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mNSCLC - L1 - all population, cemiplimab , 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 [0.53, 0.87]< 10%1 study (1/-)99.9 %NAnot evaluable crucial-
progression or deaths (PFS) 0.59 [0.49, 0.72]< 10%1 study (1/-)100.0 %NAnot evaluable important-
objective responses (ORR) 2.21 [1.58, 3.10]> 10%1 study (1/-)100.0 %NAnot evaluable non important-

safety endpoints 00

AE (any grade) 0.18 [0.12, 0.27]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
AE (grade 3-4) 0.19 [0.13, 0.29]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
AE leading to death (grade 5) 1.24 [0.46, 3.38]< 10%1 study (1/-)33.4 %NAnot evaluable non important-
AE leading to treatment discontinuation (any grade) 1.62 [0.82, 3.21]< 10%1 study (1/-)8.2 %NAnot evaluable non important-

TRAE (grade 3-4) endpoints 00

Colitis TRAE (grade 3-4) 0.96 [0.02, 48.69]< 10%1 study (1/-)50.7 %NAnot evaluable non important-
Diarrhoea TRAE (grade 3-4) 0.48 [0.02, 14.38]< 10%1 study (1/-)66.1 %NAnot evaluable non important-
Hepatitis TRAE (grade 3-4) 1.93 [0.06, 57.70]< 10%1 study (1/-)35.4 %NAnot evaluable non important-
Hyperthyroidism TRAE (grade 3-4) 0.96 [0.02, 48.69]< 10%1 study (1/-)50.7 %NAnot evaluable non important-
Hypothyroidism TRAE (grade 3-4) 0.96 [0.02, 48.69]< 10%1 study (1/-)50.7 %NAnot evaluable non important-
Increase AST TRAE (grade 3-4) 3.87 [0.17, 86.12]< 10%1 study (1/-)19.9 %NAnot evaluable non important-
Increased ALT TRAE (grade 3-4) 1.93 [0.06, 57.70]< 10%1 study (1/-)35.4 %NAnot evaluable non important-
Maculopapular rash TRAE (grade 3-4) 1.93 [0.06, 57.70]< 10%1 study (1/-)35.4 %NAnot evaluable non important-
Nephritis TRAE (grade 3-4) 0.96 [0.02, 48.69]< 10%1 study (1/-)50.7 %NAnot evaluable non important-
Peripheral neuropathy TRAE (grade 3-4) 1.93 [0.06, 57.70]< 10%1 study (1/-)35.4 %NAnot evaluable non important-
Pneumonitis TRAE (grade 3-4) 1.93 [0.06, 57.70]< 10%1 study (1/-)35.4 %NAnot evaluable non important-
Rash TRAE (grade 3-4) 3.87 [0.17, 86.12]< 10%1 study (1/-)19.9 %NAnot evaluable non important-

AE (grade 3-4) endpoints 00

hepatitis (Autoimmune) AE (grade 3-4) 1.93 [0.06, 57.70]< 10%1 study (1/-)35.4 %NAnot evaluable non important-
Acute kidney injury AE (grade 3-4) 0.24 [0.01, 5.34]< 10%1 study (1/-)81.4 %NAnot evaluable non important-
Alopecia AE (grade 3-4) 0.24 [0.01, 5.34]< 10%1 study (1/-)81.4 %NAnot evaluable non important-
Anaemia AE (grade 3-4) 0.03 [0.01, 0.13]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
Arthralgia AE (grade 3-4) 0.48 [0.02, 14.38]< 10%1 study (1/-)66.1 %NAnot evaluable non important-
Asthenia AE (grade 3-4) 0.48 [0.02, 14.38]< 10%1 study (1/-)66.1 %NAnot evaluable non important-
Back pain AE (grade 3-4) 0.48 [0.02, 14.38]< 10%1 study (1/-)66.1 %NAnot evaluable non important-
Blood creatinine increased AE (grade 3-4) 0.48 [0.02, 14.38]< 10%1 study (1/-)66.1 %NAnot evaluable non important-
Constipation AE (grade 3-4) 0.96 [0.02, 48.69]< 10%1 study (1/-)50.7 %NAnot evaluable non important-
Decreased appetite AE (grade 3-4) 0.96 [0.06, 15.46]< 10%1 study (1/-)51.0 %NAnot evaluable non important-
Diarrhoea AE (grade 3-4) 0.16 [0.02, 1.32]< 10%1 study (1/-)95.5 %NAnot evaluable non important-
Dyspnoea AE (grade 3-4) 1.93 [0.17, 21.41]< 10%1 study (1/-)29.7 %NAnot evaluable non important-
Fatigue AE (grade 3-4) 0.72 [0.16, 3.24]< 10%1 study (1/-)66.5 %NAnot evaluable non important-
Febrile neutropenia AE (grade 3-4) 0.06 [0.00, 1.03]< 10%1 study (1/-)97.3 %NAnot evaluable non important-
Hypertension AE (grade 3-4) 0.24 [0.01, 5.34]< 10%1 study (1/-)81.4 %NAnot evaluable non important-
Increase AST AE (grade 3-4) 4.87 [0.57, 41.91]< 10%1 study (1/-)7.6 %NAnot evaluable non important-
Increased ALT AE (grade 3-4) 5.82 [0.29, 116.64]< 10%1 study (1/-)12.7 %NAnot evaluable non important-
Increased Lipase Level AE (grade 3-4) 1.93 [0.06, 57.70]< 10%1 study (1/-)35.4 %NAnot evaluable non important-
Leucopenia AE (grade 3-4) 0.10 [0.01, 0.83]< 10%1 study (1/-)98.3 %NAnot evaluable non important-
myocarditis AE (grade 3-4) 0.96 [0.02, 48.69]< 10%1 study (1/-)50.7 %NAnot evaluable non important-
Nausea AE (grade 3-4) 0.12 [0.01, 2.26]< 10%1 study (1/-)91.9 %NAnot evaluable non important-
Neutropenia AE (grade 3-4) 0.05 [0.01, 0.21]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
Pancytopenia (AE grade 3-4) 0.48 [0.02, 14.38]< 10%1 study (1/-)66.1 %NAnot evaluable non important-
Peripheral neuropathy AE (grade 3-4) 0.96 [0.06, 15.46]< 10%1 study (1/-)51.0 %NAnot evaluable non important-
Peripheral sensory neuropathy AE (grade 3-4) 0.48 [0.02, 14.38]< 10%1 study (1/-)66.1 %NAnot evaluable non important-
Pneumonia AE (grade 3-4) 0.77 [0.20, 2.88]< 10%1 study (1/-)65.2 %NAnot evaluable non important-
Pneumonitis AE (grade 3-4) 1.93 [0.06, 57.70]< 10%1 study (1/-)35.4 %NAnot evaluable non important-
Rash AE (grade 3-4) 5.82 [0.29, 116.64]< 10%1 study (1/-)12.7 %NAnot evaluable non important-
Rash maculopapular AE (grade 3-4) 1.93 [0.06, 57.70]< 10%1 study (1/-)35.4 %NAnot evaluable non important-
Stomatitis AE (grade 3-4) 0.48 [0.02, 14.38]< 10%1 study (1/-)66.1 %NAnot evaluable non important-
Thrombocytopenia AE (grade 3-4) 0.02 [0.00, 0.30]< 10%1 study (1/-)99.7 %NAnot evaluable non important-
Vomiting AE (grade 3-4) 0.12 [0.01, 2.26]< 10%1 study (1/-)91.9 %NAnot evaluable non important-
Weight decreased AE (grade 3-4) 1.93 [0.06, 57.70]< 10%1 study (1/-)35.4 %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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