Table 3.
Summary of any-cause AEs in all treated patients.
| Patients with an event, n (%)a | NIVO 480 mg Q4W + Palbo 125 mg QD + ANZ 1 mg QD (n = 9) |
NIVO 480 mg Q4W + Palbo 100 mg QD + ANZ 1 mg QD (n = 12) |
||
|---|---|---|---|---|
| Any grade | Grade 3/4 | Any grade | Grade 3/4 | |
| Any-cause AEs | 9 (100) | 8 (88.9) | 12 (100) | 9 (75.0) |
| Any-cause AEs (with incidence of grade 3/4 events) in either group | ||||
| Increased ALT | 4 (44.4) | 3 (33.3) | 2 (16.7) | 1 (8.3) |
| Increased AST | 4 (44.4) | 3 (33.3) | 2 (16.7) | 1 (8.3) |
| Neutropaenia | 3 (33.3) | 2 (22.2) | 3 (25.0) | 2 (16.7) |
| Decreased white blood cell count | 2 (22.2) | 2 (22.2) | 3 (25.0) | 1 (8.3) |
| Anaemia | 2 (22.2) | 1 (11.1) | 1 (8.3) | 0 |
| Decreased neutrophil count | 1 (11.1) | 1 (11.1) | 5 (41.7) | 5 (41.7) |
| Rash | 1 (11.1) | 1 (11.1) | 1 (8.3) | 0 |
| Febrile neutropaenia | 1 (11.1) | 1 (11.1) | 0 | 0 |
| Hepatitis | 1 (11.1) | 1 (11.1) | 0 | 0 |
| Thrombocytopaenia | 1 (11.1) | 0 | 1 (8.3) | 1 (8.3) |
| Increased transaminases | 1 (11.1) | 0 | 1 (8.3) | 1 (8.3) |
| Leucopenia | 0 | 0 | 2 (16.7) | 1 (8.3) |
| Decreased appetite | 0 | 0 | 1 (8.3) | 1 (8.3) |
| Hypertransaminasaemia | 0 | 0 | 1 (8.3) | 1 (8.3) |
| Secondary primary malignancy |
0 |
0 |
1 (8.3) |
1 (8.3) |
|
Any-cause AEs leading to treatment discontinuation |
5 (55.6) |
4 (44.4) |
4 (33.3) |
3 (25.0) |
|
Any-cause AEs (with incidence of grade 3/4 events) in either group leading to treatment discontinuation | ||||
| Increased ALT | 3 (33.3) | 3 (33.3) | 1 (8.3) | 1 (8.3) |
| Increased AST | 3 (33.3) | 3 (33.3) | 0 | 0 |
| Febrile neutropaenia | 1 (11.1) | 1 (11.1) | 0 | 0 |
| Hepatitis | 1 (11.1) | 1 (11.1) | 0 | 0 |
| Hypertransaminasaemia | 0 | 0 | 1 (8.3) | 1 (8.3) |
| Increased transaminases |
0 |
0 |
1 (8.3) |
1 (8.3) |
| Any-cause SAEs (with incidence of grade 3/4 events) in either group | ||||
| Anaemia | 1 (11.1) | 1 (11.1) | 0 | 0 |
| Increased ALT | 1 (11.1) | 1 (11.1) | 0 | 0 |
| Increased AST | 1 (11.1) | 1 (11.1) | 0 | 0 |
| Febrile neutropaenia | 1 (11.1) | 1 (11.1) | 0 | 0 |
| Hepatitis | 1 (11.1) | 1 (11.1) | 0 | 0 |
| Rash | 1 (11.1) | 1 (11.1) | 0 | 0 |
| Hypertransaminasaemia | 0 | 0 | 1 (8.3) | 1 (8.3) |
| Secondary primary malignancy | 0 | 0 | 1 (8.3) | 1 (8.3) |
AE, adverse event; ALT, alanine aminotransferase; ANZ, anastrozole; AST, aspartate aminotransferase; NIVO, nivolumab; Palbo, palbociclib; Q4W, every 4 weeks; QD, once daily; SAE, serious adverse event.
a
Includes events reported between first dose and 30 days after last dose of study treatment.