deaths (OS) deaths (OS) (extension) DOR DOR (extension) objective responses (ORR) objective responses (ORR) (extension) PFS (extension) progression or deaths (PFS) RFS/DFS AE (any grade) AE (grade 3-4) AE leading to death (grade 5) AE leading to treatment discontinuation (any grade) AE leading to treatment discontinuation (grade 3-4) STRAE (any grade) STRAE (grade 3-4) TRAE (any grade) TRAE (grade 3-4) TRAE leading to death (grade 5) TRAE leading to discontinuation (any grade) TRAE leading to discontinuation (grade 3-4) Abdominal pain TRAE (grade 3-4) Acute kidney injury TRAE (grade 3-4) Adrenal insufficiency TRAE (grade 3-4) Alopecia TRAE (grade 3-4) Anaemia TRAE (grade 3-4) Arthralgia TRAE (grade 3-4) Arthritis TRAE (grade 3-4) Asthenia TRAE (grade 3-4) Back pain (TRAE grade 3-4) Blood creatinine increased TRAE (grade 3-4) Chills TRAE (grade 3-4) Colitis TRAE (grade 3-4) Constipation TRAE (grade 3-4) Cough TRAE (grade 3-4) Decreased appetite TRAE (grade 3-4) Diabetes TRAE (grade 3-4) Diarrhoea TRAE (grade 3-4) Dizziness TRAE (grade 3-4) Dry skin TRAE (grade 3-4) Dysgeusia TRAE (grade 3-4) Dyspepsia TRAE (grade 3-4) Dyspnoea TRAE (grade 3-4) Epistaxis TRAE (grade 3-4) Fatigue TRAE (grade 3-4) Febrile neutropenia TRAE (grade 3-4) Headache TRAE (grade 3-4) Hepatitis TRAE (grade 3-4) Hypersensitivity TRAE (grade 3-4) Hyperthyroidism TRAE (grade 3-4) Hypophysitis TRAE (grade 3-4) Hypothyroidism TRAE (grade 3-4) Increase AST TRAE (grade 3-4) Increased ALT TRAE (grade 3-4) Increased lacrimation (TRAE grade 3-4) Infusion-related reactions TRAE (grade 3-4) Leucopenia TRAE (grade 3-4) Maculopapular rash TRAE (grade 3-4) Mucosal inflammation TRAE (grade 3-4) Myalgia TRAE (grade 3-4) Myocarditis TRAE (grade 3-4) Myositis TRAE (grade 3-4) Nausea TRAE (grade 3-4) Nephritis TRAE (grade 3-4) Neutropenia TRAE (grade 3-4) Palmar-plantar erythrodysaesthesia syndrome TRAE (grade 3-4) Pancreatitis TRAE (grade 3-4) Pancytopenia TRAE (grade 3-4) Paraesthesia 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) Pruritic rash TRAE (grade 3-4) Pruritus TRAE (grade 3-4) Pyrexia TRAE (grade 3-4) Rash TRAE (grade 3-4) Sepsis TRAE (grade 3-4) Severe skin reaction TRAE (grade 3-4) Stomatitis TRAE (grade 3-4) Thrombocytopenia TRAE (grade 3-4) Thyroiditis TRAE (grade 3-4) Urticaria TRAE (grade 3-4) Vomiting TRAE (grade 3-4) Weight decreased TRAE (grade 3-4) hepatitis (Autoimmune) AE (grade 3-4) Alopecia AE (grade 3-4) Anaemia AE (grade 3-4) Arthralgia AE (grade 3-4) Asthenia AE (grade 3-4) Colitis AE (grade 3-4) Constipation AE (grade 3-4) Cough AE (grade 3-4) Decreased appetite AE (grade 3-4) Diarrhoea AE (grade 3-4) Dyspnoea AE (grade 3-4) Epistaxis AE (grade 3-4) Fatigue AE (grade 3-4) Hyperthyroidism AE (grade 3-4) Hypophysitis AE (grade 3-4) Hypothyroidism AE (grade 3-4) Infusion-related reaction AE (grade 3-4) Lacrimation increased AE (grade 3-4) Myalgia AE (grade 3-4) Nausea AE (grade 3-4) Neutropenia AE (grade 3-4) Peripheral neuropathy AE (grade 3-4) Peripheral oedema AE (grade 3-4) Pneumonitis AE (grade 3-4) Pyrexia AE (grade 3-4) Rash AE (grade 3-4) Severe skin reactions AE (grade 3-4) Thrombocytopenia AE (grade 3-4) Thyroiditis AE (grade 3-4) Vomiting AE (grade 3-4)
deaths (OS)
lung cancer : non small cell (NSCLC) lung cancer : non small cell (NSCLC) locally advanced NSCLC - (neo)adjuvant (NA) locally advanced NSCLC - (neo)adjuvant (NA) laNSCLC - M - all population locally advanced NSCLC - maintenance (M) laNSCLC - M - all population mNSCLC - L1 - all population metastatic/advanced NSCLC (mNSCLC) - 1st line (L1) mNSCLC - L1 - all population mNSCLC - L1 - PDL1 negative metastatic/advanced NSCLC (mNSCLC) - 1st line (L1) mNSCLC - L1 - PDL1 negative mNSCLC - L1 - PDL1 positive metastatic/advanced NSCLC (mNSCLC) - 1st line (L1) mNSCLC - L1 - PDL1 positive pembrolizumab alone vs. Standard of Care (SoC) 4 statistically conclusive -24% mNSCLC - L1 - TMB>10Mb metastatic/advanced NSCLC (mNSCLC) - 1st line (L1) mNSCLC - L1 - TMB 10Mb non squamous - mNSCLC - L1 - all population metastatic/advanced NSCLC (mNSCLC) - 1st line (L1) non squamous cell - mNSCLC - L1 non squamous - mNSCLC - L1 - all population non squamous - mNSCLC - L1 - Wild Type (WT) metastatic/advanced NSCLC (mNSCLC) - 1st line (L1) non squamous cell - mNSCLC - L1 non squamous - mNSCLC - L1 - Wild Type (WT) pembrolizumab and pemetrexed plus platin vs. pemetrexed plus platin 1 certainty unassessable -9% pembrolizumab plus SoC vs. placebo plus SoC 1 certainty unassessable statistically conclusive -47% squamous - mNSCLC - L1 - all population metastatic/advanced NSCLC (mNSCLC) - 1st line (L1) squamous cell - mNSCLC - L1 squamous - mNSCLC - L1 - all population pembrolizumab plus SoC vs. placebo plus SoC 1 certainty unassessable statistically conclusive -33% 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 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 pembrolizumab (10mg/kg) vs. docetaxel 2 low degree of certainty statistically conclusive -39% pembrolizumab (2mg/kg) vs. docetaxel 2 low degree of certainty statistically conclusive -33% 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 NSCLC neoadjuvant setting NSCLC neoadjuvant setting