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lung cancer : non small cell (NSCLC), durvalumab plus tremelimumab , 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) 0.90 [0.78, 1.04]< 10%2 studies (2/-)92.8 %some concernnot evaluable moderatecrucial-
progression or deaths (PFS) 0.87 [0.65, 1.18]< 142%2 studies (2/-)81.3 %some concernnot evaluable moderateimportant-
objective responses (ORR) 1.36 [0.50, 3.70]> 177%2 studies (2/-)72.8 %some concernnot evaluable moderatenon important-

safety endpoints 00

AE (any grade) 0.53 [0.30, 0.91]< 10%2 studies (2/-)98.9 %some concernnot evaluable moderatenon important-
AE (grade 3-4) 0.88 [0.61, 1.27]< 144%2 studies (2/-)74.6 %some concernnot evaluable moderatenon important-
AE leading to death (grade 5) 1.93 [1.14, 3.29]< 10%2 studies (2/-)0.8 %some concernnot evaluable moderatenon important-
AE leading to treatment discontinuation (any grade) 1.33 [0.95, 1.84]< 10%2 studies (2/-)4.7 %some concernnot evaluable moderatenon important-
AE leading to treatment discontinuation (grade 3-4) 2.14 [1.32, 3.47]< 10%1 study (1/-)0.1 %NAnot evaluable non important-
SAE (any grade) 1.86 [1.31, 2.62]< 10%2 studies (2/-)0.0 %some concernnot evaluable moderatenon important-
STRAE (any grade) 1.52 [1.03, 2.24]< 10%1 study (1/-)1.7 %NAnot evaluable non important-
STRAE (grade 3-4) 1.43 [0.92, 2.21]< 10%1 study (1/-)5.6 %NAnot evaluable non important-
TRAE (any grade) 0.33 [0.25, 0.44]< 10%2 studies (2/-)100.0 %some concernnot evaluable moderatenon important-
TRAE (grade 3-4) 0.53 [0.40, 0.71]< 10%2 studies (2/-)100.0 %some concernnot evaluable moderatenon important-
TRAE leading to death (grade 5) 1.69 [0.45, 6.29]< 10%2 studies (2/-)21.7 %some concernnot evaluable moderatenon important-
TRAE leading to discontinuation (any grade) 1.55 [1.03, 2.32]< 10%2 studies (2/-)1.7 %some concernnot evaluable moderatenon important-
TRAE leading to discontinuation (grade 3-4) 2.95 [1.51, 5.78]< 10%1 study (1/-)0.1 %NAnot evaluable non important-

TRAE (grade 3-4) endpoints 00

Acute kidney injury TRAE (grade 3-4) 1.27 [0.04, 38.28]< 10%1 study (1/-)44.5 %NAnot evaluable non important-
Adrenal insufficiency TRAE (grade 3-4) 2.97 [0.31, 28.17]< 10%2 studies (2/-)17.3 %some concernnot evaluable moderatenon important-
Alopecia TRAE (grade 3-4) 0.95 [0.02, 47.95]< 10%1 study (1/-)51.0 %NAnot evaluable non important-
Anaemia TRAE (grade 3-4) 0.06 [0.00, 0.91]< 159%2 studies (2/-)97.7 %some concernnot evaluable moderatenon important-
Asthenia TRAE (grade 3-4) 0.24 [0.01, 4.80]< 146%2 studies (2/-)82.4 %some concernnot evaluable moderatenon important-
Colitis TRAE (grade 3-4) 7.43 [0.93, 59.26]< 10%2 studies (2/-)3.0 %some concernnot evaluable moderatenon important-
Constipation TRAE (grade 3-4) 0.47 [0.02, 14.16]< 10%1 study (1/-)66.4 %NAnot evaluable non important-
Decreased appetite TRAE (grade 3-4) 0.83 [0.27, 2.59]< 10%2 studies (2/-)62.7 %some concernnot evaluable moderatenon important-
Diabetes TRAE (grade 3-4) 1.90 [0.06, 56.82]< 10%1 study (1/-)35.8 %NAnot evaluable non important-
Diarrhoea TRAE (grade 3-4) 3.94 [1.13, 13.81]< 10%2 studies (2/-)1.6 %some concernnot evaluable moderatenon important-
Dyspnoea TRAE (grade 3-4) 2.56 [0.11, 57.33]< 10%1 study (1/-)27.9 %NAnot evaluable non important-
Fatigue TRAE (grade 3-4) 0.83 [0.36, 1.95]< 10%2 studies (2/-)66.2 %some concernnot evaluable moderatenon important-
Hepatitis TRAE (grade 3-4) 4.15 [0.64, 26.90]< 18%2 studies (2/-)6.8 %some concernnot evaluable moderatenon important-
Hypersensitivity TRAE (grade 3-4) 1.27 [0.04, 38.28]< 10%1 study (1/-)44.5 %NAnot evaluable non important-
Hypertension TRAE (grade 3-4) 1.27 [0.11, 14.23]< 10%1 study (1/-)42.2 %NAnot evaluable non important-
Hyperthyroidism TRAE (grade 3-4) 1.19 [0.09, 15.52]< 10%2 studies (2/-)44.8 %some concernnot evaluable moderatenon important-
Hypophysitis TRAE (grade 3-4) 1.56 [0.14, 17.23]< 10%2 studies (2/-)36.0 %some concernnot evaluable moderatenon important-
Hypothyroidism TRAE (grade 3-4) 2.55 [0.24, 27.62]< 10%2 studies (2/-)22.2 %some concernnot evaluable moderatenon important-
Increase AST TRAE (grade 3-4) 0.63 [0.01, 32.23]< 10%1 study (1/-)58.8 %NAnot evaluable non important-
Increased ALT TRAE (grade 3-4) 0.63 [0.04, 10.24]< 10%1 study (1/-)62.5 %NAnot evaluable non important-
Increased lipase level TRAE (grade 3-4) 0.63 [0.01, 32.23]< 10%1 study (1/-)58.8 %NAnot evaluable non important-
Infusion-related reactions TRAE (grade 3-4) 0.63 [0.01, 32.23]< 10%1 study (1/-)58.8 %NAnot evaluable non important-
Leucopenia TRAE (grade 3-4) 0.10 [0.01, 2.08]< 10%1 study (1/-)92.8 %NAnot evaluable non important-
Myositis TRAE (grade 3-4) 0.63 [0.01, 32.23]< 10%1 study (1/-)58.8 %NAnot evaluable non important-
Nausea TRAE (grade 3-4) 0.21 [0.03, 1.38]< 10%2 studies (2/-)94.6 %some concernnot evaluable moderatenon important-
Nephritis TRAE (grade 3-4) 0.95 [0.02, 47.95]< 10%1 study (1/-)51.0 %NAnot evaluable non important-
Neutropenia TRAE (grade 3-4) 0.02 [0.00, 0.13]< 10%2 studies (2/-)100.0 %some concernnot evaluable moderatenon important-
Pancreatitis TRAE (grade 3-4) 2.56 [0.11, 57.33]< 10%1 study (1/-)27.9 %NAnot evaluable non important-
Peripheral oedema TRAE (grade 3-4) 1.27 [0.04, 38.28]< 10%1 study (1/-)44.5 %NAnot evaluable non important-
Pneumonia TRAE (grade 3-4) 0.63 [0.01, 32.23]< 10%1 study (1/-)58.8 %NAnot evaluable non important-
Pneumonitis TRAE (grade 3-4) 7.30 [1.34, 39.79]< 10%2 studies (2/-)1.1 %some concernnot evaluable moderatenon important-
Pruritic rash TRAE (grade 3-4) 1.27 [0.04, 38.28]< 10%1 study (1/-)44.5 %NAnot evaluable non important-
Pruritus TRAE (grade 3-4) 0.78 [0.05, 12.45]< 10%2 studies (2/-)57.0 %some concernnot evaluable moderatenon important-
Pyrexia TRAE (grade 3-4) 0.32 [0.01, 9.50]< 10%1 study (1/-)74.3 %NAnot evaluable non important-
Rash TRAE (grade 3-4) 0.51 [0.08, 3.12]< 10%2 studies (2/-)76.8 %some concernnot evaluable moderatenon important-
Stomatitis TRAE (grade 3-4) 1.27 [0.04, 38.28]< 10%1 study (1/-)44.5 %NAnot evaluable non important-
Thrombocytopenia TRAE (grade 3-4) 0.06 [0.01, 0.46]< 10%2 studies (2/-)99.6 %some concernnot evaluable moderatenon important-
Thyroiditis TRAE (grade 3-4) 0.63 [0.01, 32.23]< 10%1 study (1/-)58.8 %NAnot evaluable non important-
Vomiting TRAE (grade 3-4) 0.13 [0.01, 1.14]< 10%2 studies (2/-)96.6 %some concernnot evaluable moderatenon important-
Weight decreased TRAE (grade 3-4) 1.27 [0.04, 38.28]< 10%1 study (1/-)44.5 %NAnot evaluable non important-

AE (grade 3-4) endpoints 00

Alopecia AE (grade 3-4) 0.95 [0.02, 47.95]< 10%1 study (1/-)51.0 %NAnot evaluable non important-
Anaemia AE (grade 3-4) 0.12 [0.05, 0.28]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
Asthenia AE (grade 3-4) 0.86 [0.36, 2.05]< 10%1 study (1/-)63.4 %NAnot evaluable non important-
Back pain AE (grade 3-4) 0.63 [0.10, 3.80]< 10%1 study (1/-)69.2 %NAnot evaluable non important-
Constipation AE (grade 3-4) 1.90 [0.17, 21.07]< 10%1 study (1/-)30.1 %NAnot evaluable non important-
Cough AE (grade 3-4) 0.95 [0.02, 47.95]< 10%1 study (1/-)51.0 %NAnot evaluable non important-
Decreased appetite AE (grade 3-4) 1.43 [0.40, 5.11]< 10%1 study (1/-)29.1 %NAnot evaluable non important-
Diarrhoea AE (grade 3-4) 2.12 [0.73, 6.17]< 10%1 study (1/-)8.4 %NAnot evaluable non important-
Dyspnoea AE (grade 3-4) 1.11 [0.37, 3.33]< 10%1 study (1/-)42.7 %NAnot evaluable non important-
Fatigue AE (grade 3-4) 1.31 [0.52, 3.31]< 10%1 study (1/-)28.1 %NAnot evaluable non important-
Nausea AE (grade 3-4) 0.63 [0.18, 2.25]< 10%1 study (1/-)76.2 %NAnot evaluable non important-
Neutropenia AE (grade 3-4) 0.01 [0.00, 0.19]< 10%1 study (1/-)99.9 %NAnot evaluable non important-
Pruritus AE (grade 3-4) 0.95 [0.02, 47.95]< 10%1 study (1/-)51.0 %NAnot evaluable non important-
Pyrexia AE (grade 3-4) 0.95 [0.02, 47.95]< 10%1 study (1/-)51.0 %NAnot evaluable non important-
Rash AE (grade 3-4) 0.95 [0.06, 15.23]< 10%1 study (1/-)51.5 %NAnot evaluable non important-
Thrombocytopenia AE (grade 3-4) 0.03 [0.00, 0.42]< 10%1 study (1/-)99.4 %NAnot evaluable non important-
Vomiting AE (grade 3-4) 0.13 [0.02, 1.09]< 10%1 study (1/-)96.9 %NAnot evaluable non important-
Weight decreased AE (grade 3-4) 2.86 [0.30, 27.64]< 10%1 study (1/-)18.3 %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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