Retifanlimab
- Generic Name
- Retifanlimab
- Brand Names
- Zynyz
- Drug Type
- Biotech
- CAS Number
- 2079108-44-2
- Unique Ingredient Identifier
- 2Y3T5IF01Z
- Background
Retifanlimab is a humanized IgG4 kappa monoclonal antibody that binds to the programmed death receptor-1 (PD-1), blocking PD-1 interaction with its ligands, programmed death-ligand 1 (PD-L1) and programmed death-ligand 2 (PD-L2). By blocking the PD-1/PD-L1/2 pathway, retifanlimab potentiates T-cell activity and boosts the immune response against cancer cells. Other monoclonal antibodies that block PD-1 include pembrolizumab, nivolumab and cemiplimab.
On October 2021, Incyte Biosciences withdrew its application for a marketing authorization of retifanlimab for the treatment of squamous carcinoma of the anal canal. On March 2023, the FDA granted accelerated approval to retifanlimab for a different indication, the treatment of metastatic or recurrent locally advanced Merkel cell carcinoma (MCC). The use of retifanlimab in combination with other oncology drugs for the treatment of metastatic gastroesophageal adenocarcinoma has also been evaluated.
- Indication
Retifanlimab is indicated for the treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma.
- Associated Conditions
- Metastatic Locally Advanced Merkel Cell Carcinoma, Recurrent, locally advanced Merkel Cell Carcinoma
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Retifanlimab Plus Chemotherapy Shows Promise in Advanced Squamous Cell Anal Carcinoma
• Phase 3 POD1UM-303 trial shows retifanlimab combined with chemotherapy significantly improves progression-free survival in patients with locally recurrent or metastatic squamous cell anal carcinoma (SCAC).
• The combination therapy demonstrated a median PFS of 9.3 months compared to 7.4 months with chemotherapy alone, marking a potential new standard of care.
• Interim overall survival data also suggest a trend towards improvement with the addition of retifanlimab, with manageable immune-related adverse effects.
• The study's success supports a planned supplemental biologics license application (sBLA) for retifanlimab, offering hope for addressing unmet needs in SCAC treatment.
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• Camrelizumab plus chemotherapy significantly improved pathologic complete response (pCR) rates in early or locally advanced triple-negative breast cancer (TNBC).
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Incyte's Retifanlimab Shows Positive Phase 3 Results in Non-Small Cell Lung Cancer
• Incyte's Phase 3 POD1UM-304 trial showed retifanlimab plus chemotherapy significantly improved overall survival in NSCLC patients.
• The combination therapy resulted in a median overall survival of 18.1 months compared to 13.4 months with chemotherapy alone.
• The study also met secondary endpoints, including progression-free survival, overall response rate, and duration of response.
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Zynyz Plus Chemotherapy Shows Promise in Advanced Anal Cancer
• Incyte's Zynyz (retifanlimab) combined with chemotherapy significantly improved progression-free survival in previously untreated patients with advanced anal cancer.
• The Phase III POD1UM-303 trial is the first and largest study evaluating a first-line checkpoint inhibitor for advanced anal cancer, addressing a high unmet medical need.
• Zynyz plus platinum-based chemotherapy may represent a new standard of care for patients with advanced squamous cell anal cancer, according to study presenter Sheela Rao.
• Incyte plans to seek FDA approval for Zynyz in anal cancer based on these findings, potentially offering a new treatment option.
Incyte's Zynyz Shows Promise in Frontline Anal Cancer Treatment
• Incyte's Zynyz, combined with chemotherapy, significantly reduced the risk of disease progression or death in patients with squamous cell carcinoma of the anal canal (SCAC).
• The POD1UM-303 trial demonstrated a 37% reduction in disease progression or death and extended median progression-free survival to 9.3 months compared to chemotherapy alone.
• Zynyz also showed a trend towards improved overall survival, with a 30% improvement compared to the control group, potentially establishing it as a new standard of care.
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Retifanlimab Plus Chemotherapy Improves PFS in Advanced Anal Cancer
• The POD1UM-303 trial demonstrated that adding retifanlimab to carboplatin and paclitaxel significantly improved progression-free survival (PFS) in patients with recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC).
• Patients receiving retifanlimab plus chemotherapy experienced a median PFS of 9.3 months compared to 7.4 months with placebo plus chemotherapy, showing a statistically significant improvement.
• The combination therapy also led to a higher overall response rate (ORR) and a longer duration of response (DOR) compared to placebo plus chemotherapy in this patient population.
• Interim overall survival (OS) data suggest a trend towards improved survival with retifanlimab, indicating a potential new standard of care for advanced SCAC.
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