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mML - 2nd line (L2), ipilimumab plus gp100 versus gp100, 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) 0.68 [0.55, 0.85]< 10%1 study (1/-)100.0 %NAnot evaluable crucial-
DOR 0.68 [0.55, 0.85]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
objective responses (ORR) 4.06 [0.94, 17.43]> 10%1 study (1/-)97.0 %NAnot evaluable non important-

safety endpoints 00

AE (any grade) 1.95 [0.54, 7.01]< 10%1 study (1/-)15.4 %NAnot evaluable non important-
AE (grade 3-4) 0.94 [0.63, 1.40]< 10%1 study (1/-)61.3 %NAnot evaluable non important-
TRAE (any grade) 2.17 [1.28, 3.67]< 10%1 study (1/-)0.2 %NAnot evaluable non important-
TRAE (grade 3-4) 1.64 [0.90, 2.99]< 10%1 study (1/-)5.3 %NAnot evaluable non important-
TRAE leading to death (grade 5) 1.36 [0.28, 6.47]< 10%1 study (1/-)35.1 %NAnot evaluable non important-

TRAE (grade 3-4) endpoints 00

Adrenal insufficiency TRAE (grade 3-4) 1.39 [0.06, 31.06]< 10%1 study (1/-)41.8 %NAnot evaluable non important-
Colitis TRAE (grade 3-4) 8.58 [0.50, 146.20]< 10%1 study (1/-)7.1 %NAnot evaluable non important-
Diarrhoea TRAE (grade 3-4) 5.01 [0.65, 38.48]< 10%1 study (1/-)6.2 %NAnot evaluable non important-
Endocrine disorders TRAE (grade 3-4) 2.80 [0.15, 53.28]< 10%1 study (1/-)24.9 %NAnot evaluable non important-
Gastrointestinal disorders TRAE (grade 3-4) 8.05 [1.07, 60.32]< 10%1 study (1/-)2.2 %NAnot evaluable non important-
Hepatitis TRAE (grade 3-4) 0.69 [0.02, 20.81]< 10%1 study (1/-)58.2 %NAnot evaluable non important-
Hepatobiliary disorders TRAE (grade 3-4) 0.46 [0.10, 2.07]< 10%1 study (1/-)84.4 %NAnot evaluable non important-
Hypophysitis TRAE (grade 3-4) 1.39 [0.06, 31.06]< 10%1 study (1/-)41.8 %NAnot evaluable non important-
Hypothyroidism TRAE (grade 3-4) 0.69 [0.02, 20.81]< 10%1 study (1/-)58.2 %NAnot evaluable non important-
Increase AST TRAE (grade 3-4) 0.17 [0.02, 1.91]< 10%1 study (1/-)92.3 %NAnot evaluable non important-
Increased ALT TRAE (grade 3-4) 1.39 [0.06, 31.06]< 10%1 study (1/-)41.8 %NAnot evaluable non important-
Pruritus TRAE (grade 3-4) 0.69 [0.02, 20.81]< 10%1 study (1/-)58.2 %NAnot evaluable non important-
Rash TRAE (grade 3-4) 3.51 [0.19, 64.62]< 10%1 study (1/-)20.2 %NAnot evaluable non important-
Skin and subcutaneous tissue disorders TRAE (grade 3-4) 6.38 [0.37, 110.82]< 10%1 study (1/-)10.4 %NAnot evaluable non important-
Vitiligo TRAE (grade 3-4) 0.35 [0.01, 17.55]< 10%1 study (1/-)69.8 %NAnot evaluable non important-

AE (grade 3-4) endpoints 00

Abdominal pain AE (grade 3-4) 0.29 [0.09, 0.87]< 10%1 study (1/-)98.6 %NAnot evaluable non important-
Anaemia AE (grade 3-4) 0.33 [0.14, 0.78]< 10%1 study (1/-)99.4 %NAnot evaluable non important-
Constipation AE (grade 3-4) 1.04 [0.11, 10.11]< 10%1 study (1/-)48.6 %NAnot evaluable non important-
Cough AE (grade 3-4) 0.69 [0.02, 20.81]< 10%1 study (1/-)58.2 %NAnot evaluable non important-
Decreased appetite AE (grade 3-4) 0.51 [0.14, 1.85]< 10%1 study (1/-)84.6 %NAnot evaluable non important-
Diarrhoea AE (grade 3-4) 6.13 [0.81, 46.56]< 10%1 study (1/-)4.0 %NAnot evaluable non important-
Dyspnoea AE (grade 3-4) 0.80 [0.30, 2.14]< 10%1 study (1/-)67.0 %NAnot evaluable non important-
Fatigue AE (grade 3-4) 1.68 [0.56, 5.04]< 10%1 study (1/-)17.6 %NAnot evaluable non important-
Headache AE (grade 3-4) 0.46 [0.10, 2.07]< 10%1 study (1/-)84.4 %NAnot evaluable non important-
Nausea AE (grade 3-4) 0.69 [0.17, 2.80]< 10%1 study (1/-)69.8 %NAnot evaluable non important-
Pyrexia AE (grade 3-4) 0.34 [0.05, 2.47]< 10%1 study (1/-)85.5 %NAnot evaluable non important-
Vomiting AE (grade 3-4) 0.81 [0.21, 3.17]< 10%1 study (1/-)62.0 %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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