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melanoma (ML), pembrolizumab (10mg/kg) versus ipilimumab alone, meta-analysis of study results

Outcome Relative effect 95%CI LoD Trt. better when I2 k (RCT/OBS) Bayesian probability Overall ROB Publication bias Degree of certainty Endpoint importance Published MA

efficacy endpoints 00

deaths (OS) 0.69 [0.52, 0.91]< 10%1 study (1/-)99.6 %NAnot evaluable crucial-
deaths (OS) (extension) 0.68 [0.53, 0.87]< 10%1 study (1/-)99.9 %NAnot evaluable important-
PFS (extension) 0.61 [0.50, 0.75]< 10%1 study (1/-)100.0 %NAnot evaluable important-
progression or deaths (PFS) 0.58 [0.47, 0.72]< 10%1 study (1/-)100.0 %NAnot evaluable important-
objective responses (ORR) 3.63 [2.34, 5.65]> 10%1 study (1/-)100.0 %NAnot evaluable non important-

safety endpoints 00

STRAE (any grade) 0.63 [0.39, 1.03]< 10%1 study (1/-)96.8 %NAnot evaluable non important-
STRAE (grade 3-4) 0.92 [0.02, 46.74]< 10%1 study (1/-)51.5 %NAnot evaluable non important-
TRAE (any grade) 1.16 [0.78, 1.72]< 10%1 study (1/-)23.6 %NAnot evaluable non important-
TRAE (grade 3-4) 0.82 [0.53, 1.28]< 10%1 study (1/-)81.0 %NAnot evaluable non important-
TRAE leading to death (grade 5) 0.92 [0.02, 46.74]< 10%1 study (1/-)51.5 %NAnot evaluable non important-
TRAE leading to discontinuation (any grade) 1.23 [0.69, 2.18]< 10%1 study (1/-)23.9 %NAnot evaluable non important-
TRAE leading to discontinuation (grade 3-4) 0.92 [0.02, 46.74]< 10%1 study (1/-)51.5 %NAnot evaluable non important-

TRAE (grade 3-4) endpoints 00

Abdominal pain TRAE (grade 3-4) 0.92 [0.02, 46.74]< 10%1 study (1/-)51.5 %NAnot evaluable non important-
Alopecia TRAE (grade 3-4) 0.92 [0.02, 46.74]< 10%1 study (1/-)51.5 %NAnot evaluable non important-
Anaemia TRAE (grade 3-4) 0.46 [0.02, 13.80]< 10%1 study (1/-)67.0 %NAnot evaluable non important-
Arthralgia TRAE (grade 3-4) 0.92 [0.02, 46.74]< 10%1 study (1/-)51.5 %NAnot evaluable non important-
Asthenia TRAE (grade 3-4) 0.23 [0.01, 5.12]< 10%1 study (1/-)82.1 %NAnot evaluable non important-
Chills TRAE (grade 3-4) 0.92 [0.02, 46.74]< 10%1 study (1/-)51.5 %NAnot evaluable non important-
Colitis TRAE (grade 3-4) 0.34 [0.14, 0.83]< 10%1 study (1/-)99.1 %NAnot evaluable non important-
Constipation TRAE (grade 3-4) 0.92 [0.02, 46.74]< 10%1 study (1/-)51.5 %NAnot evaluable non important-
Cough TRAE (grade 3-4) 0.92 [0.02, 46.74]< 10%1 study (1/-)51.5 %NAnot evaluable non important-
Decreased appetite TRAE (grade 3-4) 0.92 [0.02, 46.74]< 10%1 study (1/-)51.5 %NAnot evaluable non important-
Diabetes TRAE (grade 3-4) 1.85 [0.06, 55.43]< 10%1 study (1/-)36.3 %NAnot evaluable non important-
Diarrhoea TRAE (grade 3-4) 0.39 [0.10, 1.52]< 10%1 study (1/-)91.2 %NAnot evaluable non important-
Dry skin TRAE (grade 3-4) 0.92 [0.02, 46.74]< 10%1 study (1/-)51.5 %NAnot evaluable non important-
Dyspnoea TRAE (grade 3-4) 0.92 [0.06, 14.85]< 10%1 study (1/-)52.2 %NAnot evaluable non important-
Fatigue TRAE (grade 3-4) 0.92 [0.18, 4.62]< 10%1 study (1/-)53.9 %NAnot evaluable non important-
Headache TRAE (grade 3-4) 0.92 [0.02, 46.74]< 10%1 study (1/-)51.5 %NAnot evaluable non important-
Hepatitis TRAE (grade 3-4) 4.69 [0.54, 40.40]< 10%1 study (1/-)8.1 %NAnot evaluable non important-
Hyperthyroidism TRAE (grade 3-4) 0.46 [0.02, 13.80]< 10%1 study (1/-)67.0 %NAnot evaluable non important-
Hypophysitis TRAE (grade 3-4) 0.46 [0.04, 5.11]< 10%1 study (1/-)73.5 %NAnot evaluable non important-
Hypothyroidism TRAE (grade 3-4) 0.92 [0.02, 46.74]< 10%1 study (1/-)51.5 %NAnot evaluable non important-
Increase AST TRAE (grade 3-4) 0.46 [0.04, 5.11]< 10%1 study (1/-)73.5 %NAnot evaluable non important-
Increased ALT TRAE (grade 3-4) 0.46 [0.04, 5.11]< 10%1 study (1/-)73.5 %NAnot evaluable non important-
Maculopapular rash TRAE (grade 3-4) 0.92 [0.06, 14.85]< 10%1 study (1/-)52.2 %NAnot evaluable non important-
Myalgia TRAE (grade 3-4) 0.46 [0.02, 13.80]< 10%1 study (1/-)67.0 %NAnot evaluable non important-
Myositis TRAE (grade 3-4) 0.92 [0.02, 46.74]< 10%1 study (1/-)51.5 %NAnot evaluable non important-
Nausea TRAE (grade 3-4) 0.92 [0.02, 46.74]< 10%1 study (1/-)51.5 %NAnot evaluable non important-
Nephritis TRAE (grade 3-4) 0.46 [0.02, 13.80]< 10%1 study (1/-)67.0 %NAnot evaluable non important-
Neutropenia TRAE (grade 3-4) 0.92 [0.02, 46.74]< 10%1 study (1/-)51.5 %NAnot evaluable non important-
Paraesthesia TRAE (grade 3-4) 0.46 [0.02, 13.80]< 10%1 study (1/-)67.0 %NAnot evaluable non important-
Pneumonitis TRAE (grade 3-4) 0.92 [0.06, 14.85]< 10%1 study (1/-)52.2 %NAnot evaluable non important-
Pruritic rash TRAE (grade 3-4) 0.92 [0.02, 46.74]< 10%1 study (1/-)51.5 %NAnot evaluable non important-
Pruritus TRAE (grade 3-4) 0.92 [0.02, 46.74]< 10%1 study (1/-)51.5 %NAnot evaluable non important-
Pyrexia TRAE (grade 3-4) 0.92 [0.02, 46.74]< 10%1 study (1/-)51.5 %NAnot evaluable non important-
Rash TRAE (grade 3-4) 0.92 [0.02, 46.74]< 10%1 study (1/-)51.5 %NAnot evaluable non important-
Uveitis TRAE (grade 3-4) 0.92 [0.02, 46.74]< 10%1 study (1/-)51.5 %NAnot evaluable non important-
Vomiting TRAE (grade 3-4) 0.92 [0.02, 46.74]< 10%1 study (1/-)51.5 %NAnot evaluable non important-
Weight decreased TRAE (grade 3-4) 0.46 [0.02, 13.80]< 10%1 study (1/-)67.0 %NAnot evaluable non important-

LoD: level of statistical demonstration: Statistically conclusive: statistically significant with a strict control of overall risk of type 1 error (statistically demonstrated), does not take into account the risk of bias; suggested: nominally statistically significant but without a strict control of overall risk of type 1 error; inconclusive: not nominally statistically significant; safety concerns;
Bayesian probability: Bayesian posterior probability of treatment effect (computed with a noninformative prior); ROB: risk of bias; k: number of studies; published MA: number of published meta-analysis on the same topic; degree of certainty adapted from GRADE. Trt. better when: indicates when the relative treatment effect shows that the studied treatment is better than control.



 

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