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mML - 2nd line (L2), pembrolizumab (10mg/kg) 2 weeks , 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) 0.63 [0.47, 0.84]< 10%1 study (1/-)99.9 %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 [0.46, 0.73]< 10%1 study (1/-)100.0 %NAnot evaluable important-
objective responses (ORR) 3.77 [2.43, 5.86]> 10%1 study (1/-)100.0 %NAnot evaluable non important-

safety endpoints 00

STRAE (any grade) 0.67 [0.41, 1.09]< 10%1 study (1/-)94.7 %NAnot evaluable non important-
STRAE (grade 3-4) 0.92 [0.02, 46.58]< 10%1 study (1/-)51.6 %NAnot evaluable non important-
TRAE (any grade) 1.62 [1.07, 2.46]< 10%1 study (1/-)1.1 %NAnot evaluable non important-
TRAE (grade 3-4) 0.84 [0.54, 1.30]< 10%1 study (1/-)78.4 %NAnot evaluable non important-
TRAE leading to death (grade 5) 1.84 [0.06, 55.23]< 10%1 study (1/-)36.4 %NAnot evaluable non important-
TRAE leading to discontinuation (any grade) 0.74 [0.39, 1.40]< 10%1 study (1/-)82.1 %NAnot evaluable non important-
TRAE leading to discontinuation (grade 3-4) 0.92 [0.02, 46.58]< 10%1 study (1/-)51.6 %NAnot evaluable non important-

TRAE (grade 3-4) endpoints 00

Abdominal pain TRAE (grade 3-4) 0.92 [0.02, 46.58]< 10%1 study (1/-)51.6 %NAnot evaluable non important-
Alopecia TRAE (grade 3-4) 0.92 [0.02, 46.58]< 10%1 study (1/-)51.6 %NAnot evaluable non important-
Anaemia TRAE (grade 3-4) 1.85 [0.17, 20.50]< 10%1 study (1/-)31.0 %NAnot evaluable non important-
Arthralgia TRAE (grade 3-4) 0.92 [0.02, 46.58]< 10%1 study (1/-)51.6 %NAnot evaluable non important-
Asthenia TRAE (grade 3-4) 0.46 [0.04, 5.09]< 10%1 study (1/-)73.6 %NAnot evaluable non important-
Chills TRAE (grade 3-4) 0.92 [0.02, 46.58]< 10%1 study (1/-)51.6 %NAnot evaluable non important-
Colitis TRAE (grade 3-4) 0.19 [0.06, 0.58]< 10%1 study (1/-)99.8 %NAnot evaluable non important-
Constipation TRAE (grade 3-4) 0.92 [0.02, 46.58]< 10%1 study (1/-)51.6 %NAnot evaluable non important-
Cough TRAE (grade 3-4) 0.92 [0.02, 46.58]< 10%1 study (1/-)51.6 %NAnot evaluable non important-
Decreased appetite TRAE (grade 3-4) 0.92 [0.02, 46.58]< 10%1 study (1/-)51.6 %NAnot evaluable non important-
Diarrhoea TRAE (grade 3-4) 0.92 [0.32, 2.66]< 10%1 study (1/-)56.2 %NAnot evaluable non important-
Dry skin TRAE (grade 3-4) 0.92 [0.02, 46.58]< 10%1 study (1/-)51.6 %NAnot evaluable non important-
Dyspnoea TRAE (grade 3-4) 0.46 [0.02, 13.75]< 10%1 study (1/-)67.1 %NAnot evaluable non important-
Fatigue TRAE (grade 3-4) 0.30 [0.03, 2.95]< 10%1 study (1/-)84.6 %NAnot evaluable non important-
Headache TRAE (grade 3-4) 0.92 [0.02, 46.58]< 10%1 study (1/-)51.6 %NAnot evaluable non important-
Hepatitis TRAE (grade 3-4) 2.78 [0.29, 26.92]< 10%1 study (1/-)19.0 %NAnot evaluable non important-
Hyperthyroidism TRAE (grade 3-4) 0.46 [0.02, 13.75]< 10%1 study (1/-)67.1 %NAnot evaluable non important-
Hypophysitis TRAE (grade 3-4) 0.23 [0.01, 5.10]< 10%1 study (1/-)82.1 %NAnot evaluable non important-
Hypothyroidism TRAE (grade 3-4) 1.84 [0.06, 55.23]< 10%1 study (1/-)36.4 %NAnot evaluable non important-
Increase AST TRAE (grade 3-4) 0.23 [0.01, 5.10]< 10%1 study (1/-)82.1 %NAnot evaluable non important-
Increased ALT TRAE (grade 3-4) 0.23 [0.01, 5.10]< 10%1 study (1/-)82.1 %NAnot evaluable non important-
Maculopapular rash TRAE (grade 3-4) 0.46 [0.02, 13.75]< 10%1 study (1/-)67.1 %NAnot evaluable non important-
Myalgia TRAE (grade 3-4) 0.92 [0.06, 14.80]< 10%1 study (1/-)52.3 %NAnot evaluable non important-
Myositis TRAE (grade 3-4) 0.92 [0.02, 46.58]< 10%1 study (1/-)51.6 %NAnot evaluable non important-
Nausea TRAE (grade 3-4) 0.92 [0.02, 46.58]< 10%1 study (1/-)51.6 %NAnot evaluable non important-
Nephritis TRAE (grade 3-4) 0.46 [0.02, 13.75]< 10%1 study (1/-)67.1 %NAnot evaluable non important-
Neutropenia TRAE (grade 3-4) 0.92 [0.02, 46.58]< 10%1 study (1/-)51.6 %NAnot evaluable non important-
Paraesthesia TRAE (grade 3-4) 0.46 [0.02, 13.75]< 10%1 study (1/-)67.1 %NAnot evaluable non important-
Pneumonitis TRAE (grade 3-4) 0.46 [0.02, 13.75]< 10%1 study (1/-)67.1 %NAnot evaluable non important-
Pruritic rash TRAE (grade 3-4) 0.92 [0.02, 46.58]< 10%1 study (1/-)51.6 %NAnot evaluable non important-
Pruritus TRAE (grade 3-4) 0.92 [0.02, 46.58]< 10%1 study (1/-)51.6 %NAnot evaluable non important-
Pyrexia TRAE (grade 3-4) 0.92 [0.02, 46.58]< 10%1 study (1/-)51.6 %NAnot evaluable non important-
Rash TRAE (grade 3-4) 0.92 [0.02, 46.58]< 10%1 study (1/-)51.6 %NAnot evaluable non important-
Uveitis TRAE (grade 3-4) 0.92 [0.02, 46.58]< 10%1 study (1/-)51.6 %NAnot evaluable non important-
Vomiting TRAE (grade 3-4) 1.84 [0.06, 55.23]< 10%1 study (1/-)36.4 %NAnot evaluable non important-
Weight decreased TRAE (grade 3-4) 0.46 [0.02, 13.75]< 10%1 study (1/-)67.1 %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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