Introduction
Methods
Study design and patients
Procedures and assessments
Statistical methods
Results
Patients
Characteristics | Total population N = 168 | TNBC subgroup (n = 58) |
---|---|---|
Median age, years (range) | 55 (31–81) | 52.5 (31–80) |
Age category, n (%) (years) | ||
< 65 | 140 (83.3) | 54 (93.1) |
≥ 65 | 28 (16.7) | 4 (6.9) |
Sex, n (%) | ||
Male | 1 (0.6) | 0 |
Female | 167 (99.4) | 58 (100) |
Race or ethnic group, n (%) | ||
White | 143 (85.1) | 45 (7.8) |
Black or African American | 16 (9.5) | 9 (15.5) |
Asian | 3 (1.8) | 1 (1.7) |
Other | 6 (3.6) | 3 (5.2) |
Geographic region, n (%) | ||
United States | 112 (66.7) | 48 (82.8) |
Europe | 56 (33.3) | 10 (17.2) |
ECOG PS, n (%) | ||
0 | 83 (49.4) | 33 (56.9) |
1 | 85 (50.6) | 25 (43.1) |
Smoking history, n (%) | ||
Never smoker | 107 (63.7) | 36 (62.1) |
Current or former smoker | 50 (29.8) | 17 (29.3) |
Unknown | 11 (6.5) | 5 (8.6) |
Histological subtype of tumor, n (%) | ||
Ductal | 94 (56.0) | 36 (62.1) |
Lobular | 6 (3.6) | 0 |
Carcinoma, not otherwise specified | 14 (8.3) | 6 (10.3) |
Othera
| 54 (32.1) | 16 (27.6) |
Molecular subtype, n (%) | ||
TNBC | 58 (34.5) | 58 (100) |
HER2−/ER+ or PR+ | 72 (42.9) | – |
HER2+ | 26 (15.5) | – |
Unknownb
| 12 (7.1) | – |
Median time since first diagnosis, months (range) | 53.5 (7.3–407.5) | 40.3 (7.3–241.0) |
Median time since diagnosis of metastatic disease, months (range)c
| 21.6 (0.7–176.8) | 13.2 (0.7–176.8) |
Prior anticancer lines of therapy for metastatic or locally advanced disease, n (%)d
| ||
≤ 1 | 45 (26.8) | 29 (50.0) |
2 | 35 (20.8) | 16 (27.6) |
≥ 3 | 88 (52.4) | 13 (22.4) |
Median (range) | 3 (0–10) | 2 (1–6) |
PD-L1 expression status, n/N (%)e
| PD-L1+ | PD-L1− | PD-L1+ | PD-L1− |
---|---|---|---|---|
≥ 1% tumor cells | 85/136 (62.5) | 51/136 (37.5) | 33/48 (68.8) | 15/48 (31.2) |
≥ 5% tumor cells | 23/136 (16.9) | 113/136 (83.1) | 13/48 (27.1) | 35/48 (72.9) |
≥ 25% tumor cells | 3/136 (2.2) | 133/136 (97.8) | 2/48 (4.2) | 46/48 (95.8) |
≥ 10% tumor-associated immune cells | 12/136 (8.8) | 124/136 (91.2) | 9/48 (18.8) | 39/48 (81.2) |
Safety
N = 168 | Any grade | Grades 1–2 | Grade 3 | Grade 4 | Grade 5 |
---|---|---|---|---|---|
Any event, n (%) | 115 (68.5) | 92 (54.8) | 16 (9.5) | 5 (3.0) | 2 (1.2) |
Fatigue | 32.9 (19.0) | 29 (17.3) | 3 (1.8) | 0 | 0 |
Infusion-related reaction | 24 (14.3) | 24 (14.3) | 0 | 0 | 0 |
Nausea | 22 (13.1) | 22 (13.1) | 0 | 0 | 0 |
Diarrhea | 15 (8.9) | 15 (8.9) | 0 | 0 | 0 |
Arthralgia | 13 (7.7) | 12 (7.1) | 1 (0.6) | 0 | 0 |
Decreased appetite | 12 (7.1) | 12 (7.1) | 0 | 0 | 0 |
Influenza-like illness | 11 (6.5) | 11 (6.5) | 0 | 0 | 0 |
Dyspnea exertional | 5 (3.0) | 4 (2.4) | 1 (0.6) | 0 | 0 |
Elevated AST | 4 (2.4) | 3 (1.8) | 1 (0.6) | 0 | 0 |
Elevated GGT | 4 (2.4) | 1 (0.6) | 1 (0.6) | 2 (1.2) | 0 |
Anemia | 3 (1.8) | 0 | 2 (1.2) | 1 (0.6) | 0 |
Autoimmune hepatitis | 3 (1.8) | 0 | 3 (1.8) | 0 | 0 |
Elevated ALT | 3 (1.8) | 2 (1.2) | 1 (0.6) | 0 | 0 |
Hypoxia | 3 (1.8) | 2 (1.2) | 1 (0.6) | 0 | 0 |
Pneumonitis | 3 (1.8) | 2 (1.2) | 1 (0.6) | 0 | 0 |
Axillary pain | 2 (1.2) | 1 (0.6) | 1 (0.6) | 0 | 0 |
Thrombocytopenia | 2 (1.2) | 1 (0.6) | 0 | 1 (0.6) | 0 |
Acute hepatic failure | 1 (0.6) | 0 | 0 | 0 | 1 (0.6) |
Cardiac arrest | 1 (0.6) | 0 | 0 | 1 (0.6) | 0 |
Hypertriglyceridemia | 1 (0.6) | 0 | 1 (0.6) | 0 | 0 |
Hypokalemia | 1 (0.6) | 0 | 0 | 1 (0.6) | 0 |
Neutropenia | 1 (0.6) | 0 | 0 | 1 (0.6) | 0 |
Neutrophil count decreased | 1 (0.6) | 0 | 1 (0.6) | 0 | 0 |
Noncardiac chest pain | 1 (0.6) | 0 | 1 (0.6) | 0 | 0 |
Pleuritic pain | 1 (0.6) | 0 | 1 (0.6) | 0 | 0 |
Proteinuria | 1 (0.6) | 0 | 1 (0.6) | 0 | 0 |
Pulmonary arterial hypertension | 1 (0.6) | 0 | 1 (0.6) | 0 | 0 |
Respiratory distress | 1 (0.6) | 0 | 0 | 0 | 1 (0.6) |
Respiratory failure | 1 (0.6) | 0 | 0 | 1 (0.6) | 0 |
Antitumor activity
Study population N = 168 | TNBC subgroup n = 58 | |
---|---|---|
Complete response, n (%) | 1 (0.6) | 0 |
Partial response, n (%) | 4 (2.4) | 3 (5.2) |
Stable disease,a n (%) | 42 (25.0) | 15 (25.9) |
Progressive disease, n (%) | 106 (63.1) | 38 (65.5) |
Nonevaluable,b n (%) | 15 (8.9) | 2 (3.4) |
ORR (95% CI) (%) | 3.0 (1.0 to 6.8) | 5.2 (1.1 to 14.4) |
DCR (%) | 28.0 | 31.0 |
Median (95% CI) duration of response in confirmed responders (weeks) | ne (28.7 to ne) | ne (ne to ne) |
Median (95% CI) progression-free survival (weeks) | 5.9 (5.9 to 6.0) | 5.9 (5.7 to 6.9) |
Progression-free survival rate at 24 weeks (95% CI) (%) | 10.1 (5.9 to15.5) | 12.4 (5.2 to 22.8) |
Median (95% CI) overall survival (months) | 8.1 (6.4 to ne) | 9.2 (4.3 to ne) |
Overall survival rate at 12 months (95% CI) (%) | 40.3 (29.6 to 50.7) | 37.1 (18.3 to 56.2) |