aStaging according to AJCC 7th ed.
PD-1 = programmed death receptor-1; AJCC = American Joint Committee on Cancer; 1L = first-line treatment; 2L = second-line treatment.
No prior systemic therapy
66%
- Among patients with BRAF mutation-positive melanoma:
- 139 (46%) were previously treated with a BRAF inhibitor.
- 161 (54%) were BRAF inhibitor naïve.
- The study included patients with both PD-L1–positive and –negative melanoma, using a 1% cutoff for PD‑L1 statusc:
- 80% of patients had PD-L1–positive melanoma.
- 18% of patients had PD-L1–negative melanoma.
- 2% had unknown PD-L1 status.
Stage IIIAa
(with >1 mm lymph node metastasis)
16%
Stage IIICa
(1–3 positive lymph nodes)
18%
Stage IIICa
(≥4 positive lymph nodes)
20%
- The RFS benefit for KEYTRUDA compared to placebo was observed regardless of tumor PD-L1 expression.
bOf the 834 patients in KEYNOTE-006, 60% were male, the median age was 62 years (range: 18–89), 98% were white, 69% had an ECOG PS of 0, 68% had normal LDH, and 9% had a history of brain metastases.
cPD-L1 expression (≥1% of tumor cells [positive] vs <1% of tumor cells [negative]) according to an investigational use–only assay.
dOf the 1,019 patients in KEYNOTE-054, 62% were male, the median age was 54 years (25% were 65 or older), and 94% had an ECOG PS of 0.
BRAF = B-Raf proto-oncogene, serine/threonine kinase; LDH = lactate dehydrogenase; PD-L1 = programmed death ligand 1; RFS = recurrence-free survival;
ECOG PS = Eastern Cooperative Oncology Group performance status.