KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma.
- 55% 2-year OS rate with KEYTRUDA vs 43% with ipilimumab.1,a
- Number of deaths observed in each arm: 119/277 (43%) and 122/279 (44%) with KEYTRUDA 10 mg/kg Q3W and Q2W, respectively, and 142/278 (51%) with ipilimumab1
- Median OS at 2-year analysis was not reached with KEYTRUDA vs 16 months with ipilimumab.1
- 37% 5-year OS rate with KEYTRUDA vs 31% with ipilimumab.2,b
- Number of deaths observed in each arm: 161/277 (58%) and 163/279 (58%) with KEYTRUDA 10 mg/kg Q3W and Q2W, respectively, and 172/278 (62%) with ipilimumab3
- Median OSb was 34.2 months with KEYTRUDA 10 mg/kg Q3W (95% CI, 23.5–42.7) and 31.1 months with KEYTRUDA 10 mg/kg Q2W (95% CI, 22.1–45.9) vs 15.9 months with ipilimumab (95% CI, 13.3–22.0).2
- Estimates of the survival distribution were generated using the Kaplan-Meier method.
Limitation:
- The 5-year extension of KEYNOTE-006 was a post-hoc exploratory analysis. No formal statistical testing was planned for the 5-year analysis and, therefore, no conclusions can be drawn.3
aKEYTRUDA 10 mg/kg Q3W.
bFrom product-limit (Kaplan-Meier) method for censored data.
OS = overall survival; Q3W = every 3 weeks; HR = hazard ratio; Q2W = every 2 weeks; CI = confidence interval.
- Percentage of patients in KEYNOTE-006 who were treatment naїve was 67% (185/277) and 66% (183/279) with KEYTRUDA 10 mg/kg Q3W and Q2W, respectively, and 65% (181/278) with ipilimumab.2
- Patients were considered to be treatment-naїve if they had never undergone treatment for metastatic disease.3
Limitations:
- The post-hoc 5-year extension of KEYNOTE-006 was an exploratory analysis. No formal statistical testing was planned for the 5-year analysis and, therefore, no conclusions can be drawn.3
- KN-006 was not powered to detect differences in the treatment effect in these subgroups; therefore, results from exploratory analyses should be interpreted with caution because of the modest patient numbers and potential imbalances in baseline characteristics within the subgroups.2
Limitation:
- The 5-year extension of KEYNOTE-006 was an exploratory analysis. No formal statistical testing was planned for the 5-year analysis and, therefore, no conclusions can be drawn.3
Percentages have been rounded to the nearest whole integer.
cHR (KEYTRUDA compared to ipilimumab) based on the stratified Cox proportional hazard model.
dKEYTRUDA 10 mg/kg Q3W
eORR by BICR
fORR by irRC3
PFS = progression free survival; ORR = objective response rate; BICR = blinded independent central review; CR = complete response; PR = partial response; irRC = immune-related response criteria.
NCCN Guidelines® recommend pembrolizumab (KEYTRUDA) as an option for first‑line systemic therapy (category 1) or second- or subsequent-line systemic therapy (category 2A) for metastatic or unresectable melanoma.4
Category 1 = Based upon high-level evidence, there is uniform National Comprehensive Cancer Network® (NCCN®) consensus that the intervention is appropriate.2
Category 2A = Based on lower-level evidence, there is uniform NCCN consensus that the intervention is appropriate.4
NCCN makes no warranties of any kind whatsoever regarding their content, use, or application and disclaims any responsibility for their application or use in any way.
- An open-label, multicenter, active-controlled trial that included patients with unresectable or metastatic melanoma with
progression of disease, no prior ipilimumab, and no more than 1 prior systemic treatment for metastatic melanoma.
- Patients with BRAF V600E mutation-positive melanoma were not required to have received prior BRAF inhibitor therapy.
gPatients were treated with ipilimumab for 4 doses unless discontinued earlier for disease progression or unacceptable
toxicity.
hAs assessed by BICR using RECIST v1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ.
- Patients with disease progression could receive additional doses of KEYTRUDA unless disease progression was symptomatic, was rapidly progressive, required urgent intervention, occurred with a decline in performance status, or was confirmed at 4 to 6 weeks with repeat imaging.
- Assessment of tumor status was performed at 12 weeks, then every 6 weeks through week 48, followed by every 12 weeks thereafter.
BRAF = B-Raf proto-oncogene, serine/threonine kinase; PD-L1 = programmed death ligand 1; RECIST v1.1 = Response Evaluation Criteria In Solid Tumors v1.1.