Statistically conclusive or suggested result Inconclusive results Uncertain results Safety results

metastatic/advanced NSCLC (mNSCLC) - 2nd line (L2) metastatic/advanced NSCLC (mNSCLC) - 2nd line (L2)

mNSCLC - L2 - all population metastatic/advanced NSCLC (mNSCLC) - 2nd line (L2) mNSCLC - L2 - all population

versus docetaxel
avelumab alone vs. docetaxel 1 noneinconclusive results for: deaths (OS); progression or deaths (PFS); objective responses (ORR); Acute kidney injury TRAE (grade 3-4); Adrenal insufficiency TRAE (grade 3-4); Alopecia TRAE (grade 3-4); Arthralgia TRAE (grade 3-4); Colitis TRAE (grade 3-4); Decreased appetite TRAE (grade 3-4); Diarrhoea TRAE (grade 3-4); Dyspnoea TRAE (grade 3-4); Headache TRAE (grade 3-4); Hypersensitivity TRAE (grade 3-4); Hypertension TRAE (grade 3-4); Hypothyroidism TRAE (grade 3-4); Increased ALT TRAE (grade 3-4); Increased lipase level TRAE (grade 3-4); Infusion-related reactions TRAE (grade 3-4); Mucosal inflammation TRAE (grade 3-4); Myalgia TRAE (grade 3-4); Myocarditis TRAE (grade 3-4); Nausea TRAE (grade 3-4); Palmar-plantar erythrodysaesthesia syndrome TRAE (grade 3-4); Peripheral neuropathy TRAE (grade 3-4); Peripheral oedema TRAE (grade 3-4); Peripheral sensory neuropathy TRAE (grade 3-4); Pneumonia TRAE (grade 3-4); Pneumonitis TRAE (grade 3-4); Pyrexia TRAE (grade 3-4); Sepsis TRAE (grade 3-4); Stomatitis TRAE (grade 3-4); Vomiting TRAE (grade 3-4); Weight decreased TRAE (grade 3-4)

suggested 63 % decrease in STRAE (any grade) but the degree if certainty is unassessable

suggested 71 % decrease in TRAE (any grade) but the degree if certainty is unassessable

suggested 88 % decrease in TRAE (grade 3-4) but the degree if certainty is unassessable

suggested 81 % decrease in TRAE leading to death (grade 5) but the degree if certainty is unassessable

suggested 53 % decrease in TRAE leading to discontinuation (any grade) but the degree if certainty is unassessable

suggested 97 % decrease in Anaemia TRAE (grade 3-4) but the degree if certainty is unassessable

suggested 94 % decrease in Asthenia TRAE (grade 3-4) but the degree if certainty is unassessable

suggested 91 % decrease in Fatigue TRAE (grade 3-4) but the degree if certainty is unassessable

suggested 99 % decrease in Febrile neutropenia TRAE (grade 3-4) but the degree if certainty is unassessable

suggested 95 % decrease in Leucopenia TRAE (grade 3-4) but the degree if certainty is unassessable

suggested 99 % decrease in Neutropenia TRAE (grade 3-4) but the degree if certainty is unassessable

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mNSCLC - L2 - EGFR mutant metastatic/advanced NSCLC (mNSCLC) - 2nd line (L2) mNSCLC - L2 - EGFR mutant

mNSCLC - L2 - PDL1 negative metastatic/advanced NSCLC (mNSCLC) - 2nd line (L2) mNSCLC - L2 - PDL1 negative

mNSCLC - L2 - PDL1 positive metastatic/advanced NSCLC (mNSCLC) - 2nd line (L2) mNSCLC - L2 - PDL1 positive

versus docetaxel
avelumab alone vs. docetaxel 1 noneinconclusive results for: deaths (OS); progression or deaths (PFS); DOR

suggested 76 % increase in objective responses (ORR) but the degree if certainty is unassessable

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non squamous - mNSCLC - L2 - all population metastatic/advanced NSCLC (mNSCLC) - 2nd line (L2) non squamous cell - mNSCLC - L2 non squamous - mNSCLC - L2 - all population

squamous - mNSCLC - L2 - all population metastatic/advanced NSCLC (mNSCLC) - 2nd line (L2) squamous cell - mNSCLC - L2 squamous - mNSCLC - L2 - all population