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mNSCLC - L1 - all population, nivolumab plus ipilimumab , 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) 0.69 [0.55, 0.87]< 10%1 study (1/-)99.9 %NAnot evaluable crucial-
deaths (OS) (extension) 0.66 [0.55, 0.80]< 10%1 study (1/-)100.0 %NAnot evaluable important-
PFS (extension) 0.68 [0.57, 0.82]< 10%1 study (1/-)100.0 %NAnot evaluable important-
progression or deaths (PFS) 0.70 [0.57, 0.86]< 10%1 study (1/-)100.0 %NAnot evaluable important-
objective responses (ORR) 1.80 [1.31, 2.48]> 10%1 study (1/-)100.0 %NAnot evaluable non important-

safety endpoints 00

STRAE (any grade) 1.94 [1.36, 2.76]< 10%1 study (1/-)0.0 %NAnot evaluable non important-
STRAE (grade 3-4) 1.95 [1.33, 2.84]< 10%1 study (1/-)0.0 %NAnot evaluable non important-
TRAE (any grade) 1.55 [0.94, 2.55]< 10%1 study (1/-)4.2 %NAnot evaluable non important-
TRAE (grade 3-4) 1.44 [1.06, 1.94]< 10%1 study (1/-)0.9 %NAnot evaluable non important-
TRAE leading to death (grade 5) 1.14 [0.38, 3.43]< 10%1 study (1/-)40.8 %NAnot evaluable non important-
TRAE leading to discontinuation (any grade) 3.18 [1.94, 5.19]< 10%1 study (1/-)0.0 %NAnot evaluable non important-
TRAE leading to discontinuation (grade 3-4) 3.48 [2.00, 6.05]< 10%1 study (1/-)0.0 %NAnot evaluable non important-

TRAE (grade 3-4) endpoints 00

Adrenal insufficiency TRAE (grade 3-4) 7.88 [0.41, 149.53]< 10%1 study (1/-)8.7 %NAnot evaluable non important-
Anaemia TRAE (grade 3-4) 0.37 [0.22, 0.63]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
Asthenia TRAE (grade 3-4) 0.36 [0.09, 1.37]< 10%1 study (1/-)93.3 %NAnot evaluable non important-
Colitis TRAE (grade 3-4) 9.87 [0.54, 181.39]< 10%1 study (1/-)6.4 %NAnot evaluable non important-
Constipation TRAE (grade 3-4) 0.97 [0.02, 49.27]< 10%1 study (1/-)50.5 %NAnot evaluable non important-
Decreased appetite TRAE (grade 3-4) 0.97 [0.24, 3.93]< 10%1 study (1/-)51.4 %NAnot evaluable non important-
Diarrhoea TRAE (grade 3-4) 7.06 [1.59, 31.30]< 10%1 study (1/-)0.5 %NAnot evaluable non important-
Fatigue TRAE (grade 3-4) 3.97 [0.84, 18.81]< 10%1 study (1/-)4.2 %NAnot evaluable non important-
Febrile neutropenia TRAE (grade 3-4) 1.38 [0.60, 3.15]< 10%1 study (1/-)22.3 %NAnot evaluable non important-
Hypothyroidism TRAE (grade 3-4) 1.95 [0.07, 58.39]< 10%1 study (1/-)35.2 %NAnot evaluable non important-
Increased ALT TRAE (grade 3-4) 2.46 [0.47, 12.75]< 10%1 study (1/-)14.3 %NAnot evaluable non important-
Increased lipase level TRAE (grade 3-4) 7.55 [2.24, 25.47]< 10%1 study (1/-)0.1 %NAnot evaluable non important-
Maculopapular rash TRAE (grade 3-4) 4.93 [0.57, 42.41]< 10%1 study (1/-)7.4 %NAnot evaluable non important-
Nausea TRAE (grade 3-4) 1.63 [0.39, 6.89]< 10%1 study (1/-)25.2 %NAnot evaluable non important-
Neutropenia TRAE (grade 3-4) 0.71 [0.41, 1.24]< 10%1 study (1/-)88.7 %NAnot evaluable non important-
Pruritus TRAE (grade 3-4) 5.89 [0.29, 118.02]< 10%1 study (1/-)12.6 %NAnot evaluable non important-
Rash TRAE (grade 3-4) 11.88 [0.66, 213.53]< 10%1 study (1/-)4.8 %NAnot evaluable non important-
Thrombocytopenia TRAE (grade 3-4) 1.09 [0.44, 2.70]< 10%1 study (1/-)43.0 %NAnot evaluable non important-
Vomiting TRAE (grade 3-4) 1.17 [0.35, 3.88]< 10%1 study (1/-)39.7 %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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