SCAC.
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