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metastatic/adv melanoma (mML), pembrolizumab (10mg/kg) , 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) 0.72 [0.59, 0.86]< 10%2 studies (2/-)100.0 %some concernnot evaluable moderatecrucial-
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) 0.54 [0.46, 0.64]< 10%2 studies (2/-)100.0 %some concernnot evaluable moderateimportant-
objective responses (ORR) 5.09 [2.33, 11.13]> 168%2 studies (2/-)100.0 %some concernnot evaluable moderatenon 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) 0.97 [0.64, 1.46]< 140%2 studies (2/-)56.6 %some concernnot evaluable moderatenon important-
TRAE (grade 3-4) 0.68 [0.46, 1.02]< 129%2 studies (2/-)96.8 %some concernnot evaluable moderatenon important-
TRAE leading to death (grade 5) 1.40 [0.11, 18.31]< 10%2 studies (2/-)39.9 %some concernnot evaluable moderatenon important-
TRAE leading to discontinuation (any grade) 1.35 [0.84, 2.17]< 10%2 studies (2/-)11.0 %some concernnot evaluable moderatenon important-
TRAE leading to discontinuation (grade 3-4) 2.50 [0.82, 7.64]< 10%2 studies (2/-)5.4 %some concernnot evaluable moderatenon 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) 0.94 [0.06, 15.07]< 10%2 studies (2/-)51.7 %some concernnot evaluable moderatenon important-
Anaemia TRAE (grade 3-4) 0.13 [0.01, 1.12]< 10%2 studies (2/-)96.8 %some concernnot evaluable moderatenon important-
Arthralgia TRAE (grade 3-4) 0.94 [0.10, 9.13]< 10%2 studies (2/-)52.0 %some concernnot evaluable moderatenon important-
Asthenia TRAE (grade 3-4) 0.51 [0.06, 4.02]< 10%2 studies (2/-)73.9 %some concernnot evaluable moderatenon 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) 0.76 [0.10, 5.79]< 166%2 studies (2/-)60.3 %some concernnot evaluable moderatenon important-
Constipation TRAE (grade 3-4) 0.94 [0.06, 15.07]< 10%2 studies (2/-)51.7 %some concernnot evaluable moderatenon 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) 0.94 [0.06, 15.07]< 10%2 studies (2/-)51.7 %some concernnot evaluable moderatenon 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) 0.67 [0.21, 2.15]< 124%2 studies (2/-)74.7 %some concernnot evaluable moderatenon important-
Dry skin TRAE (grade 3-4) 0.94 [0.06, 15.07]< 10%2 studies (2/-)51.7 %some concernnot evaluable moderatenon 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) 0.45 [0.12, 1.77]< 132%2 studies (2/-)87.1 %some concernnot evaluable moderatenon 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) 4.40 [0.75, 25.82]< 10%2 studies (2/-)5.1 %some concernnot evaluable moderatenon important-
Hyperthyroidism TRAE (grade 3-4) 0.63 [0.05, 8.23]< 10%2 studies (2/-)63.7 %some concernnot evaluable moderatenon important-
Hypophysitis TRAE (grade 3-4) 0.56 [0.07, 4.37]< 10%2 studies (2/-)70.8 %some concernnot evaluable moderatenon important-
Hypothyroidism TRAE (grade 3-4) 0.94 [0.06, 15.07]< 10%2 studies (2/-)51.7 %some concernnot evaluable moderatenon 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-
Leucopenia TRAE (grade 3-4) 0.07 [0.00, 1.17]< 10%1 study (1/-)96.7 %NAnot evaluable non important-
Maculopapular rash TRAE (grade 3-4) 1.24 [0.14, 10.63]< 10%2 studies (2/-)42.4 %some concernnot evaluable moderatenon important-
Myalgia TRAE (grade 3-4) 0.47 [0.04, 5.19]< 10%2 studies (2/-)73.0 %some concernnot evaluable moderatenon 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) 0.33 [0.05, 2.22]< 10%2 studies (2/-)87.3 %some concernnot evaluable moderatenon 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) 0.18 [0.02, 1.90]< 10%2 studies (2/-)92.1 %some concernnot evaluable moderatenon important-
Pancreatitis TRAE (grade 3-4) 1.92 [0.06, 57.48]< 10%1 study (1/-)35.6 %NAnot evaluable non important-
Paraesthesia TRAE (grade 3-4) 0.63 [0.05, 8.23]< 10%2 studies (2/-)63.7 %some concernnot evaluable moderatenon important-
Peripheral neuropathy TRAE (grade 3-4) 0.24 [0.01, 5.29]< 10%1 study (1/-)81.5 %NAnot evaluable non important-
Pneumonitis TRAE (grade 3-4) 2.16 [0.28, 16.57]< 10%2 studies (2/-)23.1 %some concernnot evaluable moderatenon 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) 0.94 [0.06, 15.07]< 10%2 studies (2/-)51.7 %some concernnot evaluable moderatenon 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) 0.94 [0.06, 15.07]< 10%2 studies (2/-)51.7 %some concernnot evaluable moderatenon important-
Thrombocytopenia TRAE (grade 3-4) 0.23 [0.03, 2.12]< 10%1 study (1/-)90.0 %NAnot evaluable non important-
Uveitis TRAE (grade 3-4) 1.40 [0.11, 18.31]< 10%2 studies (2/-)39.9 %some concernnot evaluable moderatenon important-
Vitiligo TRAE (grade 3-4) 0.96 [0.02, 48.41]< 10%1 study (1/-)50.9 %NAnot evaluable non important-
Vomiting TRAE (grade 3-4) 0.33 [0.05, 2.22]< 10%2 studies (2/-)87.3 %some concernnot evaluable moderatenon 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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