Table 2.
Most Common (≥10%) Treatment-Emergent Adverse Events Related to Study Treatment
| |
DURV1500-LY 20 mg/day (N = 3)a |
DURV1500-LY 30 mg/day (N = 3)a |
DURV1500-LY 40 mg/day (N = 3)a |
Total (N = 9) |
||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Event (n, %) | Grade 1–2 | Grade ≥3 | Any grade | Grade 1–2 | Grade ≥3 | Any grade | Grade 1–2 | Grade ≥3 | Any grade | Grade 1–2 | Grade ≥3 | Any grade |
| Injection-site reaction | 1 (33.3) | 0 (0) | 1 (33.3) | 1 (33.3) | 0 (0) | 1 (33.3) | 2 (66.7) | 0 (0) | 2 (66.7) | 4 (44.4) | 0 (0) | 4 (44.4) |
| Fatigue | 0 (0) | 0 (0) | 0 (0) | 2 (66.7) | 0 (0) | 2 (66.7) | 1 (33.3) | 0 (0) | 1 (33.3) | 3 (33.3) | 0 (0) | 3 (33.3) |
| White blood cell count increased | 2 (66.7) | 0 (0) | 2 (66.7) | 1 (33.3) | 0 (0) | 1 (33.3) | 0 (0) | 0 (0) | 0 (0) | 3 (33.3) | 0 (0) | 3 (33.3) |
| Decreased appetite | 0 (0) | 0 (0) | 0 (0) | 2 (66.7) | 0 (0) | 2 (66.7) | 0 (0) | 0 (0) | 0 (0) | 2 (22.2) | 0 (0) | 2 (22.2) |
| Back pain | 0 (0) | 0 (0) | 0 (0) | 1 (33.3) | 0 (0) | 1 (33.3) | 1 (33.3) | 0 (0) | 1 (33.3) | 2 (22.2) | 0 (0) | 2 (22.2) |
| Hypothyroidism | 0 (0) | 0 (0) | 0 (0) | 1 (33.3) | 0 (0) | 1 (33.3) | 1 (33.3) | 0 (0) | 1 (33.3) | 2 (22.2) | 0 (0) | 2 (22.2) |
| Constipation | 0 (0) | 0 (0) | 0 (0) | 2 (66.7) | 0 (0) | 2 (66.7) | 0 (0) | 0 (0) | 0 (0) | 2 (22.2) | 0 (0) | 2 (22.2) |
| Nausea | 0 (0) | 0 (0) | 0 (0) | 2 (66.7) | 0 (0) | 2 (66.7) | 0 (0) | 0 (0) | 0 (0) | 2 (22.2) | 0 (0) | 2 (22.2) |
| Leukocytosis | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 1 (33.3) | 1 (33.3) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 1 (11.1) | 1 (11.1) |
| Neutropenia | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 1 (33.3) | 1 (33.3) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 1 (11.1) | 1 (11.1) |
| Pancreatic carcinoma metastaticb | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 1 (33.3) | 1 (33.3) | 0 (0) | 1 (11.1) | 1 (11.1) |
Dose of durvalumab kept constant at 1500 mg every 4 weeks for all cohorts.
Nodules in injection area defined as metastases by investigator. See the Safety section for details.
DURV, durvalumab; LY, LY2510924.