| Statistically conclusive or suggested result | Inconclusive results | Uncertain results | Safety results | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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mHNSCC - L1 - all population metastatic-recurrent HNSCC (mHNSCC) mHNSCC - 1st line (L1) mHNSCC - L1 - all population | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus cetuximab plus platin plus 5FU | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| pembrolizumab alone vs. cetuximab plus platin plus 5FU | 1 | none | inconclusive results for: progression or deaths (PFS); DOR; objective responses (ORR); AE leading to death (grade 5); TRAE leading to death (grade 5); Adrenal insufficiency TRAE (grade 3-4); Asthenia TRAE (grade 3-4); Blood creatinine increased TRAE (grade 3-4); Colitis TRAE (grade 3-4); Constipation TRAE (grade 3-4); Diarrhoea TRAE (grade 3-4); Endocrine disorders TRAE (grade 3-4) ; Hepatitis TRAE (grade 3-4); Hyperthyroidism TRAE (grade 3-4); Hypophysitis TRAE (grade 3-4); Infusion-related reactions TRAE (grade 3-4); Myocarditis TRAE (grade 3-4); Myositis TRAE (grade 3-4); Nephritis TRAE (grade 3-4); Pancreatitis TRAE (grade 3-4); Pneumonitis TRAE (grade 3-4); Skin and subcutaneous tissue disorders TRAE (grade 3-4) ; Thyroiditis TRAE (grade 3-4); Uveitis TRAE (grade 3-4); Vomiting TRAE (grade 3-4); Weight decreased TRAE (grade 3-4); Abdominal pain AE (grade 3-4); Acute kidney injury AE (grade 3-4); Asthenia AE (grade 3-4); Decreased appetite AE (grade 3-4); Diarrhoea AE (grade 3-4); Dyspnoea AE (grade 3-4); Fatigue AE (grade 3-4); Hypertension AE (grade 3-4); Hypothyroidism AE (grade 3-4); Increase AST AE (grade 3-4); Pneumonitis AE (grade 3-4); Renal and urinary disorders AE (grade 3-4); Respiratory, thoracic and mediastinal disorders AE (grade 3-4); Sepsis AE (grade 3-4); Skin and subcutaneous tissue disorders AE (grade 3-4); Vascular disorders AE (grade 3-4); Weight decreased AE (grade 3-4) | suggested 17 % decrease in deaths (OS) but the degree if certainty is unassessable suggested 69 % decrease in AE (any grade) but the degree if certainty is unassessable suggested 95 % decrease in TRAE (any grade) but the degree if certainty is unassessable suggested 91 % decrease in TRAE (grade 3-4) but the degree if certainty is unassessable suggested 96 % decrease in Anaemia TRAE (grade 3-4) but the degree if certainty is unassessable suggested 75 % decrease in Fatigue TRAE (grade 3-4) but the degree if certainty is unassessable suggested 97 % decrease in Leucopenia TRAE (grade 3-4) but the degree if certainty is unassessable suggested 97 % decrease in Nausea 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 suggested 89 % decrease in Rash TRAE (grade 3-4) but the degree if certainty is unassessable suggested 95 % decrease in Stomatitis TRAE (grade 3-4) but the degree if certainty is unassessable suggested 76 % decrease in Anaemia AE (grade 3-4) but the degree if certainty is unassessable suggested 97 % decrease in Leucopenia AE (grade 3-4) but the degree if certainty is unassessable suggested 97 % decrease in Nausea AE (grade 3-4) but the degree if certainty is unassessable suggested 99 % decrease in Neutropenia AE (grade 3-4) but the degree if certainty is unassessable suggested 89 % decrease in Rash AE (grade 3-4) but the degree if certainty is unassessable suggested 95 % decrease in Stomatitis AE (grade 3-4) but the degree if certainty is unassessable suggested 88 % decrease in Vomiting AE (grade 3-4) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| pembrolizumab plus 5FU plus platin vs. cetuximab plus platin plus 5FU | 1 | none | inconclusive results for: progression or deaths (PFS); DOR; objective responses (ORR); AE (grade 3-4); AE leading to death (grade 5); AE leading to treatment discontinuation (any grade); TRAE (any grade); TRAE (grade 3-4); TRAE leading to death (grade 5); Adrenal insufficiency TRAE (grade 3-4); Anaemia TRAE (grade 3-4); Asthenia TRAE (grade 3-4); Blood and lymphatic system disorders TRAE (grade 3-4); Blood creatinine increased TRAE (grade 3-4); Colitis TRAE (grade 3-4); Constipation TRAE (grade 3-4); Decreased appetite TRAE (grade 3-4); Diarrhoea TRAE (grade 3-4); Endocrine disorders TRAE (grade 3-4) ; Fatigue TRAE (grade 3-4); General disorders and administration site conditions TRAE (grade 3-4); Hepatitis TRAE (grade 3-4); Hyperthyroidism TRAE (grade 3-4); Hypophysitis TRAE (grade 3-4); Hypothyroidism TRAE (grade 3-4); Infusion-related reactions TRAE (grade 3-4); Leucopenia TRAE (grade 3-4); Metabolism and nutrition disorders TRAE (grade 3-4); Mucosal inflammation 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); Pancreatitis TRAE (grade 3-4); Pneumonitis TRAE (grade 3-4); Stomatitis TRAE (grade 3-4); Thrombocytopenia TRAE (grade 3-4); Thyroiditis TRAE (grade 3-4); Uveitis TRAE (grade 3-4); Vomiting TRAE (grade 3-4); Weight decreased TRAE (grade 3-4); Abdominal pain AE (grade 3-4); Acute kidney injury AE (grade 3-4); Anaemia AE (grade 3-4); Asthenia AE (grade 3-4); Blood and lymphatic system disorders AE (grade 3-4); Decreased appetite AE (grade 3-4); Diarrhoea AE (grade 3-4); Dyspnoea AE (grade 3-4); Fatigue AE (grade 3-4); Febrile neutropenia AE (grade 3-4); Gastrointestinal disorders AE (grade 3-4); General disorders and administration site conditions AE (grade 3-4); Hypertension AE (grade 3-4); Increase AST AE (grade 3-4); Leucopenia AE (grade 3-4); Metabolism and nutrition disorders AE (grade 3-4); Mucosal inflammation AE (grade 3-4); Nausea AE (grade 3-4); Nervous system disorders AE (grade 3-4); Neutropenia AE (grade 3-4); Pneumonitis AE (grade 3-4); Renal and urinary disorders AE (grade 3-4); Respiratory, thoracic and mediastinal disorders AE (grade 3-4); Sepsis AE (grade 3-4); Skin and subcutaneous tissue disorders AE (grade 3-4); Stomatitis AE (grade 3-4); Thrombocytopenia AE (grade 3-4); Vascular disorders AE (grade 3-4); Vomiting AE (grade 3-4); Weight decreased AE (grade 3-4) | statistically conclusive 23 % decrease in deaths (OS) but the degree if certainty is unassessable suggested 28 % decrease in deaths (OS) (extension) but the degree if certainty is unassessable suggested 94 % decrease in Rash TRAE (grade 3-4) but the degree if certainty is unassessable suggested 94 % decrease in Rash AE (grade 3-4) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
mHNSCC - L1 - PDL1 positive metastatic-recurrent HNSCC (mHNSCC) mHNSCC - 1st line (L1) mHNSCC - L1 - PDL1 positive | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus cetuximab plus platin plus 5FU | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| pembrolizumab alone vs. cetuximab plus platin plus 5FU | 2 | none | inconclusive results for: progression or deaths (PFS); DOR; objective responses (ORR) | statistically conclusive 22 % decrease in deaths (OS) but the degree if certainty is unassessable suggested 26 % decrease in deaths (OS) (extension) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| pembrolizumab plus 5FU plus platin vs. cetuximab plus platin plus 5FU | 2 | none | inconclusive results for: progression or deaths (PFS); DOR; objective responses (ORR) | statistically conclusive 37 % decrease in deaths (OS) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
mHNSCC - L2 - all population metastatic-recurrent HNSCC (mHNSCC) mHNSCC - 2nd line (L2) mHNSCC - L2 - all population | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus Standard of Care (SoC) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| durvalumab alone vs. Standard of Care (SoC) | 1 | none | inconclusive results for: deaths (OS); progression or deaths (PFS); DCR; DOR; objective responses (ORR); AE (grade 3-4); AE leading to death (grade 5); AE leading to treatment discontinuation (any grade); SAE (any grade); STRAE (any grade); TRAE leading to death (grade 5); TRAE leading to discontinuation (any grade); Alopecia TRAE (grade 3-4); Asthenia TRAE (grade 3-4); Decreased appetite TRAE (grade 3-4); Dermatitis acneiform TRAE (grade 3-4); Diarrhoea TRAE (grade 3-4); Fatigue TRAE (grade 3-4); Hypothyroidism TRAE (grade 3-4); Increased ALT TRAE (grade 3-4); Leucopenia TRAE (grade 3-4); Mucosal inflammation TRAE (grade 3-4); Nausea TRAE (grade 3-4); Peripheral neuropathy TRAE (grade 3-4); Pruritus TRAE (grade 3-4); Rash TRAE (grade 3-4); Stomatitis TRAE (grade 3-4); Thrombocytopenia TRAE (grade 3-4) | suggested 55 % decrease in AE (any grade) but the degree if certainty is unassessable suggested 71 % decrease in TRAE (any grade) but the degree if certainty is unassessable suggested 65 % decrease in TRAE (grade 3-4) but the degree if certainty is unassessable suggested 96 % decrease in Anaemia TRAE (grade 3-4) but the degree if certainty is unassessable suggested 96 % decrease in Neutropenia TRAE (grade 3-4) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| durvalumab plus tremelimumab vs. Standard of Care (SoC) | 1 | none | inconclusive results for: deaths (OS); progression or deaths (PFS); DCR; DOR; objective responses (ORR); AE (any grade); AE (grade 3-4); AE leading to death (grade 5); AE leading to treatment discontinuation (any grade); SAE (any grade); TRAE leading to death (grade 5); TRAE leading to discontinuation (any grade); Alopecia TRAE (grade 3-4); Anaemia TRAE (grade 3-4); Asthenia TRAE (grade 3-4); Decreased appetite TRAE (grade 3-4); Dermatitis acneiform TRAE (grade 3-4); Diarrhoea TRAE (grade 3-4); Fatigue TRAE (grade 3-4); Hypothyroidism TRAE (grade 3-4); Increased ALT TRAE (grade 3-4); Leucopenia TRAE (grade 3-4); Mucosal inflammation TRAE (grade 3-4); Nausea TRAE (grade 3-4); Peripheral neuropathy TRAE (grade 3-4); Pruritus TRAE (grade 3-4); Rash TRAE (grade 3-4); Stomatitis TRAE (grade 3-4); Thrombocytopenia TRAE (grade 3-4) | suggested 66 % decrease in TRAE (any grade) but the degree if certainty is unassessable suggested 39 % decrease in TRAE (grade 3-4) but the degree if certainty is unassessable suggested 92 % decrease in Neutropenia TRAE (grade 3-4) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| nivolumab alone vs. Standard of Care (SoC) | 1 | inconclusive results for: PFS (extension); progression or deaths (PFS); TRAE leading to death (grade 5); TRAE leading to discontinuation (any grade); Acute kidney injury TRAE (grade 3-4); Adrenal insufficiency TRAE (grade 3-4); Alopecia TRAE (grade 3-4); Asthenia TRAE (grade 3-4); Colitis TRAE (grade 3-4); Decreased appetite TRAE (grade 3-4); Diarrhoea TRAE (grade 3-4); Dry skin TRAE (grade 3-4); Eczema TRAE (grade 3-4); Endocrine disorders TRAE (grade 3-4) ; Erythema TRAE (grade 3-4); Fatigue TRAE (grade 3-4); Gastrointestinal disorders TRAE (grade 3-4) ; Hepatobiliary disorders 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 lipase level 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); Nausea TRAE (grade 3-4); Neutropenia TRAE (grade 3-4); Palmar-plantar erythrodysaesthesia syndrome TRAE (grade 3-4); Peripheral neuropathy TRAE (grade 3-4); Pneumonitis TRAE (grade 3-4); Pruritus TRAE (grade 3-4); Pyrexia TRAE (grade 3-4); Renal and urinary disorders TRAE (grade 3-4) ; Respiratory, thoracic and mediastinal disorders TRAE (grade 3-4) ; Skin and subcutaneous tissue disorders TRAE (grade 3-4) ; Skin exfoliation 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); Rash AE (grade 3-4) | statistically conclusive 30 % decrease in deaths (OS) but the degree if certainty is unassessable suggested 32 % decrease in deaths (OS) (extension) but the degree if certainty is unassessable suggested 2.5-fold increase in objective responses (ORR) but the degree if certainty is unassessable suggested 77 % decrease in Anaemia TRAE (grade 3-4) but the degree if certainty is unassessable | - | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| pembrolizumab alone vs. Standard of Care (SoC) | 1 | none | inconclusive results for: progression or deaths (PFS); DOR; objective responses (ORR); TRAE leading to death (grade 5); TRAE leading to discontinuation (any grade); TRAE leading to discontinuation (grade 3-4); Acute kidney injury TRAE (grade 3-4); Adrenal insufficiency TRAE (grade 3-4); Alopecia TRAE (grade 3-4); Arthralgia TRAE (grade 3-4); Asthenia TRAE (grade 3-4); Blood creatinine increased TRAE (grade 3-4); Cardiac disorders 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); Diarrhoea TRAE (grade 3-4); Dyspepsia TRAE (grade 3-4); Dyspnoea TRAE (grade 3-4); Endocrine disorders TRAE (grade 3-4) ; Epistaxis TRAE (grade 3-4); Eye disorders TRAE (grade 3-4); Fatigue TRAE (grade 3-4); Gastritis TRAE (grade 3-4); General disorders and administration site conditions TRAE (grade 3-4); Guillain-Barré syndrome TRAE (grade 3-4); Headache TRAE (grade 3-4); Hepatitis TRAE (grade 3-4); Hepatobiliary disorders TRAE (grade 3-4) ; Hypersensitivity TRAE (grade 3-4); Hypertension TRAE (grade 3-4); Hyperthyroidism TRAE (grade 3-4); Hypothyroidism TRAE (grade 3-4); Increase AST TRAE (grade 3-4); Increased ALT TRAE (grade 3-4); Infusion-related reactions TRAE (grade 3-4); Leucopenia TRAE (grade 3-4); Maculopapular rash TRAE (grade 3-4); Metabolism and nutrition disorders TRAE (grade 3-4); Mucosal inflammation TRAE (grade 3-4); Musculoskeletal and connective tissue disorders TRAE (grade 3-4); Myalgia TRAE (grade 3-4); Nausea TRAE (grade 3-4); Nervous system disorders TRAE (grade 3-4); Palmar-plantar erythrodysaesthesia syndrome TRAE (grade 3-4); Pancytopenia TRAE (grade 3-4); Paraesthesia TRAE (grade 3-4); Peripheral oedema TRAE (grade 3-4); Pneumonitis TRAE (grade 3-4); Pruritic rash TRAE (grade 3-4); Pruritus generalised TRAE (grade 3-4); Pruritus TRAE (grade 3-4); Pyrexia TRAE (grade 3-4); Rash TRAE (grade 3-4); Renal and urinary disorders TRAE (grade 3-4) ; Respiratory, thoracic and mediastinal disorders TRAE (grade 3-4) ; Sepsis TRAE (grade 3-4); Severe skin reaction TRAE (grade 3-4); Skin and subcutaneous tissue disorders TRAE (grade 3-4) ; Skin exfoliation TRAE (grade 3-4); Stevens-Johnson syndrome TRAE (grade 3-4); Thrombocytopenia TRAE (grade 3-4); Vascular disorders TRAE (grade 3-4); Weight decreased TRAE (grade 3-4); Back pain AE (grade 3-4); Dizziness AE (grade 3-4) | statistically conclusive 20 % decrease in deaths (OS) but the degree if certainty is unassessable suggested 67 % decrease in TRAE (any grade) but the degree if certainty is unassessable suggested 76 % decrease in TRAE (grade 3-4) but the degree if certainty is unassessable suggested 90 % decrease in Anaemia TRAE (grade 3-4) but the degree if certainty is unassessable suggested 96 % decrease in Neutropenia TRAE (grade 3-4) but the degree if certainty is unassessable suggested 92 % decrease in Stomatitis TRAE (grade 3-4) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
mHNSCC - L2 - PDL1 negative metastatic-recurrent HNSCC (mHNSCC) mHNSCC - 2nd line (L2) mHNSCC - L2 - PDL1 negative | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus durvalumab alone | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| durvalumab plus tremelimumab vs. durvalumab alone | 1 | none | inconclusive results for: deaths (OS); progression or deaths (PFS); DCR; DOR; objective responses (ORR); AE leading to treatment discontinuation (any grade); STRAE (any grade); TRAE (any grade); TRAE (grade 3-4); TRAE leading to death (grade 5); TRAE leading to discontinuation (any grade); Anaemia TRAE (grade 3-4); Asthenia TRAE (grade 3-4); Diarrhoea TRAE (grade 3-4); Fatigue TRAE (grade 3-4) | - | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus tremelimumab | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| durvalumab plus tremelimumab vs. tremelimumab | 1 | none | inconclusive results for: deaths (OS); progression or deaths (PFS); DOR; objective responses (ORR); AE leading to treatment discontinuation (any grade); TRAE (any grade); TRAE (grade 3-4); TRAE leading to death (grade 5); TRAE leading to discontinuation (any grade); Anaemia TRAE (grade 3-4); Asthenia TRAE (grade 3-4); Diarrhoea TRAE (grade 3-4); Fatigue TRAE (grade 3-4) | suggested 9.4-fold increase in DCR but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
mHNSCC - L2 - PDL1 positive metastatic-recurrent HNSCC (mHNSCC) mHNSCC - 2nd line (L2) mHNSCC - L2 - PDL1 positive | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus Standard of Care (SoC) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| pembrolizumab alone vs. Standard of Care (SoC) | 1 | none | inconclusive results for: progression or deaths (PFS); DOR | statistically conclusive 26 % decrease in deaths (OS) but the degree if certainty is unassessable suggested 90 % increase in objective responses (ORR) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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