Drug updated on 4/17/2024

Dosage FormInjection (intravenous; 500 mg/20 mL [25 mg/mL] solution in a single-dose vial)
Drug ClassProgrammed death receptor-1 (PD-1) blocking antibodies
Ongoing and
Completed Studies


  • Indicated for the treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC).

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  • Retifanlimab-dlwr (Zynyz) is indicated for the treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC). A study focused on its application in treating squamous carcinoma of the anal canal (SCAC), suggesting potential applicability across aggressive forms of cancer.
  • The study was a randomized controlled trial. This limited scope restricts broad comparison but provides specific insights into the effectiveness and safety profile of retifanlimab within a particular patient population.
  • In terms of effectiveness, retifanlimab showed an Overall Response Rate (ORR) of 13.8% and stable disease noted in 35.1% of patients, leading to a Disease Control Rate (DCR) at 48.9%. These results demonstrate its capacity to induce tumor responses or stabilize disease irrespective of clinical factors like HIV/HPV status, PD-L1 expression, or the presence of liver metastases.
  • Safety-wise, retifanlimab's profile is consistent with previous experiences from the PD-(L)1 inhibitor class, indicating acceptable tolerability without unexpected adverse events. This places it alongside other agents within this drug class that are generally well-tolerated compared to chemotherapeutic agents.
  • Duration of response metrics indicate a median duration of response at 9.5 months, while Progression-Free Survival (PFS) and Overall Survival (OS) medians were reported as being at 2.3 and 10.1 months, respectively. These figures suggest durable responses over time among some patients treated with this drug.
  • Despite no direct comparisons made between Zynyz and other drugs, due to limitations posed by having just one study available for review, it appears consistent with similar agents used in different types of tumors based on efficacy and safety profiles. This suggests a possible preference over traditional chemotherapy options, especially when dealing with advanced-stage/refractory cancers.

Product Monograph / Prescribing Information

Document TitleYearSource
Zynyz (retifanlimab-dlwr) Prescribing Information. 2023Incyte Corporation, Wilmington, DE

Randomized Controlled Trials