LIFILEUCEL INJ,SUSP
Clinical Criteria Summary
Indication & Patient Population
- Unresectable or metastatic melanoma
- Previously treated with a PD-1 blocking antibody
- If BRAF V600 mutation positive, previously treated with a BRAF inhibitor with or without a MEK inhibitor
VA Clinical Pathway Eligibility (Post-Progression Scenarios)
- Progression after 1L nivolumab/ipilimumab: Not oligometastatic and tumor is BRAF mutation negative
- Progression after 1L dabrafenib/trametinib: Not oligometastatic and patient is NOT a candidate for dual immunotherapy
- Progression after 1L PD-1 inhibitor monotherapy: Not oligometastatic and tumor is BRAF mutation negative
- Progression after 1L nivolumab/relatlimab: Not oligometastatic and tumor is BRAF mutation negative
Candidate Requirements & Exclusions
- Targeted tumor for potential resection and harvesting
- ECOG Performance Status of 0-1
- Adequate hematologic, renal, cardiac (baseline ECHO or MUGA) and pulmonary function
- Able to withstand lymphodepleting chemotherapy regimen
- Ability to tolerate high-dose IL-2
- No rapidly progressing disease
- No symptomatic or untreated brain metastases
- No active infection
- No significant immunosuppression
Administration & Logistics
- Administered only at approved Authorized Treatment Centers (ATC)
- Requires pre-medication 30-60 minutes before infusion with acetaminophen and a H1 antihistamine
- Requires lymphodepleting chemotherapy regimen (cyclophosphamide + fludarabine) daily for 7 days before infusion
- Requires post-infusion administration of IL-2 (aldesleukin) at 600,000 IU/kg every 8-12 hours for up to 6 doses in an inpatient unit
Safety & Risk Mitigation
- Boxed Warnings mandate monitoring for treatment-related mortality, prolonged severe cytopenia, severe infection, and cardiopulmonary/renal impairment
- Do not administer in women who are pregnant
- Lactation: Discuss risks/benefits of breastfeeding with provider