Drug updated on 4/17/2024
| Dosage Form | Injection (intravenous; 500 mg/20 mL [25 mg/mL] solution in a single-dose vial) |
| Drug Class | Programmed death receptor-1 (PD-1) blocking antibodies |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC).
Summary
- 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 Title | Year | Source |
|---|---|---|
| Zynyz (retifanlimab-dlwr) Prescribing Information. | 2023 | Incyte Corporation, Wilmington, DE |
Randomized Controlled Trials
| Document Title | Sex Distribution | Year | Source |
|---|---|---|---|
| A phase II study of retifanlimab (INCMGA00012) in patients with squamous carcinoma of the anal canal who have progressed following platinum-based chemotherapy (POD1UM-202). | 94Subjects F: 65% M: 35% | 2022 | European Society for Medical Oncology Open |
Sex Distribution:
F:65%
M:35%
94Subjects
Year:
2022
Source:European Society for Medical Oncology Open