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melanoma (ML), pembrolizumab plus SoC , 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) 0.76 [0.41, 1.40]< 10%1 study (1/-)81.1 %NAnot evaluable crucial-
progression or deaths (PFS) 0.66 [0.40, 1.08]< 10%1 study (1/-)95.1 %NAnot evaluable important-
DOR 0.41 [0.20, 0.83]< 10%1 study (1/-)99.3 %NAnot evaluable non important-
objective responses (ORR) 0.68 [0.32, 1.47]> 10%1 study (1/-)16.6 %NAnot evaluable non important-

safety endpoints 00

AE (any grade) 2.03 [0.18, 23.06]< 10%1 study (1/-)28.5 %NAnot evaluable non important-
AE (grade 3-4) 2.44 [1.17, 5.12]< 10%1 study (1/-)0.9 %NAnot evaluable non important-
AE leading to death (grade 5) 4.10 [0.18, 92.93]< 10%1 study (1/-)19.1 %NAnot evaluable non important-
AE leading to treatment discontinuation (any grade) 2.58 [1.16, 5.75]< 10%1 study (1/-)1.0 %NAnot evaluable non important-
TRAE (any grade) 1.36 [0.29, 6.34]< 10%1 study (1/-)34.9 %NAnot evaluable non important-
TRAE (grade 3-4) 3.60 [1.67, 7.74]< 10%1 study (1/-)0.1 %NAnot evaluable non important-
TRAE leading to death (grade 5) 2.02 [0.07, 61.28]< 10%1 study (1/-)34.6 %NAnot evaluable non important-
TRAE leading to discontinuation (any grade) 2.67 [1.18, 6.03]< 10%1 study (1/-)0.9 %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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