Table 3:
Treatment-related adverse events (safety analysis set)
| Cohort 1, EGFR+/ALK+ (n=111) | Cohort 2, EGFR−/ALK−* (n=265) | Cohort 3, EGFR−/ALK−* (≥90%†; (n=68) |
|||||||
|---|---|---|---|---|---|---|---|---|---|
| Grade 1–2 | Grade 3 | Grade 4 | Grade 1–2 | Grade 3 | Grade 4 | Grade 1–2 | Grade 3 | Grade 4 | |
| Any events‡ | 47 (42%) | 4 (4%) | 2 (2%) | 135 (51%) | 20 (8%) | 2 (1%) | 34 (50%) | 12 (18%) | 0 |
| Fatigue | 7 (6%) | 0 | 0 | 28 (11%) | 1 (<1%) | 0 | 13 (19%) | 1 (1%) | 0 |
| Hypothyroidism | 10 (9%) | 0 | 0 | 17 (6%) | 0 | 0 | 9 (13%) | 0 | 0 |
| Asthenia | 4 (4%) | 0 | 0 | 26 (10%) | 1 (<1%) | 0 | 0 | 0 | 0 |
| Nausea | 6 (5%) | 0 | 0 | 15 (6%) | 1 (<1%) | 0 | 6 (9%) | 0 | 0 |
| Pruritus | 2 (2%) | 0 | 0 | 18 (7%) | 0 | 0 | 8 (12%) | 0 | 0 |
| Diarrhoea | 4 (4%) | 0 | 0 | 17 (6%) | 1 (<1%) | 0 | 3 (4%) | 2 (3%) | 0 |
| Vomiting | 6 (5%) | 0 | 0 | 4 (2%) | 2 (1%) | 0 | 2 (3%) | 0 | 0 |
| Anaemia | 1 (1%) | 0 | 0 | 7 (3%) | 0 | 0 | 0 | 1 (1%) | 0 |
| Pneumonitis | 1 (1%) | 1 (1%) | 0 | 3 (1%) | 3 (1%) | 0 | 1 (1%) | 0 | 0 |
| Aspartate aminotransferase increased | 1 (1%) | 0 | 0 | 1 (<1%) | 0 | 0 | 2 (3%) | 2 (3%) | 0 |
| Gamma-glutamyltransferase increased |
0 | 0 | 0 | 2 (1%) | 3 (1%) | 1 (<1%) | 0 | 0 | 0 |
| Infusion-related reaction | 0 | 1 (1%) | 0 | 3 (1%) | 1 (<1%) | 0 | 0 | 1 (1%) | 0 |
| Malaise | 2 (2%) | 0 | 0 | 2 (1%) | 1 (<1%) | 0 | 1 (1%) | 0 | 0 |
| Rash maculo-papular | 2 (2%) | 0 | 0 | 2 (1%) | 0 | 0 | 1 (1%) | 1 (1%) | 0 |
| Hypotension | 0 | 0 | 0 | 2 (1%) | 0 | 0 | 0 | 1 (1%) | 0 |
| Tumour flare | 0 | 0 | 0 | 2 (1%) | 1 (<1%) | 0 | 0 | 0 | 0 |
| Adrenal insufficiency | 0 | 0 | 0 | 1 (<1%) | 1 (<1%) | 0 | 0 | 0 | 0 |
| Bradycardia | 0 | 0 | 0 | 1 (<1%) | 1 (<1%) | 0 | 0 | 0 | 0 |
| Dermatitis | 0 | 0 | 0 | 0 | 1 (<1%) | 0 | 1 (1%) | 0 | 0 |
| Lymphocyte count decreased | 0 | 0 | 1 (1%) | 0 | 0 | 0 | 1 (1%) | 0 | 0 |
| Lymphopenia | 0 | 0 | 0 | 1 (<1%) | 0 | 1 (<1%) | 0 | 0 | 0 |
| Neutropenia | 0 | 0 | 0 | 0 | 1 (<1%) | 0 | 1 (1%) | 0 | 0 |
| Transaminases increased | 0 | 0 | 0 | 0 | 1 (<1%) | 0 | 0 | 1 (1%) | 0 |
| Abdominal pain | 0 | 0 | 0 | 0 | 1 (<1%) | 0 | 0 | 0 | 0 |
| Agitation | 0 | 0 | 0 | 0 | 1 (<1%) | 0 | 0 | 0 | 0 |
| Bronchitis | 0 | 1 (1%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Diabetes insipidus | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (1%) | 0 |
| Diverticulitis | 0 | 0 | 0 | 0 | 1 (<1%) | 0 | 0 | 0 | 0 |
| Gastrointestinal disorder | 0 | 0 | 0 | 0 | 1 (<1%) | 0 | 0 | 0 | 0 |
| Hepatic atrophy | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (1%) | 0 |
| Hepatic enzyme increased | 0 | 0 | 0 | 0 | 1 (<1%) | 0 | 0 | 0 | 0 |
| Hypokalaemia | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (1%) | 0 |
| Hypopituitarism | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (1%) | 0 |
| Hypovolaemic shock | 0 | 0 | 0 | 0 | 1 (<1%) | 0 | 0 | 0 | 0 |
| Meningitis | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (1%) | 0 |
| Neutrophil count decreased | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (1%) | 0 |
| Pericardial effusion | 0 | 1 (1%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Spinal cord compression | 0 | 1 (1%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Tumour haemorrhage | 0 | 0 | 1 (1%) | 0 | 0 | 0 | 0 | 0 | 0 |
Data are n (%). Grade 1–2 events occurring in at least 10% of patients in any cohort, and all events of grade 3 or worse. Adverse events are reported in accordance with the Medical Dictionary for Regulatory Activities (version 19.0)-preferred term. Events are listed in order of descending frequency in the total population. Events causally related to treatment, as assessed by the investigator; missing responses are counted as related. There were no treatment-related deaths at the time of analysis. Includes adverse events with an onset date on or after the date of first dose or pretreatment adverse events that increase in severity on or after the date of first durvalumab dose up to and including 90 days following the date of last dose of study medication or up to and including the date of initiation of the first subsequent therapy (whichever occurred first). EGER+=EGER tyrosine kinase mutations. ALK+= anaplastic lymphoma kinase (ALK) rearrangements. EGER−=EGER wild type. ALK−=ALK rearrangement negative.
Includes patients with unknown EGER/ALK status.
Tumour cells with membrane staining for programmed cell death ligand-1.
Each patient has been represented once with the maximum reported Common Terminology Criteria for Adverse Events (version 4.03) grade for each adverse event. If a patient has multiple events within an adverse event, then the maximum reported Common Terminology Criteria for Adverse Events grade across those events is counted for that preferred term.