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squamous - mNSCLC - L2 - all population, anti-PD-(L)1 , 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) 0.59 [0.44, 0.79]< 10%1 study (1/-)100.0 %NAnot evaluable crucial-
deaths (OS) (extension) 0.31 [0.14, 0.69]< 10%1 study (1/-)99.8 %NAnot evaluable important-
PFS (extension) 0.48 [0.24, 0.96]< 10%1 study (1/-)98.1 %NAnot evaluable important-
progression or deaths (PFS) 0.62 [0.47, 0.81]< 10%1 study (1/-)100.0 %NAnot evaluable important-
objective responses (ORR) 2.60 [1.26, 5.35]> 10%1 study (1/-)99.5 %NAnot evaluable non important-
objective responses (ORR) (extension) 0.53 [0.19, 1.48]> 10%1 study (1/-)11.4 %NAnot evaluable non important-

safety endpoints 00

SAE (grade 3-4) 0.10 [0.03, 0.33]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
STRAE (any grade) 0.23 [0.11, 0.51]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
TRAE (any grade) 0.22 [0.12, 0.41]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
TRAE (grade 3-4) 0.06 [0.03, 0.13]< 10%1 study (1/-)100.0 %NAnot evaluable non important-
TRAE leading to death (grade 5) 0.16 [0.01, 3.24]< 10%1 study (1/-)88.1 %NAnot evaluable non important-
TRAE leading to discontinuation (any grade) 0.28 [0.09, 0.89]< 10%1 study (1/-)98.5 %NAnot evaluable non important-
TRAE leading to discontinuation (grade 3-4) 0.23 [0.05, 1.13]< 10%1 study (1/-)96.5 %NAnot evaluable non important-

TRAE (grade 3-4) endpoints 00

Abdominal pain TRAE (grade 3-4) 0.49 [0.02, 14.75]< 10%1 study (1/-)65.7 %NAnot evaluable non important-
Alopecia TRAE (grade 3-4) 0.49 [0.02, 14.75]< 10%1 study (1/-)65.7 %NAnot evaluable non important-
Anaemia TRAE (grade 3-4) 0.12 [0.01, 2.29]< 10%1 study (1/-)91.8 %NAnot evaluable non important-
Arthralgia TRAE (grade 3-4) 0.98 [0.02, 50.00]< 10%1 study (1/-)50.3 %NAnot evaluable non important-
Asthenia TRAE (grade 3-4) 0.10 [0.01, 1.76]< 10%1 study (1/-)94.1 %NAnot evaluable non important-
Constipation TRAE (grade 3-4) 0.98 [0.02, 50.00]< 10%1 study (1/-)50.3 %NAnot evaluable non important-
Decreased appetite TRAE (grade 3-4) 0.98 [0.06, 15.91]< 10%1 study (1/-)50.4 %NAnot evaluable non important-
Diarrhoea TRAE (grade 3-4) 0.16 [0.01, 3.24]< 10%1 study (1/-)88.1 %NAnot evaluable non important-
Dizziness TRAE (grade 3-4) 0.98 [0.02, 50.00]< 10%1 study (1/-)50.3 %NAnot evaluable non important-
Fatigue TRAE (grade 3-4) 0.09 [0.01, 0.73]< 10%1 study (1/-)98.8 %NAnot evaluable non important-
Febrile neutropenia TRAE (grade 3-4) 0.03 [0.00, 0.58]< 10%1 study (1/-)99.0 %NAnot evaluable non important-
Leucopenia TRAE (grade 3-4) 0.19 [0.02, 1.66]< 10%1 study (1/-)93.2 %NAnot evaluable non important-
Mucosal inflammation TRAE (grade 3-4) 0.98 [0.02, 50.00]< 10%1 study (1/-)50.3 %NAnot evaluable non important-
Myalgia TRAE (grade 3-4) 0.98 [0.02, 50.00]< 10%1 study (1/-)50.3 %NAnot evaluable non important-
Nausea TRAE (grade 3-4) 0.24 [0.01, 5.45]< 10%1 study (1/-)81.1 %NAnot evaluable non important-
Neutropenia TRAE (grade 3-4) 0.01 [0.00, 0.15]< 10%1 study (1/-)99.9 %NAnot evaluable non important-
Paraesthesia TRAE (grade 3-4) 0.98 [0.02, 50.00]< 10%1 study (1/-)50.3 %NAnot evaluable non important-
Peripheral neuropathy TRAE (grade 3-4) 0.16 [0.01, 3.24]< 10%1 study (1/-)88.1 %NAnot evaluable non important-
Peripheral oedema TRAE (grade 3-4) 0.98 [0.02, 50.00]< 10%1 study (1/-)50.3 %NAnot evaluable non important-
Pneumonitis TRAE (grade 3-4) 1.98 [0.07, 59.45]< 10%1 study (1/-)34.9 %NAnot evaluable non important-
Pyrexia TRAE (grade 3-4) 0.49 [0.02, 14.75]< 10%1 study (1/-)65.7 %NAnot evaluable non important-
Rash TRAE (grade 3-4) 0.24 [0.01, 5.45]< 10%1 study (1/-)81.1 %NAnot evaluable non important-
Vomiting TRAE (grade 3-4) 0.49 [0.02, 14.75]< 10%1 study (1/-)65.7 %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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