Patients were allowed to receive prior adjuvant and neoadjuvant melanoma therapy.
Anti–PD-1, anti–CTLA-4, or BRAF-MEK therapy was allowed as long as there was at least 6 months between the last dose of therapy and date of recurrence; interferon therapy was allowed as long as the last dose was at least 6 weeks prior to randomization.

Indication:

Opdualag is indicated for the first-line treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older with tumour cell PD-L1 expression < 1%.

Inclusion criteria:

• Histologically confirmed Stage III (unresectable) or Stage IV melanoma per the AJCC staging system
• No prior systemic anticancer therapy for unresectable melanoma
• Tumor tissue from an unresectable or metastatic site of disease must be provided for biomarker analyses
• Patients were eligible regardless of BRAF status

Exclusion criteria:

• Patients with active autoimmune disease
• Medical conditions requiring systemic treatment with moderate- or high-dose corticosteroids or immunosuppressive medications
• Patients with uveal melanoma
• Patients with active or untreated brain or leptomeningeal metastases

^†PD-L1 expression (≥1% vs <1%) using PD-L1 IHC 28-8 pharmDx test.
^‡LAG-3 expression (≥1% vs <1%) using a clinical trial assay.
^§The final analysis of OS was not statistically significant.

ITT-population. EU approved indication: PD-L1 <1%.
BICR = blinded independent central review; ECOG = European Cooperative Oncology Group; q4w = every 4 weeks.

Reference: 

1. Tawbi et al. N Engl J Med 2022;386:24–34.
2. Opdualag SmPC