Pembrolizumab monotherapy (advanced/metastatic melanoma, 1L; KEYNOTE-006)

Deterministic view of the source YAML entity. Clinical authority remains with the cited source IDs and reviewer sign-off state.

Knowledge-base record for audit. Provisional clinical content: this is not a prescription. An oncologist must verify original sources, applicability and review status. Full rules and constraints are in the YAML.

Source YAML: complete record

Components	`DRUG-PEMBROLIZUMAB`

ID	`REG-PEMBRO-MONO-MELANOMA`
Type	Regimen
Status	reviewed 2026-04-30 \| pending_clinical_signoff
Diseases	None declared
Sources	`SRC-ESMO-MELANOMA-2024` `SRC-KEYNOTE-006-ROBERT-2015` `SRC-NCCN-MELANOMA-2025`

Notes

KEYNOTE-006 (Robert NEJM 2015 + Lancet Oncol 2023 7-yr update): pembrolizumab Q2W or Q3W vs ipilimumab in 1L unresectable / metastatic melanoma (n=834). 6-mo PFS 47% vs 26% (HR 0.58); 12-mo OS 74% vs 58% (HR 0.69). 7-yr OS ~37% pembro vs ~25% ipi. PD-L1-agnostic; basis for FDA approval Dec 2015. Single-agent anti-PD-1 is preferred when ipi+nivo combination toxicity is unacceptable (irAE-frail, autoimmune comorbidity, advanced age, ECOG 2). Lower G3-4 irAE rate (~17%) vs ipi+nivo (~55%). Long-tail responders typical of IO.

Used By

Handbook Chapters

HB-MELANOMA-METASTATIC-1L - Metastatic melanoma: BRAF / IO first-line reasoning

Indication

IND-MELANOMA-METASTATIC-1L-PEMBRO-MONO - IND-MELANOMA-METASTATIC-1L-PEMBRO-MONO