RETIFANLIMAB-DLWR INJ,SOLN
Clinical Criteria Summary
Document 696
Exclusion Criteria
- Autoimmune disease
- Immunosuppression including corticosteroid equivalent to >10mg per day of prednisone
- Primary immunodeficiency
- History of allogeneic hematopoietic stem cell transplant or solid organ transplant
- Pregnancy
- Lactating
Inclusion Criteria
- Indication is FDA approved
- Off-label use supported by high-level published data
Additional Inclusion Criteria
- Care is provided by a VA/VA Community Care oncology provider
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Goals of care and role of Palliative Care consult have been discussed and documented
Additional Inclusion Criteria (Select if applicable)
- For patients who can become pregnant and patients with partners who can become pregnant: Counseling provided on potential risks vs benefits of treatment and the use of effective contraception during therapy and for 4 months after stopping treatment
Document 701
Indication & Approved Use
- Metastatic or recurrent locally advanced Merkel cell carcinoma (accelerated approval)
- Rare, aggressive, cutaneous malignancy that predominantly affects older adults with light skin
Dosing & Administration
- 500mg infusion over 30 minutes every 4 weeks
- Dosage form: 500g/20mL injection
Patient Population & Eligibility
- Chemotherapy-naïve (or chemotherapy-refractory) advanced/metastatic Merkel cell carcinoma
- ECOG performance status 0-1
Formulary & Clinical Pathway Considerations
- Optimal therapy for advanced disease is not well-defined; single-agent immunotherapy is generally preferred over chemotherapy
- Retifanlimab does not offer an advantage over pembrolizumab or avelumab in MCC
- Pembrolizumab and avelumab have durable responses with longer follow-up data than retifanlimab
NCCN & VA Oncology Clinical Pathway Recommendations
- NCCN: Category 2B for Primary Locally Advanced Disease, Recurrent Disease, or Metastatic Disease
- VA Oncology Clinical Pathway: For metastatic disease and not a candidate for locoregional therapy, recommend Pembrolizumab
Alternative Treatment Options
- Other recommended regimens (cat 2B): Avelumab, Pembrolizumab (Primary Locally Advanced/Recurrent); Pembrolizumab, Avelumab, Nivolumab, Retifanlimab (Disseminated/Metastatic)
- Alternative options: locoregional treatment (if a candidate) or nivolumab+ipilimumab or carboplatin+etoposide if previous PD-1 therapy