| Statistically conclusive or suggested result | Inconclusive results | Uncertain results | Safety results | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
mGC or mGEJC - L1 - HER2 neg/PDL1 positive metastatic/advanced mGC or mGEJC mGC or mGEJC - 1st line (L1) mGC or mGEJC - L1 - HER2 neg/PDL1 positive | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus Standard of Care (SoC) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| nivolumab plus SoC vs. Standard of Care (SoC) | 2 | none | inconclusive results for: DOR; objective responses (ORR) | statistically conclusive 29 % decrease in deaths (OS) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
mGC or mGEJC - L1 - HER2 negative metastatic/advanced mGC or mGEJC mGC or mGEJC - 1st line (L1) mGC or mGEJC - L1 - HER2 negative | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus Standard of Care (SoC) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| nivolumab plus SoC vs. Standard of Care (SoC) | 1 | none | inconclusive results for: DOR; 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); Anaemia TRAE (grade 3-4); Asthenia 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); Gastrointestinal disorders TRAE (grade 3-4) ; Hepatobiliary disorders TRAE (grade 3-4) ; Increase AST TRAE (grade 3-4); Increased ALT TRAE (grade 3-4); Increased lipase level 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); Peripheral sensory neuropathy 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) ; Thrombocytopenia TRAE (grade 3-4); Vomiting TRAE (grade 3-4) | statistically conclusive 20 % decrease in deaths (OS) but the degree if certainty is unassessable suggested 23 % decrease in progression or deaths (PFS) but the degree if certainty is unassessable suggested 63 % increase in objective responses (ORR) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
mGC or mGEJC - L1 - PDL1 positive metastatic/advanced mGC or mGEJC mGC or mGEJC - 1st line (L1) mGC or mGEJC - L1 - PDL1 positive | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus placebo plus SoC | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| pembrolizumab alone vs. placebo plus SoC | 1 | none | inconclusive results for: progression or deaths (PFS); DOR; objective responses (ORR) | suggested 31 % decrease in deaths (OS) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| pembrolizumab plus SoC vs. placebo plus SoC | 2 | none | inconclusive results for: deaths (OS); progression or deaths (PFS); DOR; AE (any grade); AE (grade 3-4); AE leading to death (grade 5); AE leading to treatment discontinuation (any grade); TRAE (any grade); Alopecia TRAE (grade 3-4); Anaemia TRAE (grade 3-4); Asthenia TRAE (grade 3-4); Blood creatinine increased TRAE (grade 3-4); Constipation TRAE (grade 3-4); Decreased appetite 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); Fatigue TRAE (grade 3-4); Hypothyroidism TRAE (grade 3-4); Leucopenia 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); Peripheral sensory 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); Vomiting TRAE (grade 3-4); Weight decreased TRAE (grade 3-4) | suggested 60 % increase in objective responses (ORR) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus Standard of Care (SoC) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| pembrolizumab alone vs. Standard of Care (SoC) | 1 | none | inconclusive results for: deaths (OS); progression or deaths (PFS); DOR; objective responses (ORR); AE (any grade); AE leading to death (grade 5); Alopecia TRAE (grade 3-4); Blood creatinine increased TRAE (grade 3-4); Constipation TRAE (grade 3-4); Dizziness TRAE (grade 3-4); Dry skin TRAE (grade 3-4); Dysgeusia TRAE (grade 3-4); Hypothyroidism TRAE (grade 3-4); Leucopenia TRAE (grade 3-4); Palmar-plantar erythrodysaesthesia syndrome TRAE (grade 3-4); Peripheral neuropathy TRAE (grade 3-4); Pruritus TRAE (grade 3-4); Rash TRAE (grade 3-4); Thrombocytopenia TRAE (grade 3-4); Weight decreased TRAE (grade 3-4) | suggested 91 % decrease in AE (grade 3-4) but the degree if certainty is unassessable suggested 89 % decrease in TRAE (any grade) but the degree if certainty is unassessable suggested 90 % decrease in Anaemia TRAE (grade 3-4) but the degree if certainty is unassessable suggested 91 % decrease in Asthenia TRAE (grade 3-4) but the degree if certainty is unassessable suggested 80 % decrease in Diarrhoea TRAE (grade 3-4) but the degree if certainty is unassessable suggested 94 % decrease in Fatigue TRAE (grade 3-4) but the degree if certainty is unassessable suggested 95 % 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 95 % decrease in Stomatitis TRAE (grade 3-4) but the degree if certainty is unassessable suggested 97 % decrease in Vomiting TRAE (grade 3-4) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
mGC or mGEJC - L2 - all population metastatic/advanced mGC or mGEJC mGC or mGEJC - 2nd Line (L2) mGC or mGEJC - L2 - all population | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus paclitaxel | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| avelumab alone vs. paclitaxel | 1 | none | inconclusive results for: deaths (OS); progression or deaths (PFS); DCR; DOR; objective responses (ORR); 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); Diarrhoea TRAE (grade 3-4); Fatigue TRAE (grade 3-4); Febrile neutropenia 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); Nausea TRAE (grade 3-4); Vomiting TRAE (grade 3-4); Weight decreased TRAE (grade 3-4) | suggested 66 % decrease in TRAE (any grade) but the degree if certainty is unassessable suggested 78 % 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 98 % decrease in Neutropenia TRAE (grade 3-4) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| pembrolizumab alone vs. paclitaxel | 1 | none | inconclusive results for: deaths (OS); progression or deaths (PFS); DOR; objective responses (ORR); TRAE leading to death (grade 5); TRAE leading to discontinuation (any grade); Alopecia TRAE (grade 3-4); Anaemia TRAE (grade 3-4); Colitis TRAE (grade 3-4); Decreased appetite TRAE (grade 3-4); Diabetes TRAE (grade 3-4); Diarrhoea TRAE (grade 3-4); Fatigue 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); Nausea TRAE (grade 3-4); Pancreatitis TRAE (grade 3-4); Peripheral neuropathy TRAE (grade 3-4); Pneumonitis TRAE (grade 3-4); Severe skin reaction TRAE (grade 3-4) | suggested 79 % decrease in TRAE (any grade) but the degree if certainty is unassessable suggested 69 % decrease in TRAE (grade 3-4) but the degree if certainty is unassessable suggested 98 % decrease in Neutropenia TRAE (grade 3-4) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus placebo | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| nivolumab alone vs. placebo | 1 | inconclusive results for: DOR; 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); SAE (any grade); SAE (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); Colitis TRAE (grade 3-4); Decreased appetite TRAE (grade 3-4); Diarrhoea TRAE (grade 3-4); Fatigue 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); Maculopapular rash TRAE (grade 3-4); Nausea TRAE (grade 3-4); Pneumonitis TRAE (grade 3-4); Pruritus TRAE (grade 3-4); Pyrexia TRAE (grade 3-4); Rash TRAE (grade 3-4); Thyroiditis TRAE (grade 3-4); Abdominal pain AE (grade 3-4); Anaemia AE (grade 3-4); Asthenia AE (grade 3-4); Back pain AE (grade 3-4); Constipation AE (grade 3-4); Decreased appetite AE (grade 3-4); Diarrhoea AE (grade 3-4); Dyspepsia AE (grade 3-4); Dyspnoea AE (grade 3-4); Fatigue AE (grade 3-4); Increase AST AE (grade 3-4); Increased ALT AE (grade 3-4); Nausea AE (grade 3-4); Peripheral oedema AE (grade 3-4); Pruritus AE (grade 3-4); Pyrexia AE (grade 3-4); Rash AE (grade 3-4); Vomiting AE (grade 3-4); Weight decreased AE (grade 3-4) | suggested 37 % decrease in deaths (OS) but the degree if certainty is unassessable suggested 38 % decrease in deaths (OS) (extension) but the degree if certainty is unassessable suggested 40 % decrease in PFS (extension) but the degree if certainty is unassessable suggested 40 % decrease in progression or deaths (PFS) but the degree if certainty is unassessable suggested 99 % increase in DCR but the degree if certainty is unassessable | - | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
mGC or mGEJC - L2 - PDL1 positive metastatic/advanced mGC or mGEJC mGC or mGEJC - 2nd Line (L2) mGC or mGEJC - L2 - PDL1 positive | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus paclitaxel | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| pembrolizumab alone vs. paclitaxel | 1 | none | inconclusive results for: deaths (OS); progression or deaths (PFS); DOR; objective responses (ORR) | - | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
mGC or mGEJC - M - HER2 negative metastatic/advanced mGC or mGEJC mGC or mGEJC - maintenance (M) mGC or mGEJC - M - HER2 negative | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus Standard of Care (SoC) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| avelumab alone 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); SAE (any grade); STRAE (any grade); TRAE leading to death (grade 5) | suggested 53 % decrease in TRAE (any grade) but the degree if certainty is unassessable suggested 69 % decrease in TRAE (grade 3-4) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
mGC or mGEJC - M - HER2 neg/PDL1 positive metastatic/advanced mGC or mGEJC mGC or mGEJC - maintenance (M) mGC or mGEJC - M - HER2 neg/PDL1 positive | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus Standard of Care (SoC) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| avelumab alone vs. Standard of Care (SoC) | 1 | none | inconclusive results for: deaths (OS); progression or deaths (PFS) | - | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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